Viewing Study NCT03703102

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Ignite Creation Date: 2025-12-25 @ 4:01 AM
Ignite Modification Date: 2026-02-23 @ 12:19 PM
Study NCT ID: NCT03703102
Status: COMPLETED
Last Update Posted: 2024-04-26
First Post: 2018-10-09
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627613', 'term': 'KHK4083'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.info.jp@kyowakirin.com', 'phone': '+81-3-5205-7200', 'title': 'Research & Development Planning Department, Research & Development Division', 'organization': 'Kyowa Kirin Co., Ltd.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).", 'eventGroups': [{'id': 'EG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 47, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 50, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 48, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 51, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 46, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': "Kaposi's varicelliform eruption", 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 20, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Atopic cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Incarcerated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Small intestine ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Postoperative ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rectosigmoid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.33', 'groupId': 'OG000', 'lowerLimit': '-62.62', 'upperLimit': '-34.04'}, {'value': '-49.72', 'groupId': 'OG001', 'lowerLimit': '-62.47', 'upperLimit': '-35.17'}, {'value': '-61.07', 'groupId': 'OG002', 'lowerLimit': '-75.19', 'upperLimit': '-46.96'}, {'value': '-57.35', 'groupId': 'OG003', 'lowerLimit': '-71.27', 'upperLimit': '-43.43'}, {'value': '-15.01', 'groupId': 'OG004', 'lowerLimit': '-28.60', 'upperLimit': '-1.43'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.', 'unitOfMeasure': 'percentage of score change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.'}, {'type': 'SECONDARY', 'title': 'Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'title': 'Achieved EASI-50 at Week 16', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'achieved EASI-75 at Week 16', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'achieved EASI-90 at Week 16', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 16', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.5', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '-20.7', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '-23.3', 'spread': '9.0', 'groupId': 'OG002'}, {'value': '-19.9', 'spread': '11.8', 'groupId': 'OG003'}, {'value': '-9.8', 'spread': '13.0', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.71', 'groupId': 'OG000', 'lowerLimit': '-30.72', 'upperLimit': '-16.69'}, {'value': '-23.86', 'groupId': 'OG001', 'lowerLimit': '-30.92', 'upperLimit': '-16.81'}, {'value': '-30.44', 'groupId': 'OG002', 'lowerLimit': '-37.27', 'upperLimit': '-23.61'}, {'value': '-27.65', 'groupId': 'OG003', 'lowerLimit': '-34.39', 'upperLimit': '-20.91'}, {'value': '-8.09', 'groupId': 'OG004', 'lowerLimit': '-14.65', 'upperLimit': '-1.53'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.86', 'groupId': 'OG000', 'lowerLimit': '-45.20', 'upperLimit': '-24.51'}, {'value': '-35.13', 'groupId': 'OG001', 'lowerLimit': '-45.54', 'upperLimit': '-24.72'}, {'value': '-46.69', 'groupId': 'OG002', 'lowerLimit': '-56.77', 'upperLimit': '-36.61'}, {'value': '-40.76', 'groupId': 'OG003', 'lowerLimit': '-50.70', 'upperLimit': '-30.81'}, {'value': '-11.90', 'groupId': 'OG004', 'lowerLimit': '-21.59', 'upperLimit': '-2.22'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.', 'unitOfMeasure': 'percentage of score change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': "Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 16', 'description': 'In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.86', 'groupId': 'OG000', 'lowerLimit': '-30.30', 'upperLimit': '-15.42'}, {'value': '-21.48', 'groupId': 'OG001', 'lowerLimit': '-29.07', 'upperLimit': '-13.89'}, {'value': '-27.92', 'groupId': 'OG002', 'lowerLimit': '-35.30', 'upperLimit': '-20.54'}, {'value': '-25.04', 'groupId': 'OG003', 'lowerLimit': '-32.33', 'upperLimit': '-17.76'}, {'value': '-7.87', 'groupId': 'OG004', 'lowerLimit': '-14.96', 'upperLimit': '-0.77'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The Investigator will calculate the percentage (%) of the total body surface area affected by AD.', 'unitOfMeasure': 'percentage of total BSA involvement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.04', 'groupId': 'OG000', 'lowerLimit': '-2.90', 'upperLimit': '-1.18'}, {'value': '-3.02', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.15'}, {'value': '-3.60', 'groupId': 'OG002', 'lowerLimit': '-4.44', 'upperLimit': '-2.75'}, {'value': '-2.81', 'groupId': 'OG003', 'lowerLimit': '-3.64', 'upperLimit': '-1.97'}, {'value': '-1.31', 'groupId': 'OG004', 'lowerLimit': '-2.12', 'upperLimit': '-0.49'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.57', 'groupId': 'OG000', 'lowerLimit': '-39.48', 'upperLimit': '-11.66'}, {'value': '-34.38', 'groupId': 'OG001', 'lowerLimit': '-48.56', 'upperLimit': '-20.21'}, {'value': '-47.99', 'groupId': 'OG002', 'lowerLimit': '-61.71', 'upperLimit': '-34.26'}, {'value': '-36.83', 'groupId': 'OG003', 'lowerLimit': '-50.41', 'upperLimit': '-23.25'}, {'value': '-6.18', 'groupId': 'OG004', 'lowerLimit': '-6.18', 'upperLimit': '7.01'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."', 'unitOfMeasure': 'percentage of score change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.09', 'groupId': 'OG000', 'lowerLimit': '-2.01', 'upperLimit': '-0.18'}, {'value': '-1.93', 'groupId': 'OG001', 'lowerLimit': '-2.86', 'upperLimit': '-1.00'}, {'value': '-2.59', 'groupId': 'OG002', 'lowerLimit': '-3.48', 'upperLimit': '-1.69'}, {'value': '-2.00', 'groupId': 'OG003', 'lowerLimit': '-2.90', 'upperLimit': '-1.11'}, {'value': '-0.01', 'groupId': 'OG004', 'lowerLimit': '-0.87', 'upperLimit': '0.86'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.19', 'groupId': 'OG000', 'lowerLimit': '-44.32', 'upperLimit': '27.95'}, {'value': '-7.02', 'groupId': 'OG001', 'lowerLimit': '-44.96', 'upperLimit': '30.93'}, {'value': '-41.58', 'groupId': 'OG002', 'lowerLimit': '-78.30', 'upperLimit': '-4.86'}, {'value': '-33.17', 'groupId': 'OG003', 'lowerLimit': '-69.08', 'upperLimit': '2.74'}, {'value': '-46.54', 'groupId': 'OG004', 'lowerLimit': '-100.55', 'upperLimit': '-8.89'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).", 'unitOfMeasure': 'percentage of score change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.59', 'groupId': 'OG000', 'lowerLimit': '-4.73', 'upperLimit': '-0.44'}, {'value': '-4.66', 'groupId': 'OG001', 'lowerLimit': '-6.89', 'upperLimit': '-2.43'}, {'value': '-6.28', 'groupId': 'OG002', 'lowerLimit': '-8.38', 'upperLimit': '-4.18'}, {'value': '-4.93', 'groupId': 'OG003', 'lowerLimit': '-7.01', 'upperLimit': '-2.84'}, {'value': '0.19', 'groupId': 'OG004', 'lowerLimit': '-1.88', 'upperLimit': '2.27'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.'}, {'type': 'SECONDARY', 'title': 'EASI Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'EASI Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '63'}, {'value': '32.5', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '69'}, {'value': '31.6', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '64'}, {'value': '31.1', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '60'}, {'value': '29.2', 'groupId': 'OG004', 'lowerLimit': '16', 'upperLimit': '68'}]}]}, {'title': 'EASI Score at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '65'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '58'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '69'}, {'value': '29.4', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '57'}, {'value': '28.5', 'groupId': 'OG004', 'lowerLimit': '6', 'upperLimit': '62'}]}]}, {'title': 'EASI Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '67'}, {'value': '27.6', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '60'}, {'value': '25.6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '66'}, {'value': '27.2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '58'}, {'value': '28.1', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '71'}]}]}, {'title': 'EASI Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '71'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '56'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '49'}, {'value': '23.4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '68'}, {'value': '28.8', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '71'}]}]}, {'title': 'EASI Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '66'}, {'value': '21.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '57'}, {'value': '17.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '52'}, {'value': '19.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '52'}, {'value': '27.9', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '71'}]}]}, {'title': 'EASI Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '63'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '55'}, {'value': '15.2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '50'}, {'value': '17.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '51'}, {'value': '25.8', 'groupId': 'OG004', 'lowerLimit': '3', 'upperLimit': '67'}]}]}, {'title': 'EASI Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '65'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '47'}, {'value': '16.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '46'}, {'value': '25.5', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '72'}]}]}, {'title': 'EASI Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '53'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '47'}, {'value': '14.9', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '45'}, {'value': '23.6', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '72'}]}]}, {'title': 'EASI Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '62'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '55'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '45'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '44'}, {'value': '22.7', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '71'}]}]}, {'title': 'EASI Score at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '59'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '48'}, {'value': '11.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '20.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '72'}]}]}, {'title': 'EASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '62'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '48'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '40'}, {'value': '11.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '41'}, {'value': '20.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '72'}]}]}, {'title': 'EASI Score at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '60'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '41'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '39'}, {'value': '10.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '60'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '72'}]}]}, {'title': 'EASI Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '39'}, {'value': '7.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '8.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '38'}, {'value': '20.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '62'}]}]}, {'title': 'EASI Score at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '38'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '36'}, {'value': '16.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '60'}]}]}, {'title': 'EASI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '6.2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '46'}, {'value': '15.9', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '53'}]}]}, {'title': 'EASI Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '35'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '36'}, {'value': '5.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '46'}, {'value': '10.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '48'}]}]}, {'title': 'EASI Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '37'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '9.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '46'}]}]}, {'title': 'EASI Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '51'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '24'}, {'value': '8.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '38'}]}]}, {'title': 'EASI Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '64'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '3.