Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-01 @ 1:51 AM
Study NCT ID:
NCT01986933
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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': 'D012871', 'term': 'Skin Diseases'}, {'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': 'C000612881', 'term': 'nemolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials@chugai-pharm.co.jp', 'title': 'Clinical trials information', 'organization': 'Chugai Pharmaceutical'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B), Safety Follow-up period', 'description': 'The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality.\n\nNote: The Safety population was used for the analysis. The Safety population included all patients who received at least one dose of Nemoliozumab.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Part A)', 'description': 'Data from Part A and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 27, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A)', 'description': 'Data from Part A and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 29, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A)', 'description': 'Data from Part A and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 23, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A)', 'description': 'Data from Part A and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 27, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W (Part A)', 'description': 'Data from Part A and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 25, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A, Part B and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 37, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A, Part B and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 35, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A, Part B and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 33, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)', 'description': 'Data from Part A, Part B and Safety Follow-up period were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 35, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 15}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 12}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Non-alcoholic steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.07', 'groupId': 'OG000', 'lowerLimit': '-29.94', 'upperLimit': '-10.21'}, {'value': '-41.46', 'groupId': 'OG001', 'lowerLimit': '-51.21', 'upperLimit': '-31.71'}, {'value': '-61.24', 'groupId': 'OG002', 'lowerLimit': '-71.13', 'upperLimit': '-51.35'}, {'value': '-60.46', 'groupId': 'OG003', 'lowerLimit': '-69.98', 'upperLimit': '-50.95'}]}]}], 'analyses': [{'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.39', 'ciLowerLimit': '-35.25', 'ciUpperLimit': '-7.53', 'pValueComment': 'Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.02', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.16', 'ciLowerLimit': '-55.17', 'ciUpperLimit': '-27.15', 'pValueComment': 'Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.39', 'ciLowerLimit': '-54.11', 'ciUpperLimit': '-26.67', 'pValueComment': 'Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline to Week 12', 'description': 'Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch).\n\nWhen condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).', 'unitOfMeasure': 'percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the intent to treat (ITT) population excluding some of the major protocol violators, patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.12', 'spread': '40.00', 'groupId': 'OG000'}, {'value': '-26.89', 'spread': '44.48', 'groupId': 'OG001'}, {'value': '-35.70', 'spread': '44.29', 'groupId': 'OG002'}, {'value': '-33.86', 'spread': '34.14', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.82', 'spread': '47.00', 'groupId': 'OG000'}, {'value': '-25.17', 'spread': '51.79', 'groupId': 'OG001'}, {'value': '-46.20', 'spread': '42.62', 'groupId': 'OG002'}, {'value': '-39.89', 'spread': '34.43', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-20.89', 'spread': '47.63', 'groupId': 'OG000'}, {'value': '-27.88', 'spread': '50.50', 'groupId': 'OG001'}, {'value': '-44.57', 'spread': '48.21', 'groupId': 'OG002'}, {'value': '-40.29', 'spread': '37.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG002', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25.47', 'spread': '42.41', 'groupId': 'OG000'}, {'value': '-32.11', 'spread': '43.70', 'groupId': 'OG001'}, {'value': '-32.48', 'spread': '34.02', 'groupId': 'OG002'}, {'value': '-25.43', 'spread': '35.58', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25.13', 'spread': '49.82', 'groupId': 'OG000'}, {'value': '-47.86', 'spread': '41.38', 'groupId': 'OG001'}, {'value': '-41.02', 'spread': '36.50', 'groupId': 'OG002'}, {'value': '-33.35', 'spread': '38.00', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-35.11', 'spread': '47.92', 'groupId': 'OG000'}, {'value': '-47.75', 'spread': '45.41', 'groupId': 'OG001'}, {'value': '-46.78', 'spread': '35.15', 'groupId': 'OG002'}, {'value': '-42.12', 'spread': '40.82', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-55.83', 'spread': '42.25', 'groupId': 'OG000'}, {'value': '-62.71', 'spread': '44.37', 'groupId': 'OG001'}, {'value': '-56.26', 'spread': '34.68', 'groupId': 'OG002'}, {'value': '-51.01', 'spread': '37.07', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-69.90', 'spread': '28.17', 'groupId': 'OG000'}, {'value': '-71.16', 'spread': '43.31', 'groupId': 'OG001'}, {'value': '-61.14', 'spread': '44.43', 'groupId': 'OG002'}, {'value': '-74.29', 'spread': '33.97', 'groupId': 'OG003'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-63.11', 'spread': '41.89', 'groupId': 'OG000'}, {'value': '-78.81', 'spread': '28.82', 'groupId': 'OG001'}, {'value': '-70.85', 'spread': '36.24', 'groupId': 'OG002'}, {'value': '-70.87', 'spread': '32.