Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-26 @ 11:56 PM
Study NCT ID:
NCT05369403
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], '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': 'C561806', 'term': 'lebrikizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800- 545-5979', 'title': 'Chief Medical Officer', 'organization': 'Chief Medical Officer'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline Up To 24 Weeks AE data from the safety follow-up period and the continuous access period will be reported during the final results posting.', 'description': 'All enrolled participants who received at least one confirmed dose of 250 mg lebrikizumab.', 'eventGroups': [{'id': 'EG000', 'title': 'Lebrikizumab 250 mg Q2W', 'description': 'Participants received 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 38, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Lebrikizumab 250 mg Q2W to Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lebrikizumab 250 mg Q2W to Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 6, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Tooth impacted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Viral abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Immune-mediated dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Cerebral vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rash morbilliform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000', 'lowerLimit': '46.9', 'upperLimit': '67.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 75 data. Observed Cases (OC) analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EASI 75 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '51.8'}, {'value': '71.8', 'groupId': 'OG001', 'lowerLimit': '58.8', 'upperLimit': '81.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI 75 data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '49.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': "The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had Baseline IGA of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '31.6'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '36.1', 'upperLimit': '61.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': "The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 IGA score data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in EASI Total Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-73.3', 'spread': '23.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in EASI Score From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-64.6', 'spread': '23.26', 'groupId': 'OG000'}, {'value': '-82.4', 'spread': '15.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EASI Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.4', 'spread': '9.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EASI Score From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.4', 'spread': '8.90', 'groupId': 'OG000'}, {'value': '-19.0', 'spread': '8.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI score data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '39.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had Week 16 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving EASI-90 From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '31.6'}, {'value': '35.9', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '49.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had Week 24 EASI 90 data. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '64.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 4. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '73.9'}, {'value': '65.4', 'groupId': 'OG001', 'lowerLimit': '49.3', 'upperLimit': '78.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a \\>=4-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '82.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had a Baseline Pruritus NRS score of at least 3. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '90.4'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '88.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had a \\>=3-point improvement from baseline in week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.6', 'spread': '41.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had week 16 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.0', 'spread': '99.07', 'groupId': 'OG000'}, {'value': '-62.0', 'spread': '35.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 pruritus NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '26.8', 'upperLimit': '58.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had a baseline Sleep-Loss scale score of at least 2. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '72.8'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '24.1', 'upperLimit': '64.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had a \\>=2-point improvement from baseline in week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep-Loss Scale From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had week 16 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep-Loss Scale From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 Sleep-Loss scale score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Pain NRS From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '2.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had week 16 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Pain NRS From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 skin pain NRS score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.7', 'spread': '6.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The DLQI questionnaire designed for participants aged \\>=16 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had week 16 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in DLQI From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.5', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '5.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment over the previous week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively. Questions 3-10 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 DLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '7.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The CDLQI questionnaire designed for participants aged \\<16 years and It consists of 10 items that are grouped into 6 domains: symptoms \\& feelings, leisure, school or holidays, personal relationships, sleep, \\& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had week 16 CDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CDLQI From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Only 1 participant included in the analysis, therefore standard deviation is not calculable.', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '9.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The CDLQI questionnaire designed for participants aged \\<16 years and It consists of 10 items that are grouped into 6 domains: symptoms \\& feelings, leisure, school or holidays, personal relationships, sleep, \\& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 0 to 24 of the treatment period and had week 24 cDLQI score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.7', 'spread': '22.