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '6.3', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '27'}]}]}, {'title': 'EASI Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '67'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '27'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '3.4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '5.7', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'EASI Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '62'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '6.3', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '42'}]}]}, {'title': 'EASI Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '5.5', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'EASI Score at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '17'}]}]}, {'title': 'EASI Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '33'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '19'}]}]}, {'title': 'EASI Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'EASI Score at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '11'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in EASI Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'EASI Score % Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-55', 'upperLimit': '48'}, {'value': '-9.5', 'groupId': 'OG001', 'lowerLimit': '-68', 'upperLimit': '31'}, {'value': '-8.5', 'groupId': 'OG002', 'lowerLimit': '-72', 'upperLimit': '100'}, {'value': '-7.0', 'groupId': 'OG003', 'lowerLimit': '-89', 'upperLimit': '96'}, {'value': '-2.9', 'groupId': 'OG004', 'lowerLimit': '-63', 'upperLimit': '114'}]}]}, {'title': 'EASI Score % Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-71', 'upperLimit': '71'}, {'value': '-14.3', 'groupId': 'OG001', 'lowerLimit': '-75', 'upperLimit': '31'}, {'value': '-18.4', 'groupId': 'OG002', 'lowerLimit': '-88', 'upperLimit': '128'}, {'value': '-15.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '79'}, {'value': '-2.6', 'groupId': 'OG004', 'lowerLimit': '-72', 'upperLimit': '154'}]}]}, {'title': 'EASI Score % Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-19.6', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '78'}, {'value': '-19.4', 'groupId': 'OG001', 'lowerLimit': '-74', 'upperLimit': '42'}, {'value': '-26.4', 'groupId': 'OG002', 'lowerLimit': '-92', 'upperLimit': '167'}, {'value': '-24.6', 'groupId': 'OG003', 'lowerLimit': '-96', 'upperLimit': '57'}, {'value': '-8.5', 'groupId': 'OG004', 'lowerLimit': '-89', 'upperLimit': '58'}]}]}, {'title': 'EASI Score % Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-28.8', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '48'}, {'value': '-32.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '54'}, {'value': '-43.4', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '94'}, {'value': '-35.8', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '70'}, {'value': '-11.1', 'groupId': 'OG004', 'lowerLimit': '-89', 'upperLimit': '76'}]}]}, {'title': 'EASI Score % Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-40.3', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '118'}, {'value': '-45.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '29'}, {'value': '-52.2', 'groupId': 'OG002', 'lowerLimit': '-97', 'upperLimit': '37'}, {'value': '-42.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-19.2', 'groupId': 'OG004', 'lowerLimit': '-83', 'upperLimit': '150'}]}]}, {'title': 'EASI Score % Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-51.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '45'}, {'value': '-51.9', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '86'}, {'value': '-60.4', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-48.2', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-21.1', 'groupId': 'OG004', 'lowerLimit': '-91', 'upperLimit': '66'}]}]}, {'title': 'EASI Score % Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-56.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '24'}, {'value': '-58.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '9'}, {'value': '-68.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '26'}, {'value': '-50.9', 'groupId': 'OG003', 'lowerLimit': '-96', 'upperLimit': '12'}, {'value': '-29.5', 'groupId': 'OG004', 'lowerLimit': '-95', 'upperLimit': '61'}]}]}, {'title': 'EASI Score % Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-62.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '7'}, {'value': '-62.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '12'}, {'value': '-71.1', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '36'}, {'value': '-61.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-32.1', 'groupId': 'OG004', 'lowerLimit': '-95', 'upperLimit': '30'}]}]}, {'title': 'EASI Score % Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-67.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '2'}, {'value': '-62.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '6'}, {'value': '-74.1', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-9'}, {'value': '-62.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '19'}, {'value': '-35.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '81'}]}]}, {'title': 'EASI Score % Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-67.0', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '18'}, {'value': '-63.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '6'}, {'value': '-77.2', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-20'}, {'value': '-63.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '52'}, {'value': '-37.4', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '81'}]}]}, {'title': 'EASI Score % Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-67.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '10'}, {'value': '-66.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-6'}, {'value': '-75.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-13'}, {'value': '-63.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '233'}, {'value': '-32.6', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '81'}]}]}, {'title': 'EASI Score % Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-69.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '24'}, {'value': '-70.6', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-79.0', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-12'}, {'value': '-74.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-37.9', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '95'}]}]}, {'title': 'EASI Score % Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-74.3', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '24'}, {'value': '-75.6', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-5'}, {'value': '-80.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-12'}, {'value': '-79.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '33'}, {'value': '-49.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '95'}]}]}, {'title': 'EASI Score % Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-71.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '24'}, {'value': '-75.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-5'}, {'value': '-85.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '9'}, {'value': '-80.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '15'}, {'value': '-49.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '105'}]}]}, {'title': 'EASI Score % Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-75.3', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '24'}, {'value': '-78.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-23'}, {'value': '-86.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-18'}, {'value': '-81.0', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '15'}, {'value': '-70.1', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '20'}]}]}, {'title': 'EASI Score % Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-78.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '24'}, {'value': '-77.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-20'}, {'value': '-84.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '32'}, {'value': '-83.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-7'}, {'value': '-70.6', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '15'}]}]}, {'title': 'EASI Score % Change at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-80.8', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-12'}, {'value': '-81.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-31'}, {'value': '-87.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-86.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-14'}, {'value': '-74.5', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '-6'}]}]}, {'title': 'EASI Score % Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-82.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '10'}, {'value': '-82.7', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-31'}, {'value': '-90.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-56'}, {'value': '-87.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-36'}, {'value': '-82.4', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '-44'}]}]}, {'title': 'EASI Score % Change at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-83.6', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '16'}, {'value': '-80.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-23'}, {'value': '-91.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-52'}, {'value': '-87.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '4'}, {'value': '-81.8', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '-18'}]}]}, {'title': 'EASI Score % Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-84.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '7'}, {'value': '-83.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-24'}, {'value': '-93.0', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-62'}, {'value': '-87.2', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-39'}, {'value': '-82.2', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '5'}]}]}, {'title': 'EASI Score % Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-88.0', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-36'}, {'value': '-86.9', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-52'}, {'value': '-91.7', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-33'}, {'value': '-88.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-54'}, {'value': '-82.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}, {'title': 'EASI Score % Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-89.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-14'}, {'value': '-81.7', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '106'}, {'value': '-94.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-82'}, {'value': '-88.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-41'}, {'value': '-86.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}, {'title': 'EASI Score % Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-84.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-11'}, {'value': '-90.8', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-56'}, {'value': '-94.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-78'}, {'value': '-91.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-57'}, {'value': '-85.0', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '12'}]}]}, {'title': 'EASI Score % Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-90.4', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-42'}, {'value': '-92.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-56'}, {'value': '-93.2', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-66'}, {'value': '-92.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-58'}, {'value': '-90.2', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '-63'}]}]}, {'title': 'EASI Score % Change at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-87.4', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-32'}, {'value': '-88.3', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '-35'}, {'value': '-90.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-36'}, {'value': '-90.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-57'}, {'value': '-88.