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-68.45', 'spread': '41.62', 'groupId': 'OG000'}, {'value': '-75.79', 'spread': '25.40', 'groupId': 'OG001'}, {'value': '-78.91', 'spread': '24.34', 'groupId': 'OG002'}, {'value': '-69.25', 'spread': '43.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.83', 'spread': '25.97', 'groupId': 'OG000'}, {'value': '-29.31', 'spread': '23.58', 'groupId': 'OG001'}, {'value': '-34.59', 'spread': '29.36', 'groupId': 'OG002'}, {'value': '-29.82', 'spread': '21.65', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-17.29', 'spread': '30.74', 'groupId': 'OG000'}, {'value': '-26.41', 'spread': '26.60', 'groupId': 'OG001'}, {'value': '-36.81', 'spread': '29.04', 'groupId': 'OG002'}, {'value': '-34.72', 'spread': '24.33', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.97', 'spread': '26.99', 'groupId': 'OG000'}, {'value': '-27.22', 'spread': '25.81', 'groupId': 'OG001'}, {'value': '-39.49', 'spread': '32.68', 'groupId': 'OG002'}, {'value': '-38.31', 'spread': '28.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \\[\\<25\\], moderate \\[25-50\\] or severe \\[\\>50\\]).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG002', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-27.73', 'spread': '23.92', 'groupId': 'OG000'}, {'value': '-30.30', 'spread': '30.39', 'groupId': 'OG001'}, {'value': '-28.20', 'spread': '22.65', 'groupId': 'OG002'}, {'value': '-25.31', 'spread': '22.68', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-29.05', 'spread': '27.17', 'groupId': 'OG000'}, {'value': '-36.16', 'spread': '28.60', 'groupId': 'OG001'}, {'value': '-37.52', 'spread': '23.34', 'groupId': 'OG002'}, {'value': '-31.81', 'spread': '28.42', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-36.35', 'spread': '22.24', 'groupId': 'OG000'}, {'value': '-42.22', 'spread': '30.72', 'groupId': 'OG001'}, {'value': '-42.60', 'spread': '27.12', 'groupId': 'OG002'}, {'value': '-41.85', 'spread': '20.79', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-48.73', 'spread': '27.64', 'groupId': 'OG000'}, {'value': '-58.15', 'spread': '28.15', 'groupId': 'OG001'}, {'value': '-52.00', 'spread': '24.97', 'groupId': 'OG002'}, {'value': '-49.97', 'spread': '24.99', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-55.82', 'spread': '24.21', 'groupId': 'OG000'}, {'value': '-59.20', 'spread': '28.61', 'groupId': 'OG001'}, {'value': '-53.82', 'spread': '29.98', 'groupId': 'OG002'}, {'value': '-66.15', 'spread': '24.43', 'groupId': 'OG003'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-55.08', 'spread': '24.22', 'groupId': 'OG000'}, {'value': '-64.02', 'spread': '24.24', 'groupId': 'OG001'}, {'value': '-63.26', 'spread': '25.04', 'groupId': 'OG002'}, {'value': '-61.03', 'spread': '24.27', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-56.55', 'spread': '28.25', 'groupId': 'OG000'}, {'value': '-64.02', 'spread': '27.72', 'groupId': 'OG001'}, {'value': '-66.61', 'spread': '19.90', 'groupId': 'OG002'}, {'value': '-63.07', 'spread': '27.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \\[\\<25\\], moderate \\[25-50\\] or severe \\[\\>50\\]).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.'}, {'type': 'SECONDARY', 'title': "Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '1.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '1.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.\n\nWhen the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).', 'unitOfMeasure': 'change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.'}, {'type': 'SECONDARY', 'title': "Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG002', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '1.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '1.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.\n\nWhen the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).', 'unitOfMeasure': 'change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A)', 'description': 'Data from Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.48', 'spread': '37.14', 'groupId': 'OG000'}, {'value': '-12.11', 'spread': '43.69', 'groupId': 'OG001'}, {'value': '-23.49', 'spread': '40.93', 'groupId': 'OG002'}, {'value': '-18.44', 'spread': '35.47', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.44', 'spread': '49.29', 'groupId': 'OG000'}, {'value': '-14.90', 'spread': '45.84', 'groupId': 'OG001'}, {'value': '-27.23', 'spread': '47.17', 'groupId': 'OG002'}, {'value': '-22.99', 'spread': '38.58', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.29', 'spread': '49.87', 'groupId': 'OG000'}, {'value': '-17.54', 'spread': '47.16', 'groupId': 'OG001'}, {'value': '-19.68', 'spread': '67.49', 'groupId': 'OG002'}, {'value': '-24.36', 'spread': '41.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.\n\nWhen the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the ITT population excluding some of the major protocol violators , patients who were withdrawn before being evaluated for pruritus VAS at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG001', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG002', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}, {'id': 'OG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W (Part A + Part B)', 'description': 'Data from Part A and Part B were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.