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7\\*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants according to their planned intervention and had week 16 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in SCORAD From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'OG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once Q4W until Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-47.4', 'spread': '27.07', 'groupId': 'OG000'}, {'value': '-60.1', 'spread': '23.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7\\*B/2 + C, ranging from 0 (no disease) to 103 (severe disease).', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the treatment period and had week 24 SCORAD score. OC analysis is applied here, where analysis is using all the observed data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lebrikizumab 250 mg Q2W', 'description': 'Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.'}, {'id': 'FG001', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}, {'id': 'FG002', 'title': 'Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W', 'description': 'Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24.'}], 'periods': [{'title': 'Treatment Period 1: Week 0 to Week 16', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Intent-to-Treat (ITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Participant enrolled but didn't meet inclusion criteria 11", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant enrolled but did not meet inclusion criteria 3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2: Weeks 16 to Week 24', 'milestones': [{'type': 'STARTED', 'comment': 'Treatment Period 2 Population: All enrolled patients who received at least 1 confirmed dose of 250 mg lebrikizumab during Weeks 16 to 24 of the Treatment Period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Results for maximum extended enrollment (ME2) participants will be posted after the study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lebrikizumab 250mg Q2W', 'description': 'Participants received a 500 mg loading dose of Lebrikizumab SC once Q2W at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16. Responders who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline at Week 16 received 250 mg SC once Q4W until Week 24. Inadequate responders at Week 16 continued to receive 250 mg SC once Q2W until Week 24.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.4', 'spread': '20.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The intent-to-treat (ITT) population included all enrolled participants according to their planned intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-27', 'size': 2210314, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-10T03:00', 'hasProtocol': True}, {'date': '2023-06-23', 'size': 1503901, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-10T03:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2022-05-06', 'resultsFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-01', 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75) at Week 16', 'timeFrame': 'Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving EASI 75 at Week 24', 'timeFrame': 'Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.'}, {'measure': "Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16", 'timeFrame': 'Baseline to Week 16', 'description': "The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point."}, {'measure': 'Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': "The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on the descriptors that best describe the overall appearance of the lesions at a given time point."}, {'measure': 'Percentage Change From Baseline in EASI Total Score From Baseline to Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).'}, {'measure': 'Percentage Change From Baseline in EASI Score From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).'}, {'measure': 'Change From Baseline in EASI Score From Baseline to Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).'}, {'measure': 'Change From Baseline in EASI Score From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).'}, {'measure': 'Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.'}, {'measure': 'Percentage of Participants Achieving EASI-90 From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 responder is defined as a ≥ 90% improvement from baseline in the EASI score.'}, {'measure': 'Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."'}, {'measure': 'Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."'}, {'measure': 'Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."'}, {'measure': 'Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."'}, {'measure': 'Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary.'}, {'measure': 'Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Assessments were recorded daily by the participant using an electronic diary.'}, {'measure': 'Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.'}, {'measure': 'Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.'}, {'measure': 'Change From Baseline in Sleep-Loss Scale From Baseline to Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.'}, {'measure': 'Change From Baseline in Sleep-Loss Scale From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Sleep loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \\[0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant.'}, {'measure': 'Change From Baseline in Skin Pain NRS From Baseline to Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."'}, {'measure': 'Change From Baseline in Skin Pain NRS From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The Skin Pain NRS is an 11-point scale used by participants to rate their worst level of skin pain over the past 24 hours, with 0 indicating "no pain" and 10 indicating "worst pain imaginable."'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The DLQI questionnaire designed for participants aged \\>=16 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.'}, {'measure': 'Change From Baseline in DLQI From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The DLQI questionnaire for participants aged 16 and above is a 10-item tool used to assess the impact of skin disease on quality of life. The 10 questions cover topics: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment over the previous week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively. Questions 3-10 have an additional response category of "not relevant," which is scored as "0." Questions are scored from 0 to 3. Total score ranges from 0 (no impact) to 30 (maximum impact), with higher scores indicating poorer quality of life.'}, {'measure': "Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16", 'timeFrame': 'Baseline, Week 16', 'description': 'The CDLQI questionnaire designed for participants aged \\<16 years and It consists of 10 items that are grouped into 6 domains: symptoms \\& feelings, leisure, school or holidays, personal relationships, sleep, \\& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).'}, {'measure': 'Change From Baseline in CDLQI From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The CDLQI questionnaire designed for participants aged \\<16 years and It consists of 10 items that are grouped into 6 domains: symptoms \\& feelings, leisure, school or holidays, personal relationships, sleep, \\& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).'