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '-50'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.', 'unitOfMeasure': 'percentage of score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'Achievement of EASI-50 at Week 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 6', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 8', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 10', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 12', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 14', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 15', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 16', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 18', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 20', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 22', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 24', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 26', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 28', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 30', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 32', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 34', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 36', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 40', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 44', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 48', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 52', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-50 at Week 56', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 8', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 10', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 12', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 14', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 15', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 16', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 18', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 20', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 22', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 24', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 26', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 28', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 30', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 32', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 34', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 36', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 40', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 44', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 48', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 52', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-75 at Week 56', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 6', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 8', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 10', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 12', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 14', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 15', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 16', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 18', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 20', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 22', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 24', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 26', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 28', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 30', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 32', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 34', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 36', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 40', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 44', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 48', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 52', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of EASI-90 at Week 56', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '56 Weeks', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'SCORAD Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '68.67', 'groupId': 'OG000', 'lowerLimit': '42.0', 'upperLimit': '96.3'}, {'value': '69.80', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '99.6'}, {'value': '68.19', 'groupId': 'OG002', 'lowerLimit': '42.1', 'upperLimit': '96.4'}, {'value': '68.79', 'groupId': 'OG003', 'lowerLimit': '40.1', 'upperLimit': '100.2'}, {'value': '66.35', 'groupId': 'OG004', 'lowerLimit': '38.7', 'upperLimit': '97.8'}]}]}, {'title': 'SCORAD Score at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '68.40', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '97.8'}, {'value': '66.53', 'groupId': 'OG001', 'lowerLimit': '34.5', 'upperLimit': '95.3'}, {'value': '63.06', 'groupId': 'OG002', 'lowerLimit': '28.5', 'upperLimit': '97.7'}, {'value': '64.99', 'groupId': 'OG003', 'lowerLimit': '22.5', 'upperLimit': '99.6'}, {'value': '62.83', 'groupId': 'OG004', 'lowerLimit': '26.2', 'upperLimit': '94.1'}]}]}, {'title': 'SCORAD Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '64.56', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '98.7'}, {'value': '62.75', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '96.8'}, {'value': '61.03', 'groupId': 'OG002', 'lowerLimit': '30.8', 'upperLimit': '97.1'}, {'value': '62.52', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '97.1'}, {'value': '65.31', 'groupId': 'OG004', 'lowerLimit': '28.1', 'upperLimit': '103.7'}]}]}, {'title': 'SCORAD Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '60.87', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '98.7'}, {'value': '59.84', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '99.9'}, {'value': '54.01', 'groupId': 'OG002', 'lowerLimit': '18.7', 'upperLimit': '95.3'}, {'value': '57.01', 'groupId': 'OG003', 'lowerLimit': '16.4', 'upperLimit': '99.0'}, {'value': '65.20', 'groupId': 'OG004', 'lowerLimit': '24.8', 'upperLimit': '98.2'}]}]}, {'title': 'SCORAD Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '56.59', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '101.5'}, {'value': '52.39', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '88.7'}, {'value': '46.32', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '82.9'}, {'value': '51.34', 'groupId': 'OG003', 'lowerLimit': '11.9', 'upperLimit': '93.6'}, {'value': '62.07', 'groupId': 'OG004', 'lowerLimit': '19.9', 'upperLimit': '99.2'}]}]}, {'title': 'SCORAD Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '48.46', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '101.4'}, {'value': '48.16', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '87.6'}, {'value': '45.05', 'groupId': 'OG002', 'lowerLimit': '16.8', 'upperLimit': '84.5'}, {'value': '48.29', 'groupId': 'OG003', 'lowerLimit': '10.2', 'upperLimit': '94.4'}, {'value': '59.11', 'groupId': 'OG004', 'lowerLimit': '26.0', 'upperLimit': '103.4'}]}]}, {'title': 'SCORAD Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '42.42', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '100.7'}, {'value': '45.15', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '85.7'}, {'value': '39.13', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '75.8'}, {'value': '45.50', 'groupId': 'OG003', 'lowerLimit': '9.4', 'upperLimit': '90.1'}, {'value': '58.85', 'groupId': 'OG004', 'lowerLimit': '20.3', 'upperLimit': '103.1'}]}]}, {'title': 'SCORAD Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '41.07', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '102.5'}, {'value': '41.98', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '84.9'}, {'value': '33.82', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '68.0'}, {'value': '43.68', 'groupId': 'OG003', 'lowerLimit': '9.7', 'upperLimit': '89.4'}, {'value': '57.15', 'groupId': 'OG004', 'lowerLimit': '15.3', 'upperLimit': '102.9'}]}]}, {'title': 'SCORAD Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.51', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '101.6'}, {'value': '39.75', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '88.9'}, {'value': '31.69', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '67.6'}, {'value': '39.41', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '88.1'}, {'value': '54.68', 'groupId': 'OG004', 'lowerLimit': '14.1', 'upperLimit': '96.4'}]}]}, {'title': 'SCORAD Score at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '35.79', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '93.7'}, {'value': '38.88', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '81.9'}, {'value': '30.03', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '76.9'}, {'value': '37.46', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '69.3'}, {'value': '51.66', 'groupId': 'OG004', 'lowerLimit': '16.7', 'upperLimit': '96.8'}]}]}, {'title': 'SCORAD Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '34.70', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '97.8'}, {'value': '37.82', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '77.8'}, {'value': '28.31', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '70.1'}, {'value': '35.76', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '72.4'}, {'value': '51.80', 'groupId': 'OG004', 'lowerLimit': '16.3', 'upperLimit': '97.0'}]}]}, {'title': 'SCORAD Score at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.44', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '97.8'}, {'value': '36.01', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '71.3'}, {'value': '30.14', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '64.5'}, {'value': '34.80', 'groupId': 'OG003', 'lowerLimit': '6.2', 'upperLimit': '83.8'}, {'value': '51.99', 'groupId': 'OG004', 'lowerLimit': '19.6', 'upperLimit': '97.6'}]}]}, {'title': 'SCORAD Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.88', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '100.3'}, {'value': '33.86', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '63.8'}, {'value': '27.59', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '66.4'}, {'value': '31.35', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '74.2'}, {'value': '48.17', 'groupId': 'OG004', 'lowerLimit': '13.0', 'upperLimit': '90.6'}]}]}, {'title': 'SCORAD Score at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '31.69', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '98.9'}, {'value': '30.13', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '59.4'}, {'value': '25.14', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '57.5'}, {'value': '28.21', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '64.0'}, {'value': '45.07', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '88.8'}]}]}, {'title': 'SCORAD Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '32.41', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '98.5'}, {'value': '29.06', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '57.0'}, {'value': '21.05', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '59.3'}, {'value': '29.93', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '93.8'}, {'value': '43.55', 'groupId': 'OG004', 'lowerLimit': '8.0', 'upperLimit': '90.8'}]}]}, {'title': 'SCORAD Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29.48', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '101.9'}, {'value': '27.54', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '56.5'}, {'value': '20.12', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '66.5'}, {'value': '28.31', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '93.0'}, {'value': '35.59', 'groupId': 'OG004', 'lowerLimit': '4.3', 'upperLimit': '80.6'}]}]}, {'title': 'SCORAD Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '29.21', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '102.7'}, {'value': '27.50', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '55.7'}, {'value': '20.23', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '68.0'}, {'value': '27.05', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '68.2'}, {'value': '32.88', 'groupId': 'OG004', 'lowerLimit': '11.3', 'upperLimit': '74.1'}]}]}, {'title': 'SCORAD Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25.75', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '79.2'}, {'value': '25.40', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '50.7'}, {'value': '18.05', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '59.2'}, {'value': '23.79', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '58.6'}, {'value': '33.63', 'groupId': 'OG004', 'lowerLimit': '10.9', 'upperLimit': '76.1'}]}]}, {'title': 'SCORAD Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25.09', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '102.2'}, {'value': '25.02', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '48.3'}, {'value': '16.29', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '48.0'}, {'value': '22.05', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '46.4'}, {'value': '29.23', 'groupId': 'OG004', 'lowerLimit': '8.8', 'upperLimit': '69.8'}]}]}, {'title': 'SCORAD Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24.63', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '102.4'}, {'value': '25.78', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '49.2'}, {'value': '15.65', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '40.9'}, {'value': '22.13', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '58.5'}, {'value': '27.55', 'groupId': 'OG004', 'lowerLimit': '6.6', 'upperLimit': '76.6'}]}]}, {'title': 'SCORAD Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23.82', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '93.8'}, {'value': '24.13', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '56.7'}, {'value': '15.46', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '39.2'}, {'value': '23.78', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '51.8'}, {'value': '26.86', 'groupId': 'OG004', 'lowerLimit': '10.3', 'upperLimit': '73.6'}]}]}, {'title': 'SCORAD Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.98', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '54.3'}, {'value': '21.49', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '46.6'}, {'value': '15.56', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '59.3'}, {'value': '24.14', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '48.0'}, {'value': '22.27', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '59.8'}]}]}, {'title': 