\n\nActive-to-active period (Part B) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.12', 'spread': '45.56', 'groupId': 'OG000'}, {'value': '-23.28', 'spread': '38.96', 'groupId': 'OG001'}, {'value': '-17.98', 'spread': '35.12', 'groupId': 'OG002'}, {'value': '-2.79', 'spread': '54.12', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-18.08', 'spread': '45.82', 'groupId': 'OG000'}, {'value': '-29.58', 'spread': '47.13', 'groupId': 'OG001'}, {'value': '-24.64', 'spread': '37.49', 'groupId': 'OG002'}, {'value': '-6.66', 'spread': '59.40', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-24.53', 'spread': '49.77', 'groupId': 'OG000'}, {'value': '-25.31', 'spread': '63.43', 'groupId': 'OG001'}, {'value': '-25.91', 'spread': '44.40', 'groupId': 'OG002'}, {'value': '-18.56', 'spread': '52.30', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-48.13', 'spread': '39.07', 'groupId': 'OG000'}, {'value': '-51.41', 'spread': '44.10', 'groupId': 'OG001'}, {'value': '-40.53', 'spread': '42.94', 'groupId': 'OG002'}, {'value': '-36.91', 'spread': '40.99', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-65.21', 'spread': '32.63', 'groupId': 'OG000'}, {'value': '-69.20', 'spread': '39.95', 'groupId': 'OG001'}, {'value': '-49.66', 'spread': '44.18', 'groupId': 'OG002'}, {'value': '-59.97', 'spread': '50.32', 'groupId': 'OG003'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-60.41', 'spread': '37.00', 'groupId': 'OG000'}, {'value': '-70.44', 'spread': '35.81', 'groupId': 'OG001'}, {'value': '-60.99', 'spread': '48.00', 'groupId': 'OG002'}, {'value': '-58.38', 'spread': '44.97', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-62.54', 'spread': '40.92', 'groupId': 'OG000'}, {'value': '-66.01', 'spread': '36.38', 'groupId': 'OG001'}, {'value': '-63.35', 'spread': '40.37', 'groupId': 'OG002'}, {'value': '-60.54', 'spread': '55.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.\n\nWhen the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat (ITT) Long population was used for the analysis. The ITT Long population included patients randomized to Nemoliozumab treatment groups in Part A and patients re-randomized from the placebo group to Nemoliozumab treatment groups, providing they received at least one dose of Nemoliozumab and providing the results of at least one post-dose efficacy assessment was available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nPlacebo-to-active period (Part B ) (up to Week 64):\n\nPatients randomized to placebo group in Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B. Nemoliozumab was given subcutaneously every 4 weeks for 52 weeks. Placebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B.'}, {'id': 'FG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W', 'description': 'The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B ) (up to Week 64):\n\nPatients in the Nemoliozumab (0.1 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.\n\nPlacebo-to-active period (Part B) (up to Week 64):\n\nPatients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.'}, {'id': 'FG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W', 'description': 'The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B ) (up to Week 64):\n\nPatients in the Nemoliozumab (0.5 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.\n\nPlacebo-to-active period (Part B) (up to Week 64):\n\nPatients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.'}, {'id': 'FG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W', 'description': 'The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.\n\nActive-to-active period (Part B ) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q4W group during Part A continuously used the same regimen of Nemoliozumab in Part B.\n\nPlacebo-to-active period (Part B) (up to Week 64):\n\nPatients in the Placebo group during Part A were re-randomized to Nemoliozumab groups (0.1 mg/kg, 0.5 mg/kg or 2.0 mg/kg Q4W) in Part B.'}, {'id': 'FG004', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W', 'description': 'The study was undertaken in two parts, Part A and Part B. A Safety Follow-up visit was performed 12 weeks after the last dose of study drug.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.\n\nActive-to-active period (Part B ) (up to Week 64):\n\nPatients in the Nemoliozumab (2.0 mg/kg) Q8W group during Part A continuously used the same regimen of Nemoliozumab in Part B.\n\nPlacebo-to-active period (Part B) (up to Week 64):\n\nPlacebo-treated patients in Part A were not re-randomized to Nemoliozumab (2.0 mg/kg) Q8W group in Part B.'}], 'periods': [{'title': 'Placebo-controlled (Part A)', 'milestones': [{'type': 'STARTED', 'comment': 'Patients were randomly assigned (1:1:1:1:1 ratio) to one of four active treatment groups and one placebo group in double-blind fashion.