}, {'measure': 'Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7\\*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease.'}, {'measure': 'Percentage Change From Baseline in SCORAD From Baseline to Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'SCORAD is a validated tool for assessing the extent and intensity of AD. It consists of three components: A) the extent of AD as a percentage of each body area, with a maximum score of 100%; B) the severity of six specific symptoms (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) rated from 0 (none) to 3 (severe) for a maximum of 18 points; and C) the subjective assessment of itch and sleeplessness on a visual analog scale (VAS) from 0 (no itch/sleeplessness) to 10 (worst imaginable itch/sleeplessness) with a maximum score of 20. The total SCORAD score is calculated as A/5 + 7\\*B/2 + C, ranging from 0 (no disease) to 103 (severe disease).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eczema'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/343315', 'label': 'A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants must have prior treatment with dupilumab meeting one of the following conditions:\n\n * Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.\n * Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.\n * Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.\n* Participants who have chronic AD that has been present for ≥1 year before screening.\n* Have EASI ≥16 at baseline\n* Have IGA score ≥3 (Scale of 0 to 4) at baseline\n* Have ≥10% body surface area (BSA) of AD involvement at baseline\n* Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.\n* Adolescents body weight must be ≥40 kg at baseline.\n\nExclusion Criteria:\n\n* History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.\n* Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA\n* Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA\n* Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.\n* Have uncontrolled asthma that\n\n * might require bursts of oral or systemic corticosteroids, or\n * required the following due to ≥1 exacerbations within 12 months before baseline\n\n * systemic (oral and/or parenteral) corticosteroid treatment, or\n * hospitalization for \\>24 hours.\n* Have known liver cirrhosis and/or chronic hepatitis of any etiology.\n* Had Dupilumab treatment within 4 weeks prior to baseline\n* Had prior treatment with tralokinumab.\n* Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline\n* Treatment with any of the following agents within 4 weeks prior to the baseline\n\n * systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)\n * small molecules (e.g. JAK inhibitors)\n * phototherapy and photochemotherapy for AD'}, 'identificationModule': {'nctId': 'NCT05369403', 'acronym': 'ADapt', 'briefTitle': 'A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Open-Label, Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab', 'orgStudyIdInfo': {'id': '18499'}, 'secondaryIdInfos': [{'id': 'J2T-MC-KGBO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab', 'description': 'Participants will receive Lebrikizumab by subcutaneous (SC) injection.', 'interventionNames': ['Drug: Lebrikizumab']}], 'interventions': [{'name': 'Lebrikizumab', 'type': 'DRUG', 'otherNames': ['LY3650150', 'DRM06'], 'description': 'Administered SC', 'armGroupLabels': ['Lebrikizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'River Region Dermatology and Laser', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Medical Dermatology Specialists', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'First OC Dermatology', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Axon Clinical Research', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92677', 'city': 'Laguna Niguel', 'state': 'California', 'country': 'United States', 'facility': 'Avance Clinical Trials Inc', 'geoPoint': {'lat': 33.52253, 'lon': -117.70755}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90056', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Wallace Medical Group, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Cura Clinical Research', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '06030-2840', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Health', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '33436', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Medical Research of Boynton Beach', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Total Vein and Skin LLC', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Direct Helpers Research Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Hollywood Dermatology', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Dermatology and Laser Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ziaderm Research, LLC.', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31217', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Skin Care Physicians of Georgia', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Advanced Medical Research', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '60118', 'city': 'West Dundee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Dundee Dermatology', 'geoPoint': {'lat': 42.09808, 'lon': -88.28286}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70605', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Dermatology and Advanced Aesthetics', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Dermatology and Skin Cancer Specialists, LLC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '01915', 'city': 'Beverly', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Allcutis Research, Inc.', 'geoPoint': {'lat': 42.55843, 'lon': -70.88005}}, {'zip': '48326', 'city': 'Auburn Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakland Hills Dermatology', 'geoPoint': {'lat': 42.68753, 'lon': -83.2341}}, {'zip': '49316', 'city': 'Caledonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'The Derm Institute of West Michigan', 'geoPoint': {'lat': 42.7892, 'lon': -85.51669}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Revival Research Institute - Troy', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'MediSearch Clinical Trials', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Allcutis Research, Inc', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '08520', 'city': 'East Windsor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Windsor Dermatology, P.C.', 'geoPoint': {'lat': 40.268, 'lon': -74.54043}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Sadick Research Group', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'OptiSkin Medical', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dermatologists of Greater Columbus', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}, {'zip': '19341', 'city': 'Exton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dermatology and Skin Surgery Center, PC', 'geoPoint': {'lat': 40.029, 'lon': -75.62077}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Clinical Partners, LLC', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Complete Dermatology', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Dermatology Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}