'SCORAD Score at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.33', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '66.5'}, {'value': '21.86', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '92.8'}, {'value': '11.64', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '34.8'}, {'value': '20.08', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '52.0'}, {'value': '17.72', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '61.8'}]}]}, {'title': 'SCORAD Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25.83', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '67.3'}, {'value': '17.78', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '45.0'}, {'value': '11.90', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '40.2'}, {'value': '18.54', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '39.1'}, {'value': '17.54', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '62.2'}]}]}, {'title': 'SCORAD Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.96', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '42.5'}, {'value': '16.60', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '62.6'}, {'value': '15.02', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '66.3'}, {'value': '20.46', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '47.4'}, {'value': '15.21', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '37.3'}]}]}, {'title': 'SCORAD Score at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.65', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '60.3'}, {'value': '18.50', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '76.0'}, {'value': '11.92', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '61.1'}, {'value': '19.27', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '43.3'}, {'value': '16.91', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '34.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '56 Weeks', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'SCORAD Score % Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'groupId': 'OG000', 'lowerLimit': '-35.6', 'upperLimit': '50.0'}, {'value': '-4.08', 'groupId': 'OG001', 'lowerLimit': '-42.9', 'upperLimit': '19.7'}, {'value': '-7.03', 'groupId': 'OG002', 'lowerLimit': '-58.3', 'upperLimit': '36.1'}, {'value': '-5.75', 'groupId': 'OG003', 'lowerLimit': '-50.6', 'upperLimit': '27.7'}, {'value': '-4.54', 'groupId': 'OG004', 'lowerLimit': '-38.8', 'upperLimit': '20.3'}]}]}, {'title': 'SCORAD Score % Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-7.37', 'groupId': 'OG000', 'lowerLimit': '-52.7', 'upperLimit': '31.7'}, {'value': '-9.14', 'groupId': 'OG001', 'lowerLimit': '-61.8', 'upperLimit': '35.2'}, {'value': '-9.05', 'groupId': 'OG002', 'lowerLimit': '-53.4', 'upperLimit': '18.2'}, {'value': '-10.37', 'groupId': 'OG003', 'lowerLimit': '-95.9', 'upperLimit': '32.8'}, {'value': '-0.47', 'groupId': 'OG004', 'lowerLimit': '-34.8', 'upperLimit': '45.0'}]}]}, {'title': 'SCORAD Score % Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-13.51', 'groupId': 'OG000', 'lowerLimit': '-76.4', 'upperLimit': '41.0'}, {'value': '-12.97', 'groupId': 'OG001', 'lowerLimit': '-54.0', 'upperLimit': '36.2'}, {'value': '-19.60', 'groupId': 'OG002', 'lowerLimit': '-72.2', 'upperLimit': '39.5'}, {'value': '-15.77', 'groupId': 'OG003', 'lowerLimit': '-79.7', 'upperLimit': '40.0'}, {'value': '-1.98', 'groupId': 'OG004', 'lowerLimit': '-42.1', 'upperLimit': '41.9'}]}]}, {'title': 'SCORAD Score % Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-19.34', 'groupId': 'OG000', 'lowerLimit': '-98.0', 'upperLimit': '45.0'}, {'value': '-23.76', 'groupId': 'OG001', 'lowerLimit': '-86.1', 'upperLimit': '20.3'}, {'value': '-30.52', 'groupId': 'OG002', 'lowerLimit': '-73.0', 'upperLimit': '15.5'}, {'value': '-29.34', 'groupId': 'OG003', 'lowerLimit': '-85.3', 'upperLimit': '28.5'}, {'value': '-12.34', 'groupId': 'OG004', 'lowerLimit': '-53.5', 'upperLimit': '74.8'}]}]}, {'title': 'SCORAD Score % Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-31.63', 'groupId': 'OG000', 'lowerLimit': '-97.8', 'upperLimit': '44.9'}, {'value': '-29.29', 'groupId': 'OG001', 'lowerLimit': '-89.6', 'upperLimit': '28.1'}, {'value': '-32.82', 'groupId': 'OG002', 'lowerLimit': '-73.0', 'upperLimit': '15.5'}, {'value': '-29.34', 'groupId': 'OG003', 'lowerLimit': '-85.3', 'upperLimit': '28.5'}, {'value': '-12.34', 'groupId': 'OG004', 'lowerLimit': '-53.5', 'upperLimit': '74.8'}]}]}, {'title': 'SCORAD Score % Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-39.55', 'groupId': 'OG000', 'lowerLimit': '-98.7', 'upperLimit': '13.7'}, {'value': '-34.22', 'groupId': 'OG001', 'lowerLimit': '-89.7', 'upperLimit': '28.1'}, {'value': '-42.53', 'groupId': 'OG002', 'lowerLimit': '-99.1', 'upperLimit': '-0.5'}, {'value': '-34.32', 'groupId': 'OG003', 'lowerLimit': '-86.5', 'upperLimit': '4.6'}, {'value': '-13.14', 'groupId': 'OG004', 'lowerLimit': '-63.7', 'upperLimit': '21.3'}]}]}, {'title': 'SCORAD Score % Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-41.68', 'groupId': 'OG000', 'lowerLimit': '-97.1', 'upperLimit': '11.0'}, {'value': '-38.06', 'groupId': 'OG001', 'lowerLimit': '-88.9', 'upperLimit': '17.1'}, {'value': '-49.86', 'groupId': 'OG002', 'lowerLimit': '-95.1', 'upperLimit': '0.9'}, {'value': '-35.85', 'groupId': 'OG003', 'lowerLimit': '-86.1', 'upperLimit': '7.0'}, {'value': '-15.56', 'groupId': 'OG004', 'lowerLimit': '-72.6', 'upperLimit': '13.8'}]}]}, {'title': 'SCORAD Score % Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-44.39', 'groupId': 'OG000', 'lowerLimit': '-97.3', 'upperLimit': '7.9'}, {'value': '-41.69', 'groupId': 'OG001', 'lowerLimit': '-83.8', 'upperLimit': '18.2'}, {'value': '-53.03', 'groupId': 'OG002', 'lowerLimit': '-95.4', 'upperLimit': '7.4'}, {'value': '-42.09', 'groupId': 'OG003', 'lowerLimit': '-98.7', 'upperLimit': '16.3'}, {'value': '-19.05', 'groupId': 'OG004', 'lowerLimit': '-74.8', 'upperLimit': '24.7'}]}]}, {'title': 'SCORAD Score % Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-48.84', 'groupId': 'OG000', 'lowerLimit': '-98.9', 'upperLimit': '-0.8'}, {'value': '-42.54', 'groupId': 'OG001', 'lowerLimit': '-96.2', 'upperLimit': '11.5'}, {'value': '-55.95', 'groupId': 'OG002', 'lowerLimit': '-99.3', 'upperLimit': '-7.4'}, {'value': '-44.36', 'groupId': 'OG003', 'lowerLimit': '-98.8', 'upperLimit': '8.5'}, {'value': '-23.19', 'groupId': 'OG004', 'lowerLimit': '-70.1', 'upperLimit': '40.4'}]}]}, {'title': 'SCORAD Score % Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-50.07', 'groupId': 'OG000', 'lowerLimit': '-98.5', 'upperLimit': '3.5'}, {'value': '-43.47', 'groupId': 'OG001', 'lowerLimit': '-96.7', 'upperLimit': '18.9'}, {'value': '-58.24', 'groupId': 'OG002', 'lowerLimit': '-95.8', 'upperLimit': '-13.9'}, {'value': '-47.00', 'groupId': 'OG003', 'lowerLimit': '-98.5', 'upperLimit': '12.1'}, {'value': '-23.26', 'groupId': 'OG004', 'lowerLimit': '-71.7', 'upperLimit': '42.9'}]}]}, {'title': 'SCORAD Score % Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-47.48', 'groupId': 'OG000', 'lowerLimit': '-99.2', 'upperLimit': '7.1'}, {'value': '-46.42', 'groupId': 'OG001', 'lowerLimit': '-97.7', 'upperLimit': '20.8'}, {'value': '-56.06', 'groupId': 'OG002', 'lowerLimit': '-99.5', 'upperLimit': '-5.0'}, {'value': '-48.32', 'groupId': 'OG003', 'lowerLimit': '-91.8', 'upperLimit': '79.0'}, {'value': '-21.87', 'groupId': 'OG004', 'lowerLimit': '-80.0', 'upperLimit': '69.0'}]}]}, {'title': 'SCORAD Score % Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-51.55', 'groupId': 'OG000', 'lowerLimit': '-99.4', 'upperLimit': '10.0'}, {'value': '-49.39', 'groupId': 'OG001', 'lowerLimit': '-97.9', 'upperLimit': '17.8'}, {'value': '-58.91', 'groupId': 'OG002', 'lowerLimit': '-99.7', 'upperLimit': '-2.8'}, {'value': '-54.95', 'groupId': 'OG003', 'lowerLimit': '-99.7', 'upperLimit': '9.6'}, {'value': '-27.64', 'groupId': 'OG004', 'lowerLimit': '-85.7', 'upperLimit': '76.6'}]}]}, {'title': 'SCORAD Score % Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-54.91', 'groupId': 'OG000', 'lowerLimit': '-99.4', 'upperLimit': '13.3'}, {'value': '-55.22', 'groupId': 'OG001', 'lowerLimit': '-99.8', 'upperLimit': '26.9'}, {'value': '-62.02', 'groupId': 'OG002', 'lowerLimit': '-99.7', 'upperLimit': '-10.4'}, {'value': '-58.18', 'groupId': 'OG003', 'lowerLimit': '-99.7', 'upperLimit': '-0.9'}, {'value': '-32.18', 'groupId': 'OG004', 'lowerLimit': '-99.4', 'upperLimit': '73.1'}]}]}, {'title': 'SCORAD Score % Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-53.96', 'groupId': 'OG000', 'lowerLimit': '-99.2', 'upperLimit': '13.6'}, {'value': '-56.56', 'groupId': 'OG001', 'lowerLimit': '-99.8', 'upperLimit': '2.3'}, {'value': '-68.56', 'groupId': 'OG002', 'lowerLimit': '-99.7', 'upperLimit': '-3.4'}, {'value': '-56.63', 'groupId': 'OG003', 'lowerLimit': '-99.7', 'upperLimit': '5.7'}, {'value': '-34.10', 'groupId': 'OG004', 'lowerLimit': '-86.3', 'upperLimit': '77.0'}]}]}, {'title': 'SCORAD Score % Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-58.23', 'groupId': 'OG000', 'lowerLimit': '-99.4', 'upperLimit': '7.8'}, {'value': '-59.24', 'groupId': 'OG001', 'lowerLimit': '-99.5', 'upperLimit': '-13.5'}, {'value': '-68.82', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-3.5'}, {'value': '-58.19', 'groupId': 'OG003', 'lowerLimit': '-99.7', 'upperLimit': '4.8'}, {'value': '-47.60', 'groupId': 'OG004', 'lowerLimit': '-92.6', 'upperLimit': '18.8'}]}]}, {'title': 'SCORAD Score % Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-58.86', 'groupId': 'OG000', 'lowerLimit': '-99.6', 'upperLimit': '8.7'}, {'value': '-58.76', 'groupId': 'OG001', 'lowerLimit': '-97.2', 'upperLimit': '-12.0'}, {'value': '-68.19', 'groupId': 'OG002', 'lowerLimit': '-99.8', 'upperLimit': '-1.3'}, {'value': '-59.99', 'groupId': 'OG003', 'lowerLimit': '-99.7', 'upperLimit': '8.9'}, {'value': '-50.43', 'groupId': 'OG004', 'lowerLimit': '-81.0', 'upperLimit': '5.9'}]}]}, {'title': 'SCORAD Score % Change at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-63.35', 'groupId': 'OG000', 'lowerLimit': '-99.6', 'upperLimit': '-8.1'}, {'value': '-62.81', 'groupId': 'OG001', 'lowerLimit': '-99.5', 'upperLimit': '-30.2'}, {'value': '-72.05', 'groupId': 'OG002', 'lowerLimit': '-99.7', 'upperLimit': '-7.8'}, {'value': '-64.57', 'groupId': 'OG003', 'lowerLimit': '-99.7', 'upperLimit': '-20.2'}, {'value': '-49.89', 'groupId': 'OG004', 'lowerLimit': '-76.6', 'upperLimit': '14.6'}]}]}, {'title': 'SCORAD Score % Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-64.78', 'groupId': 'OG000', 'lowerLimit': '-99.6', 'upperLimit': '8.1'}, {'value': '-62.61', 'groupId': 'OG001', 'lowerLimit': '-99.7', 'upperLimit': '-24.5'}, {'value': '-74.40', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-14.9'}, {'value': '-67.09', 'groupId': 'OG003', 'lowerLimit': '-99.9', 'upperLimit': '-27.5'}, {'value': '-57.60', 'groupId': 'OG004', 'lowerLimit': '-87.5', 'upperLimit': '-14.6'}]}]}, {'title': 'SCORAD Score % Change at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-64.71', 'groupId': 'OG000', 'lowerLimit': '-99.6', 'upperLimit': '8.4'}, {'value': '-61.29', 'groupId': 'OG001', 'lowerLimit': '-99.3', 'upperLimit': '7.5'}, {'value': '-75.43', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-31.5'}, {'value': '-66.43', 'groupId': 'OG003', 'lowerLimit': '-99.3', 'upperLimit': '-10.7'}, {'value': '-59.75', 'groupId': 'OG004', 'lowerLimit': '-92.3', 'upperLimit': '8.7'}]}]}, {'title': 'SCORAD Score % Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-65.54', 'groupId': 'OG000', 'lowerLimit': '-99.7', 'upperLimit': '-0.7'}, {'value': '-63.75', 'groupId': 'OG001', 'lowerLimit': '-99.6', 'upperLimit': '29.5'}, {'value': '-75.38', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-22.5'}, {'value': '-64.60', 'groupId': 'OG003', 'lowerLimit': '-99.5', 'upperLimit': '-22.9'}, {'value': '-60.63', 'groupId': 'OG004', 'lowerLimit': '-87.3', 'upperLimit': '-1.8'}]}]}, {'title': 'SCORAD Score % Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-69.85', 'groupId': 'OG000', 'lowerLimit': '-99.8', 'upperLimit': '-13.5'}, {'value': '-66.90', 'groupId': 'OG001', 'lowerLimit': '-99.5', 'upperLimit': '6.4'}, {'value': '-75.95', 'groupId': 'OG002', 'lowerLimit': '-99.8', 'upperLimit': '-7.6'}, {'value': '-64.59', 'groupId': 'OG003', 'lowerLimit': '-98.5', 'upperLimit': '-30.0'}, {'value': '-66.66', 'groupId': 'OG004', 'lowerLimit': '-99.5', 'upperLimit': '-19.4'}]}]}, {'title': 'SCORAD Score % Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-74.31', 'groupId': 'OG000', 'lowerLimit': '-99.6', 'upperLimit': '-3.5'}, {'value': '-67.86', 'groupId': 'OG001', 'lowerLimit': '-99.5', 'upperLimit': '39.3'}, {'value': '-80.96', 'groupId': 'OG002', 'lowerLimit': '-99.9', 'upperLimit': '-31.2'}, {'value': '-70.81', 'groupId': 'OG003', 'lowerLimit': '-99.8', 'upperLimit': '-18.2'}, {'value': '-71.50', 'groupId': 'OG004', 'lowerLimit': '-99.4', 'upperLimit': '3.2'}]}]}, {'title': 'SCORAD Score % Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-64.22', 'groupId': 'OG000', 'lowerLimit': '-99.8', 'upperLimit': '-4.5'}, {'value': '-74.60', 'groupId': 'OG001', 'lowerLimit': '-99.8', 'upperLimit': '-34.0'}, {'value': '-81.00', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-20.6'}, {'value': '-74.06', 'groupId': 'OG003', 'lowerLimit': '-99.9', 'upperLimit': '-39.9'}, {'value': '-71.99', 'groupId': 'OG004', 'lowerLimit': '-99.2', 'upperLimit': '3.8'}]}]}, {'title': 'SCORAD Score % Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-70.53', 'groupId': 'OG000', 'lowerLimit': '-99.4', 'upperLimit': '-23.1'}, {'value': '-76.82', 'groupId': 'OG001', 'lowerLimit': '-100.0', 'upperLimit': '-16.8'}, {'value': '-77.96', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-12.0'}, {'value': '-71.47', 'groupId': 'OG003', 'lowerLimit': '-99.9', 'upperLimit': '-38.1'}, {'value': '-76.93', 'groupId': 'OG004', 'lowerLimit': '-99.6', 'upperLimit': '-39.9'}]}]}, {'title': 'SCORAD Score % Change at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-70.50', 'groupId': 'OG000', 'lowerLimit': '-99.1', 'upperLimit': '-24.8'}, {'value': '-74.01', 'groupId': 'OG001', 'lowerLimit': '-99.7', 'upperLimit': '1.1'}, {'value': '-80.81', 'groupId': 'OG002', 'lowerLimit': '-100.0', 'upperLimit': '-7.3'}, {'value': '-71.83', 'groupId': 'OG003', 'lowerLimit': '-99.9', 'upperLimit': '-35.2'}, {'value': '-74.51', 'groupId': 'OG004', 'lowerLimit': '-99.3', 'upperLimit': '-39.