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Others (not classified above reasons)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}, {'title': 'Active-to-active (Part B)', 'milestones': [{'type': 'STARTED', 'comment': 'Data from patients who were randomized to Nemoliozumab groups in Part A and initiated Part B were analyzed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '39'}, {'groupId': 'FG004', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Others (not classified above reasons)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Placebo-to-active (Part B)', 'milestones': [{'type': 'STARTED', 'comment': 'Data from patients who were randomized to placebo group in Part A and initiated Part B were analyzed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Patients in the initial placebo group were re-randomized into Nemoliozumab groups (0.1, 0.5 or 2.0 mg/kg Q4W) in Part B.', 'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Patients in the initial placebo group were re-randomized into Nemoliozumab groups (0.1, 0.5 or 2.0 mg/kg Q4W) in Part B.', 'groupId': 'FG002', 'numSubjects': '12'}, {'comment': 'Patients in the initial placebo group were re-randomized into Nemoliozumab groups (0.1, 0.5 or 2.0 mg/kg Q4W) in Part B.', 'groupId': 'FG003', 'numSubjects': '13'}, {'comment': 'Patients in the initial placebo group were not re-randomized into Nemoliozumab (2.0 mg/kg) Q8W group in Part B.', 'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The patients were enrolled at 57 investigational sites in the UK, Germany, Poland, Japan, and the US.', 'preAssignmentDetails': 'Patient eligibility was assessed during the screening period (Day -28 to Day -8). If all eligibility criteria were met, the patient entered a 7-day run-in period (Day -7 to Day -1) during which all prohibited treatments were discontinued. Baseline assessments were performed until randomization on Day 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '229', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (Part A)', 'description': 'Data from patients randomized to this group in Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received placebo subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'BG001', 'title': 'Nemoliozumab (0.1 mg/kg) Q4W (Part A)', 'description': 'Data from patients randomized to this group in Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.1 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'BG002', 'title': 'Nemoliozumab (0.5 mg/kg) Q4W (Part A)', 'description': 'Data from patients randomized to this group in Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (0.5 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'BG003', 'title': 'Nemoliozumab (2.0 mg/kg) Q4W (Part A)', 'description': 'Data from patients randomized to this group in Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 4 weeks on Day 1, Week 4 and Week 8.'}, {'id': 'BG004', 'title': 'Nemoliozumab (2.0 mg/kg) Q8W (Part A)', 'description': 'Data from patients randomized to this group in Part A were analyzed.\n\nPlacebo-controlled period (Part A) (Day 1 to Week 12):\n\nPatients randomized to this group received Nemoliozumab (2.0 mg/kg) subcutaneously every 8 weeks on Day 1 and Week 8.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '33.9', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '33.7', 'spread': '12.2', 'groupId': 'BG003'}, {'value': '34.6', 'spread': '13.3', 'groupId': 'BG004'}, {'value': '34.2', 'spread': '12.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Category', 'categories': [{'title': '< 20 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': '20 -< 30 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}]}, {'title': '30 -< 40 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}]}, {'title': '40 -< 50 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': '50 -< 60 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': '> 60 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '119', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '223', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', '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': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '70', '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': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '142', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '167.81', 'spread': '8.84', 'groupId': 'BG000'}, {'value': '170.19', 'spread': '10.52', 'groupId': 'BG001'}, {'value': '167.41', 'spread': '9.44', 'groupId': 'BG002'}, {'value': '170.04', 'spread': '8.84', 'groupId': 'BG003'}, {'value': '167.58', 'spread': '9.63', 'groupId': 'BG004'}, {'value': '168.62', 'spread': '9.47', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimetre', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.20', 'spread': '21.60', 'groupId': 'BG000'}, {'value': '76.01', 'spread': '22.90', 'groupId': 'BG001'}, {'value': '73.40', 'spread': '19.98', 'groupId': 'BG002'}, {'value': '72.51', 'spread': '16.04', 'groupId': 'BG003'}, {'value': '72.63', 'spread': '20.96', 'groupId': 'BG004'}, {'value': '73.75', 'spread': '20.27', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight Category', 'classes': [{'categories': [{'title': '< 60 kg', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}, {'title': '>- 60 kg', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '165', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '26.20', 'spread': '6.81', 'groupId': 'BG000'}, {'value': '25.92', 'spread': '6.41', 'groupId': 'BG001'}, {'value': '26.10', 'spread': '6.66', 'groupId': 'BG002'}, {'value': '25.08', 'spread': '5.26', 'groupId': 'BG003'}, {'value': '25.71', 'spread': '6.47', 'groupId': 'BG004'}, {'value': '25.80', 'spread': '6.30', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilogram per square metre', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index Category', 'classes': [{'categories': [{'title': '< 25 kg/m^2', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '127', 'groupId': 'BG005'}]}, {'title': '>- 25 kg/m^2', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '102', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The per-protocol (PP) population in Part A was used for the analysis. The PP population was defined as a subset of the intent to treat (ITT) population excluding some of the major protocol violators, patients who were withdrawn before being evaluated for pruritus Visual Analogue Scale (VAS) at Week 8, or those who withdrew prior to receiving two or more study drug administrations. Patients who received the wrong study drug were also excluded from the PP population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2013-10-31', 'resultsFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-22', 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12', 'timeFrame': 'baseline to Week 12', 'description': 'Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch).\n\nWhen condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves).'}], 'secondaryOutcomes': [{'measure': 'Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population)', 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).'}, {'measure': 'Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population)', 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).'}, {'measure': 'Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population)', 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \\[\\<25\\], moderate \\[25-50\\] or severe \\[\\>50\\]).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).'}, {'measure': 'Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population)', 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild \\[\\<25\\], moderate \\[25-50\\] or severe \\[\\>50\\]).\n\nWhen the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).'}, {'measure': "Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population)", 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.\n\nWhen the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).'}, {'measure': "Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population)", 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation.\n\nWhen the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves).'}, {'measure': 'Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population)', 'timeFrame': 'baseline to Week 12 (Part A)', 'description': 'The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.\n\nWhen the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).'}, {'measure': 'Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population)', 'timeFrame': 'baseline to Week 12 (Part A), up to Week 64 (Part B)', 'description': 'The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA.\n\nWhen the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '29753033', 'type': 'DERIVED', 'citation': 'Kabashima K, Furue M, Hanifin JM, Pulka G, Wollenberg A, Galus R, Etoh T, Mihara R, Nakano M, Ruzicka T. Nemolizumab in patients with moderate-to-severe atopic dermatitis: Randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121-1130.e7. doi: 10.1016/j.jaci.2018.03.018. Epub 2018 May 10.'}, {'pmid': '28249150', 'type': 'DERIVED', 'citation': 'Ruzicka T, Hanifin JM, Furue M, Pulka G, Mlynarczyk I, Wollenberg A, Galus R, Etoh T, Mihara R, Yoshida H, Stewart J, Kabashima K; XCIMA Study Group. Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis. N Engl J Med. 2017 Mar 2;376(9):826-835. doi: 10.1056/NEJMoa1606490.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥18 and ≤65 years of age at the time of consent.\n* Patients with Atopic Dermatitis\n* Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit\n* Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit\n* static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit\n\nExclusion Criteria:\n\n* Serological evidence of hepatitis B virus or hepatitis C virus infection\n* Known human immunodeficiency virus infection\n* Ongoing treatment with specific or non-specific hyposensitization therapy for AD\n* Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization\n* History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.\n* Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.\n* Pregnant or lactating women."}, 'identificationModule': {'nctId': 'NCT01986933', 'briefTitle': 'A Phase 2 Study of CIM331 for Atopic Dermatitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY', 'orgStudyIdInfo': {'id': 'CIM003JG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group1', 'description': 'Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)', 'interventionNames': ['Drug: nemolizumab (CIM331)']}, {'type': 'EXPERIMENTAL', 'label': 'Group2', 'description': 'Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)', 'interventionNames': ['Drug: nemolizumab (CIM331)']}, {'type': 'EXPERIMENTAL', 'label': 'Group3', 'description': 'Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)', 'interventionNames': ['Drug: nemolizumab (CIM331)']}, {'type': 'EXPERIMENTAL', 'label': 'Group4', 'description': 'Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)', 'interventionNames': ['Drug: nemolizumab (CIM331)']}, {'type': 'EXPERIMENTAL', 'label': 'Group5', 'description': 'Part A: Placebo Part B: nemolizumab (CIM331)', 'interventionNames': ['Drug: nemolizumab (CIM331)', 'Other: Placebo']}], 'interventions': [{'name': 'nemolizumab (CIM331)', 'type': 'DRUG', 'armGroupLabels': ['Group1', 'Group2', 'Group3', 'Group4', 'Group5']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Group5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33142', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28226', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77845', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Ryosuke Mihara', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chugai Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}