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.', 'unitOfMeasure': 'percentage of score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': "Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point", 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'Achievement of IGA Score at Week 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 6', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 10', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 12', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 14', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 15', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 16', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 18', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 20', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 22', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 24', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 26', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 28', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 30', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 32', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 34', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 36', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 40', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 44', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 48', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 52', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Achievement of IGA Score at Week 56', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '56 Weeks', 'description': 'In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'Change in % BSA at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-25', 'upperLimit': '17'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-25', 'upperLimit': '23'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-35', 'upperLimit': '40'}, {'value': '-0.1', 'groupId': 'OG003', 'lowerLimit': '-23', 'upperLimit': '23'}, {'value': '-1.2', 'groupId': 'OG004', 'lowerLimit': '-35', 'upperLimit': '45'}]}]}, {'title': 'Change in % BSA at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-42', 'upperLimit': '20'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-48', 'upperLimit': '15'}, {'value': '-6.4', 'groupId': 'OG002', 'lowerLimit': '-45', 'upperLimit': '25'}, {'value': '-1.9', 'groupId': 'OG003', 'lowerLimit': '-24', 'upperLimit': '38'}, {'value': '0.1', 'groupId': 'OG004', 'lowerLimit': '-38', 'upperLimit': '50'}]}]}, {'title': 'Change in % BSA at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'groupId': 'OG000', 'lowerLimit': '-60', 'upperLimit': '35'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-48', 'upperLimit': '39'}, {'value': '-10.7', 'groupId': 'OG002', 'lowerLimit': '-63', 'upperLimit': '25'}, {'value': '-5.6', 'groupId': 'OG003', 'lowerLimit': '-49', 'upperLimit': '23'}, {'value': '-2.2', 'groupId': 'OG004', 'lowerLimit': '-27', 'upperLimit': '20'}]}]}, {'title': 'Change in % BSA at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-13.7', 'groupId': 'OG000', 'lowerLimit': '-60', 'upperLimit': '30'}, {'value': '-11.2', 'groupId': 'OG001', 'lowerLimit': '-63', 'upperLimit': '22'}, {'value': '-16.9', 'groupId': 'OG002', 'lowerLimit': '-68', 'upperLimit': '25'}, {'value': '-12.1', 'groupId': 'OG003', 'lowerLimit': '-55', 'upperLimit': '42'}, {'value': '-4.0', 'groupId': 'OG004', 'lowerLimit': '-35', 'upperLimit': '20'}]}]}, {'title': 'Change in % BSA at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-18.6', 'groupId': 'OG000', 'lowerLimit': '-70', 'upperLimit': '32'}, {'value': '-19.3', 'groupId': 'OG001', 'lowerLimit': '-76', 'upperLimit': '6'}, {'value': '-21.4', 'groupId': 'OG002', 'lowerLimit': '-73', 'upperLimit': '25'}, {'value': '-17.2', 'groupId': 'OG003', 'lowerLimit': '-55', 'upperLimit': '25'}, {'value': '-4.4', 'groupId': 'OG004', 'lowerLimit': '-33', 'upperLimit': '40'}]}]}, {'title': 'Change in % BSA at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-24.5', 'groupId': 'OG000', 'lowerLimit': '-71', 'upperLimit': '39'}, {'value': '-22.6', 'groupId': 'OG001', 'lowerLimit': '-68', 'upperLimit': '3'}, {'value': '-26.0', 'groupId': 'OG002', 'lowerLimit': '-73', 'upperLimit': '25'}, {'value': '-20.7', 'groupId': 'OG003', 'lowerLimit': '-65', 'upperLimit': '19'}, {'value': '-4.8', 'groupId': 'OG004', 'lowerLimit': '-35', 'upperLimit': '20'}]}]}, {'title': 'Change in % BSA at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-27.4', 'groupId': 'OG000', 'lowerLimit': '-75', 'upperLimit': '39'}, {'value': '-26.4', 'groupId': 'OG001', 'lowerLimit': '-73', 'upperLimit': '5'}, {'value': '-31.1', 'groupId': 'OG002', 'lowerLimit': '-77', 'upperLimit': '25'}, {'value': '-22.2', 'groupId': 'OG003', 'lowerLimit': '-72', 'upperLimit': '22'}, {'value': '-4.9', 'groupId': 'OG004', 'lowerLimit': '-35', 'upperLimit': '20'}]}]}, {'title': 'Change in % BSA at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-29.8', 'groupId': 'OG000', 'lowerLimit': '-75', 'upperLimit': '35'}, {'value': '-29.4', 'groupId': 'OG001', 'lowerLimit': '-88', 'upperLimit': '3'}, {'value': '-33.6', 'groupId': 'OG002', 'lowerLimit': '-77', 'upperLimit': '28'}, {'value': '-24.4', 'groupId': 'OG003', 'lowerLimit': '-75', 'upperLimit': '22'}, {'value': '-10.2', 'groupId': 'OG004', 'lowerLimit': '-61', 'upperLimit': '13'}]}]}, {'title': 'Change in % BSA at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-31.9', 'groupId': 'OG000', 'lowerLimit': '-75', 'upperLimit': '24'}, {'value': '-29.3', 'groupId': 'OG001', 'lowerLimit': '-79', 'upperLimit': '2'}, {'value': '-35.1', 'groupId': 'OG002', 'lowerLimit': '-81', 'upperLimit': '15'}, {'value': '-25.6', 'groupId': 'OG003', 'lowerLimit': '-75', 'upperLimit': '32'}, {'value': '-12.2', 'groupId': 'OG004', 'lowerLimit': '-61', 'upperLimit': '20'}]}]}, {'title': 'Change in % BSA at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-31.9', 'groupId': 'OG000', 'lowerLimit': '-75', 'upperLimit': '39'}, {'value': '-29.6', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '25'}, {'value': '-35.5', 'groupId': 'OG002', 'lowerLimit': '-78', 'upperLimit': '20'}, {'value': '-28.9', 'groupId': 'OG003', 'lowerLimit': '-80', 'upperLimit': '24'}, {'value': '-14.1', 'groupId': 'OG004', 'lowerLimit': '-60', 'upperLimit': '20'}]}]}, {'title': 'Change in % BSA at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-34.6', 'groupId': 'OG000', 'lowerLimit': '-80', 'upperLimit': '39'}, {'value': '-32.7', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '0'}, {'value': '-35.5', 'groupId': 'OG002', 'lowerLimit': '-75', 'upperLimit': '5'}, {'value': '-29.6', 'groupId': 'OG003', 'lowerLimit': '-86', 'upperLimit': '39'}, {'value': '-13.1', 'groupId': 'OG004', 'lowerLimit': '-60', 'upperLimit': '30'}]}]}, {'title': 'Change in % BSA at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-35.9', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '39'}, {'value': '-34.8', 'groupId': 'OG001', 'lowerLimit': '-84', 'upperLimit': '2'}, {'value': '-39.7', 'groupId': 'OG002', 'lowerLimit': '-70', 'upperLimit': '7'}, {'value': '-34.6', 'groupId': 'OG003', 'lowerLimit': '-86', 'upperLimit': '19'}, {'value': '-13.3', 'groupId': 'OG004', 'lowerLimit': '-70', 'upperLimit': '35'}]}]}, {'title': 'Change in % BSA at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-39.3', 'groupId': 'OG000', 'lowerLimit': '-94', 'upperLimit': '39'}, {'value': '-38.3', 'groupId': 'OG001', 'lowerLimit': '-84', 'upperLimit': '0'}, {'value': '-40.6', 'groupId': 'OG002', 'lowerLimit': '-77', 'upperLimit': '11'}, {'value': '-38.3', 'groupId': 'OG003', 'lowerLimit': '-80', 'upperLimit': '21'}, {'value': '-18.5', 'groupId': 'OG004', 'lowerLimit': '-95', 'upperLimit': '35'}]}]}, {'title': 'Change in % BSA at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-37.7', 'groupId': 'OG000', 'lowerLimit': '-91', 'upperLimit': '39'}, {'value': '-39.0', 'groupId': 'OG001', 'lowerLimit': '-79', 'upperLimit': '0'}, {'value': '-42.9', 'groupId': 'OG002', 'lowerLimit': '-75', 'upperLimit': '20'}, {'value': '-40.6', 'groupId': 'OG003', 'lowerLimit': '-80', 'upperLimit': '10'}, {'value': '-21.1', 'groupId': 'OG004', 'lowerLimit': '-75', 'upperLimit': '37'}]}]}, {'title': 'Change in % BSA at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-38.3', 'groupId': 'OG000', 'lowerLimit': '-85', 'upperLimit': '39'}, {'value': '-42.1', 'groupId': 'OG001', 'lowerLimit': '-81', 'upperLimit': '-5'}, {'value': '-46.4', 'groupId': 'OG002', 'lowerLimit': '-88', 'upperLimit': '-10'}, {'value': '-42.0', 'groupId': 'OG003', 'lowerLimit': '-82', 'upperLimit': '27'}, {'value': '-26.9', 'groupId': 'OG004', 'lowerLimit': '-80', 'upperLimit': '9'}]}]}, {'title': 'Change in % BSA at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-41.2', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '34'}, {'value': '-43.1', 'groupId': 'OG001', 'lowerLimit': '-83', 'upperLimit': '-5'}, {'value': '-45.8', 'groupId': 'OG002', 'lowerLimit': '-87', 'upperLimit': '3'}, {'value': '-42.8', 'groupId': 'OG003', 'lowerLimit': '-78', 'upperLimit': '37'}, {'value': '-29.6', 'groupId': 'OG004', 'lowerLimit': '-70', 'upperLimit': '7'}]}]}, {'title': 'Change in % BSA at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-41.4', 'groupId': 'OG000', 'lowerLimit': '-93', 'upperLimit': '19'}, {'value': '-45.5', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '-10'}, {'value': '-46.2', 'groupId': 'OG002', 'lowerLimit': '-87', 'upperLimit': '-5'}, {'value': '-47.2', 'groupId': 'OG003', 'lowerLimit': '-80', 'upperLimit': '-8'}, {'value': '-32.1', 'groupId': 'OG004', 'lowerLimit': '-70', 'upperLimit': '6'}]}]}, {'title': 'Change in % BSA at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-44.0', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '39'}, {'value': '-46.5', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '-7'}, {'value': '-48.3', 'groupId': 'OG002', 'lowerLimit': '-85', 'upperLimit': '-15'}, {'value': '-48.2', 'groupId': 'OG003', 'lowerLimit': '-84', 'upperLimit': '-3'}, {'value': '-39.6', 'groupId': 'OG004', 'lowerLimit': '-80', 'upperLimit': '-9'}]}]}, {'title': 'Change in % BSA at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-44.4', 'groupId': 'OG000', 'lowerLimit': '-92', 'upperLimit': '39'}, {'value': '-45.1', 'groupId': 'OG001', 'lowerLimit': '-94', 'upperLimit': '-2'}, {'value': '-50.7', 'groupId': 'OG002', 'lowerLimit': '-90', 'upperLimit': '-18'}, {'value': '-49.0', 'groupId': 'OG003', 'lowerLimit': '-80', 'upperLimit': '-3'}, {'value': '-41.2', 'groupId': 'OG004', 'lowerLimit': '-85', 'upperLimit': '-3'}]}]}, {'title': 'Change in % BSA at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-44.6', 'groupId': 'OG000', 'lowerLimit': '-93', 'upperLimit': '39'}, {'value': '-48.1', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '4'}, {'value': '-50.3', 'groupId': 'OG002', 'lowerLimit': '-92', 'upperLimit': '-17'}, {'value': '-48.0', 'groupId': 'OG003', 'lowerLimit': '-84', 'upperLimit': '-3'}, {'value': '-40.8', 'groupId': 'OG004', 'lowerLimit': '-95', 'upperLimit': '4'}]}]}, {'title': 'Change in % BSA at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-49.0', 'groupId': 'OG000', 'lowerLimit': '-95', 'upperLimit': '-5'}, {'value': '-50.6', 'groupId': 'OG001', 'lowerLimit': '-87', 'upperLimit': '-4'}, {'value': '-51.6', 'groupId': 'OG002', 'lowerLimit': '-92', 'upperLimit': '-18'}, {'value': '-51.1', 'groupId': 'OG003', 'lowerLimit': '-82', 'upperLimit': '-4'}, {'value': '-46.6', 'groupId': 'OG004', 'lowerLimit': '-99', 'upperLimit': '-1'}]}]}, {'title': 'Change in % BSA at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-50.8', 'groupId': 'OG000', 'lowerLimit': '-95', 'upperLimit': '-13'}, {'value': '-47.9', 'groupId': 'OG001', 'lowerLimit': '-88', 'upperLimit': '5'}, {'value': '-53.5', 'groupId': 'OG002', 'lowerLimit': '-90', 'upperLimit': '-18'}, {'value': '-50.8', 'groupId': 'OG003', 'lowerLimit': '-90', 'upperLimit': '4'}, {'value': '-47.5', 'groupId': 'OG004', 'lowerLimit': '-89', 'upperLimit': '-10'}]}]}, {'title': 'Change in % BSA at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-46.6', 'groupId': 'OG000', 'lowerLimit': '-87', 'upperLimit': '-12'}, {'value': '-52.7', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '-13'}, {'value': '-53.9', 'groupId': 'OG002', 'lowerLimit': '-90', 'upperLimit': '-18'}, {'value': '-53.7', 'groupId': 'OG003', 'lowerLimit': '-90', 'upperLimit': '-24'}, {'value': '-46.2', 'groupId': 'OG004', 'lowerLimit': '-90', 'upperLimit': '0'}]}]}, {'title': 'Change in % BSA at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-49.7', 'groupId': 'OG000', 'lowerLimit': '-87', 'upperLimit': '-20'}, {'value': '-51.9', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '-12'}, {'value': '-53.7', 'groupId': 'OG002', 'lowerLimit': '-90', 'upperLimit': '-18'}, {'value': '-55.8', 'groupId': 'OG003', 'lowerLimit': '-90', 'upperLimit': '-24'}, {'value': '-48.6', 'groupId': 'OG004', 'lowerLimit': '-90', 'upperLimit': '-9'}]}]}, {'title': 'Change in % BSA at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-45.6', 'groupId': 'OG000', 'lowerLimit': '-80', 'upperLimit': '-10'}, {'value': '-47.2', 'groupId': 'OG001', 'lowerLimit': '-89', 'upperLimit': '3'}, {'value': '-53.8', 'groupId': 'OG002', 'lowerLimit': '-90', 'upperLimit': '-18'}, {'value': '-58.6', 'groupId': 'OG003', 'lowerLimit': '-90', 'upperLimit': '-27'}, {'value': '-45.9', 'groupId': 'OG004', 'lowerLimit': '-85', 'upperLimit': '-6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': 'The Investigator will calculate the percentage (%) of the total body surface area affected by AD.', 'unitOfMeasure': 'percentage of total BSA involvement', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Pruritus Numerical Rating Scale (NRS) Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'Pruritis NRS Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '7.6', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '7.2', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '6.8', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '6.9', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '6.3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '6.8', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '6.2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '3', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '6.5', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '6.0', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.8', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.8', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.6', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.9', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '5.3', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '5.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Pruritis NRS Score at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.8', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Pruritis NRS Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.9', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Pruritis NRS Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Pruritis NRS Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Pruritis NRS Score at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Pruritis NRS Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Pruritis NRS Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Pruritis NRS Score at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.3', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'Pruritis NRS Score % Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-60', 'upperLimit': '167'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '-56', 'upperLimit': '250'}, {'value': '-3.4', 'groupId': 'OG002', 'lowerLimit': '-88', 'upperLimit': '100'}, {'value': '-12.2', 'groupId': 'OG003', 'lowerLimit': '-50', 'upperLimit': '33'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '-67', 'upperLimit': '300'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-12.2', 'groupId': 'OG000', 'lowerLimit': '-63', 'upperLimit': '67'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-50', 'upperLimit': '200'}, {'value': '-11.9', 'groupId': 'OG002', 'lowerLimit': '-78', 'upperLimit': '50'}, {'value': '-11.8', 'groupId': 'OG003', 'lowerLimit': '-89', 'upperLimit': '43'}, {'value': '12.9', 'groupId': 'OG004', 'lowerLimit': '-75', 'upperLimit': '300'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-16.8', 'groupId': 'OG000', 'lowerLimit': '-80', 'upperLimit': '80'}, {'value': '-8.3', 'groupId': 'OG001', 'lowerLimit': '-80', 'upperLimit': '250'}, {'value': '-18.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '133'}, {'value': '-17.3', 'groupId': 'OG003', 'lowerLimit': '-89', 'upperLimit': '43'}, {'value': '14.0', 'groupId': 'OG004', 'lowerLimit': '-63', 'upperLimit': '350'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-22.1', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '80'}, {'value': '-26.0', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '75'}, {'value': '-32.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-26.0', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '5.2', 'groupId': 'OG004', 'lowerLimit': '-71', 'upperLimit': '300'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-28.1', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '60'}, {'value': '-25.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-37.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-31.0', 'groupId': 'OG003', 'lowerLimit': '-89', 'upperLimit': '33'}, {'value': '-8.8', 'groupId': 'OG004', 'lowerLimit': '-88', 'upperLimit': '200'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-37.0', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '20'}, {'value': '-36.9', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '75'}, {'value': '-43.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-32.1', 'groupId': 'OG003', 'lowerLimit': '-88', 'upperLimit': '50'}, {'value': '-14.3', 'groupId': 'OG004', 'lowerLimit': '-89', 'upperLimit': '200'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-37.9', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '29'}, {'value': '-37.9', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '250'}, {'value': '-49.0', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '33'}, {'value': '-36.0', 'groupId': 'OG003', 'lowerLimit': '-90', 'upperLimit': '40'}, {'value': '-16.0', 'groupId': 'OG004', 'lowerLimit': '-89', 'upperLimit': '100'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-43.9', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '0'}, {'value': '-45.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-52.7', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-36.0', 'groupId': 'OG003', 'lowerLimit': '-90', 'upperLimit': '100'}, {'value': '-13.5', 'groupId': 'OG004', 'lowerLimit': '-88', 'upperLimit': '200'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-41.7', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '29'}, {'value': '-43.6', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '150'}, {'value': '-57.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-42.6', 'groupId': 'OG003', 'lowerLimit': '-90', 'upperLimit': '20'}, {'value': '-16.3', 'groupId': 'OG004', 'lowerLimit': '-89', 'upperLimit': '300'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-39.9', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '29'}, {'value': '-44.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-57.4', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-45.7', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '20'}, {'value': '-20.4', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '200'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-45.8', 'groupId': 'OG000', 'lowerLimit': '-89', 'upperLimit': '13'}, {'value': '-44.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '250'}, {'value': '-52.1', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-42.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-29.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '60'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-46.6', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '50'}, {'value': '-49.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '250'}, {'value': '-56.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-49.7', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '33'}, {'value': '-25.1', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '200'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-48.0', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '13'}, {'value': '-52.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '250'}, {'value': '-66.2', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-53.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-20.9', 'groupId': 'OG004', 'lowerLimit': '-90', 'upperLimit': '300'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-48.9', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '14'}, {'value': '-53.3', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '75'}, {'value': '-66.7', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-51.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '13'}, {'value': '-33.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '100'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-52.4', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '13'}, {'value': '-52.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-71.2', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-54.0', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '30'}, {'value': '-39.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '40'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-50.3', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '40'}, {'value': '-56.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-73.7', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-57.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-45.4', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '20'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-56.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '14'}, {'value': '-64.3', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-69.4', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '75'}, {'value': '-60.0', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '20'}, {'value': '-48.4', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '80'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-58.3', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '13'}, {'value': '-61.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-70.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-60.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '20'}, {'value': '-63.6', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-60.9', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '13'}, {'value': '-58.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-72.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-57.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '40'}, {'value': '-63.1', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '40'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-59.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-60.9', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '150'}, {'value': '-72.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-60.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '60'}, {'value': '-64.0', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '13'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-61.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-52.8', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '250'}, {'value': '-70.2', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-60.7', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-67.0', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-59.2', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-70.6', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-77.1', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-25'}, {'value': '-68.4', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-75.2', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '-29'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-56.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '-10'}, {'value': '-69.3', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-74.0', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-68.3', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-69.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '80'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-57.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-70.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-72.9', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '43'}, {'value': '-60.3', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-80.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '33'}]}]}, {'title': 'Pruritis NRS Score % Change at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-60.2', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-67.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '14'}, {'value': '-75.7', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-65.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '11'}, {'value': '-82.1', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '-50'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."', 'unitOfMeasure': 'percentage of score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'Sleep Disturbance NRS Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '5.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '4.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.7', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '4.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '2.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Sleep Disturbance NRS Score at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'Sleep Disturbance NRS Score % Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '-83', 'upperLimit': '300'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '500'}, {'value': '29.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '-15.7', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '80'}, {'value': '51.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '700'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-90', 'upperLimit': '350'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '600'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '350'}, {'value': '-6.7', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '167'}, {'value': '60.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '700'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '500'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '600'}, {'value': '-11.2', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '167'}, {'value': '49.6', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '600'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '-7.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '500'}, {'value': '-18.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '-25.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '167'}, {'value': '33.6', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '500'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-11.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '300'}, {'value': '-10.8', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '-27.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '-31.8', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '43'}, {'value': '13.5', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '500'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-29.8', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '300'}, {'value': '-31.9', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-41.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-36.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '60'}, {'value': '11.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '500'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-37.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-13.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '500'}, {'value': '-54.8', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '17'}, {'value': '-38.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '33'}, {'value': '4.5', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '500'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-34.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-38.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '-49.6', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-44.0', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '40'}, {'value': '14.5', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '600'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-41.9', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-28.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '300'}, {'value': '-60.9', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-46.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '13.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '500'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-38.4', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-10.9', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '600'}, {'value': '-63.4', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '67'}, {'value': '-48.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '0.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '600'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-42.2', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-48.7', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '300'}, {'value': '-66.9', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-38.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '300'}, {'value': '8.1', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '700'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-44.4', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-48.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '500'}, {'value': '-72.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-50.0', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '9.1', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '800'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-45.0', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-45.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '500'}, {'value': '-75.1', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-56.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '29'}, {'value': '-2.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '700'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-53.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-53.3', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-67.3', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-52.5', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '60'}, {'value': '-5.5', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '600'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-46.5', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-55.5', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '300'}, {'value': '-75.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-57.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '60'}, {'value': '-39.4', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '80'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-48.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-54.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-80.4', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-58.8', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '33'}, {'value': '-38.9', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '60'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-58.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '29'}, {'value': '-63.3', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '300'}, {'value': '-77.4', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '67'}, {'value': '-67.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '40'}, {'value': '-45.6', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '80'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-60.0', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-45.6', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '700'}, {'value': '-78.0', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-65.8', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-55.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '40'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-61.1', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-66.0', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-82.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-64.8', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '20'}, {'value': '-51.7', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '33'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-64.9', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '17'}, {'value': '-45.1', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '700'}, {'value': '-81.9', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '-25'}, {'value': '-64.7', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '20'}, {'value': '-56.2', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '20'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-71.6', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-50.7', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '400'}, {'value': '-81.0', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-67.8', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-57.2', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '60'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-65.7', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '25'}, {'value': '-71.4', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-88.5', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-79.6', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-14'}, {'value': '-65.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-60.0', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '33'}, {'value': '-70.2', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '100'}, {'value': '-84.9', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '33'}, {'value': '-78.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-25'}, {'value': '-74.4', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-73.2', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '17'}, {'value': '-87.0', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '14'}, {'value': '-61.9', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-71.1', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '-14'}, {'value': '-69.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}, {'title': 'Sleep Disturbance NRS Score % Change at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-65.9', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '50'}, {'value': '-69.7', 'groupId': 'OG001', 'lowerLimit': '-100', 'upperLimit': '200'}, {'value': '-82.2', 'groupId': 'OG002', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-75.9', 'groupId': 'OG003', 'lowerLimit': '-100', 'upperLimit': '0'}, {'value': '-71.3', 'groupId': 'OG004', 'lowerLimit': '-100', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).", 'unitOfMeasure': 'percentage of score change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index (DLQI) at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '57', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}, {'id': 'OG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.\n\nWeeks 40-56 visits are off-treatment.'}], 'classes': [{'title': 'DLQI Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '30'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '29'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '27'}, {'value': '13.8', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '27'}, {'value': '11.9', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '30'}]}]}, {'title': 'DLQI Score at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '29'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '29'}, {'value': '11.2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '27'}, {'value': '12.7', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '27'}, {'value': '12.2', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '30'}]}]}, {'title': 'DLQI Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '30'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '10.7', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '12.7', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '29'}, {'value': '12.3', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '27'}]}]}, {'title': 'DLQI Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '11.2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '13.3', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '30'}]}]}, {'title': 'DLQI Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '27'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '20'}, {'value': '9.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '10.7', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '30'}]}]}, {'title': 'DLQI Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '9.0', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '29'}, {'value': '11.4', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '29'}]}]}, {'title': 'DLQI Score at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '27'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '22'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '21'}, {'value': '8.3', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '10.6', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '26'}]}]}, {'title': 'DLQI Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '5.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '7.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '9.7', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '24'}]}]}, {'title': 'DLQI Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '7.2', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '23'}, {'value': '10.1', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '28'}]}]}, {'title': 'DLQI Score at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '25'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '10.3', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '28'}]}]}, {'title': 'DLQI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '6.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '9.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '27'}]}]}, {'title': 'DLQI Score at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '4.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '6.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '9.5', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '29'}]}]}, {'title': 'DLQI Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '27'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '5.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '8.8', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '23'}]}]}, {'title': 'DLQI Score at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '5.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '8.6', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'DLQI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '8.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '27'}]}]}, {'title': 'DLQI Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '7.5', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '27'}]}]}, {'title': 'DLQI Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '6.6', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '26'}]}]}, {'title': 'DLQI Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '6.9', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'DLQI Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '6.1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '26'}]}]}, {'title': 'DLQI Score at Week 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '3.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '4.9', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'DLQI Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'DLQI Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '3.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '24'}]}]}, {'title': 'DLQI Score at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '24'}]}]}, {'title': 'DLQI Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '19'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '17'}]}]}, {'title': 'DLQI Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '27'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '3.3', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '19'}]}]}, {'title': 'DLQI Score at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '15'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '22'}]}]}], 'paramType': 'MEAN', 'timeFrame': '56 Weeks', 'description': 'DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'FG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'FG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'FG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'FG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '57'}]}, {'type': 'Completed Treatment Period A', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'Completed Treatment Period B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Ineligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The screening period began in September 2018. A total of 61 sites in four countries (Canada, Germany, Japan, and the United States) screened 351 patients and enrolled 274. The screening period closed in September 2019.', 'preAssignmentDetails': 'In Treatment Period A, randomized subjects received either study drug or placebo for 18 weeks. In Treatment Period B, the patients randomized to the placebo arm received study drug for 18 weeks. There was no treatment change for patients randomized to study drug arms.\n\nOne subject who was randomized to the 600 mg Q4W group did not receive any study drug due to consent withdrawal before the start of the treatment. They are not included in baseline or any of the analysis sets.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}, {'value': '273', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'KHK4083 150 mg SC Q4W', 'description': 'Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'BG001', 'title': 'KHK4083 600 mg SC Q4W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.\n\nTo maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.'}, {'id': 'BG002', 'title': 'KHK4083 300 mg SC Q2W', 'description': 'Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'BG003', 'title': 'KHK4083 600 mg SC Q2W', 'description': 'Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'BG004', 'title': 'Placebo/KHK4083 600 mg', 'description': 'Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '255', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '67'}, {'value': '38.9', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '70'}, {'value': '37.5', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '77'}, {'value': '37.3', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '89'}, {'value': '38.7', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '69'}, {'value': '38.0', 'groupId': 'BG005', 'lowerLimit': '18', 'upperLimit': '89'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '113', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '160', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '263', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '175', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '159', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One subject who was randomized to the 600 mg Q4W group did not receive any study treatment due to consent withdrawal before the start of the treatment. They are not included in baseline or any of the analysis sets.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-11', 'size': 1286980, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-17T16:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'subcutaneous administration'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2021-02-02', 'completionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2018-10-09', 'dispFirstSubmitQcDate': '2022-05-13', 'resultsFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2018-10-09', 'dispFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-13', 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.'}], 'secondaryOutcomes': [{'measure': 'Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.'}, {'measure': 'Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.'}, {'measure': 'Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.'}, {'measure': 'Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.'}, {'measure': "Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16", 'timeFrame': 'Baseline to Week 16', 'description': 'In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).'}, {'measure': 'Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)', 'timeFrame': 'Baseline to Week 16', 'description': 'The Investigator will calculate the percentage (%) of the total body surface area affected by AD.'}, {'measure': 'Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."'}, {'measure': 'Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score', 'timeFrame': 'Baseline to Week 16', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."'}, {'measure': 'Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score', 'timeFrame': 'Baseline to Week 16', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10)."}, {'measure': 'Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score', 'timeFrame': 'Baseline to Week 16', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10)."}, {'measure': 'Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline to Week 16', 'description': 'DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.'}, {'measure': 'EASI Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.'}, {'measure': 'Percent Change From Baseline in EASI Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.'}, {'measure': 'Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).'}, {'measure': 'SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.'}, {'measure': 'Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.'}, {'measure': "Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point", 'timeFrame': '56 Weeks', 'description': 'In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)'}, {'measure': 'Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'The Investigator will calculate the percentage (%) of the total body surface area affected by AD.'}, {'measure': 'Pruritus Numerical Rating Scale (NRS) Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."'}, {'measure': 'Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."'}, {'measure': 'Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10)."}, {'measure': 'Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point', 'timeFrame': '56 Weeks', 'description': "Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10)."}, {'measure': 'Dermatology Life Quality Index (DLQI) at Each Time Point', 'timeFrame': '56 Weeks', 'description': 'DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AD', 'eczema', 'skin diseases', 'biologics'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '39532780', 'type': 'DERIVED', 'citation': 'Gooderham M, Guttman-Yassky E, Igawa K, Kabashima K, Esfandiari E, Rylands AJ, Williams A, Nixon A, Dent JE, Simpson E. Rocatinlimab Improves Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Double-Blind Placebo-Controlled Phase 2b Study. Dermatol Ther (Heidelb). 2024 Dec;14(12):3351-3366. doi: 10.1007/s13555-024-01303-z. Epub 2024 Nov 12.'}, {'pmid': '36509097', 'type': 'DERIVED', 'citation': 'Guttman-Yassky E, Simpson EL, Reich K, Kabashima K, Igawa K, Suzuki T, Mano H, Matsui T, Esfandiari E, Furue M. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study. Lancet. 2023 Jan 21;401(10372):204-214. doi: 10.1016/S0140-6736(22)02037-2. Epub 2022 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group study for subjects with moderate to severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily signed informed consent to participate in the study;\n* Chronic AD, according to American Academy of Dermatology Consensus Criteria or the local diagnostic criteria, that has been present for at least 1 year before screening;\n* EASI score ≥16 at screening and baseline;\n* IGA score ≥3 (moderate) at both screening and baseline;\n* BSA ≥10% at both screening and baseline;\n* Documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).\n\nExclusion Criteria:\n\n* Current or past history of clinically significant illness(es) deemed by the Investigator to be likely to affect the study conduct and assessments. Examples include, but are not limited to, clinically significant cardiovascular (e.g., New York Heart Association \\[NYHA\\] Class III or IV), uncontrolled diabetes (HbA1c ≥9%), liver (e.g., Child-Pugh class B or C), renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders;\n* Any of the following laboratory abnormalities at screening:\n\n * Serum creatinine: \\>1.5 mg/dL\n * AST or ALT: ≥2.5 times the upper limit of normal (ULN)\n * Neutrophil count: \\<1.5×10³/μL\n * Other laboratory abnormalities that may affect the completion or evaluation of the study, as judged by the Investigator;\n* Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma).'}, 'identificationModule': {'nctId': 'NCT03703102', 'briefTitle': 'Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (AD)', 'orgStudyIdInfo': {'id': '4083-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm A', 'description': 'Subcutaneous administration of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Subcutaneous administration of KHK4083 (dose level 1, dosing regimen 2)', 'interventionNames': ['Drug: KHK4083']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'Subcutaneous administration of KHK4083 (dose level 2, dosing regimen 1)', 'interventionNames': ['Drug: KHK4083']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'description': 'Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 1)', 'interventionNames': ['Drug: KHK4083']}, {'type': 'EXPERIMENTAL', 'label': 'Arm E', 'description': 'Subcutaneous administration of KHK4083 (dose level 3, dosing regimen 2)', 'interventionNames': ['Drug: KHK4083']}], 'interventions': [{'name': 'KHK4083', 'type': 'DRUG', 'description': 'Anti-OX40 Monoclonal Antibody KHK4083', 'armGroupLabels': ['Arm B', 'Arm C', 'Arm D', 'Arm E']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Kyowa Investigational Site US-19', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Kyowa Investigational Site US-17', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 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