Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-30 @ 1:32 PM
Study NCT ID:
NCT04162769
Status:
COMPLETED
Last Update Posted:
2022-11-04
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656249', 'term': 'etrasimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ct.gov@arenapharm.com', 'phone': '+1 855-218-9153', 'title': 'Arena CT.gov Administrator', 'organization': 'Arena Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, TEAEs and SAEs were collected for Double-blind Treatment period (12-Week) and for OLE Period (52-Week).', 'description': 'Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 19, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 31, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 22, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 53, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Excessive cerumen production', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Eyelid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tongue discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Infection parasitic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 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'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 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{'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-58.68', 'spread': '7.735', 'groupId': 'OG000'}, {'value': '-57.18', 'spread': '7.800', 'groupId': 'OG001'}, {'value': '-48.41', 'spread': '8.378', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.1198', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.28', 'ciLowerLimit': '-23.228', 'ciUpperLimit': '2.674', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.605', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.1783', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.77', 'ciLowerLimit': '-21.544', 'ciUpperLimit': '4.002', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.515', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI evaluates severity of participant\'s AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as Day 1 pre-randomization assessments.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Percentage of Participants Achieving EASI-75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000', 'lowerLimit': '15.62', 'upperLimit': '42.64'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '24.51', 'upperLimit': '53.62'}, {'value': '26.1', 'groupId': 'OG002', 'lowerLimit': '14.27', 'upperLimit': '41.13'}]}]}], 'analyses': [{'pValue': '=0.9826', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-18.52', 'ciUpperLimit': '18.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.34', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.1891', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '-6.12', 'ciUpperLimit': '32.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.78', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI-75 is defined as a 75% reduction or greater in EASI score from Baseline to Week 12. Baseline is defined as Day 1 pre-randomization assessments.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population.'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Percentage of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of >= 2 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '6.20', 'upperLimit': '28.31'}, {'value': '29.8', 'groupId': 'OG001', 'lowerLimit': '17.34', 'upperLimit': '44.89'}, {'value': '13.0', 'groupId': 'OG002', 'lowerLimit': '4.94', 'upperLimit': '26.26'}]}]}], 'analyses': [{'pValue': '=0.7694', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-12.29', 'ciUpperLimit': '16.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.38', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0450', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '0.79', 'ciUpperLimit': '34.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.47', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The vIGA scale for AD is a 5-point scale to measure disease severity. The vIGA score was selected using descriptors that best described the overall appearance of skin lesions at a given time point using the following scoring: 0 = clear (no inflammatory signs of AD); 1 = almost clear (barely perceptible erythema and papulation); 2 = mild (slight but definite erythema and papulation); 3 = moderate (clearly perceptible erythema and papulation); and 4 = severe (marked erythema and papulation); Higher score indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population.'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.401', 'spread': '8.236', 'groupId': 'OG000'}, {'value': '-35.044', 'spread': '7.910', 'groupId': 'OG001'}, {'value': '-24.374', 'spread': '8.492', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.0558', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.03', 'ciLowerLimit': '-28.406', 'ciUpperLimit': '0.352', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.295', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.1363', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.67', 'ciLowerLimit': '-24.737', 'ciUpperLimit': '3.397', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.134', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Pruritus NRS is an assessment tool that was used to report the intensity of a participant\'s pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Percentage of Participants With Improvement (Reduction) in Peak Pruritus NRS Greater Than or Equal to (>=)3 From an Itch Daily Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '29.26', 'upperLimit': '61.51'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '29.26', 'upperLimit': '61.51'}, {'value': '41.0', 'groupId': 'OG002', 'lowerLimit': '25.57', 'upperLimit': '57.90'}]}]}], 'analyses': [{'pValue': '=0.7143', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-18.00', 'ciUpperLimit': '26.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.33', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.6488', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '-16.62', 'ciUpperLimit': '26.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.09', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Pruritus NRS is an assessment tool that was used to report the intensity of a participant\'s pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Percentage of participants with improvement (reduction) in peak pruritus NRS \\>=3 from an itch daily diary is presented. Baseline is defined as Day 1 pre-randomization assessments.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Percentage of Participants Achieving EASI-50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000', 'lowerLimit': '46.38', 'upperLimit': '75.49'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '50.69', 'upperLimit': '79.14'}, {'value': '52.2', 'groupId': 'OG002', 'lowerLimit': '36.95', 'upperLimit': '67.11'}]}]}], 'analyses': [{'pValue': '=0.3981', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '-11.27', 'ciUpperLimit': '28.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.22', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.1410', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.2', 'ciLowerLimit': '-4.72', 'ciUpperLimit': '35.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.17', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI-50 is defined as a 50% reduction or greater of EASI from Baseline to Week 12. Percentage of participants achieving EASI-50 is presented. Baseline is defined as Day 1 pre-randomization assessments.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Percentage of Participants Achieving EASI-90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '9.15', 'upperLimit': '33.26'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '6.20', 'upperLimit': '28.31'}, {'value': '10.9', 'groupId': 'OG002', 'lowerLimit': '3.62', 'upperLimit': '23.57'}]}]}], 'analyses': [{'pValue': '=0.2690', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '-6.61', 'ciUpperLimit': '23.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.65', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.5428', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-9.56', 'ciUpperLimit': '18.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.09', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI-90 is defined as as a 90% reduction or greater of EASI from Baseline to Week 12. Percentage of participants achieving EASI-90 is presented Baseline is defined as Day 1 pre-randomization assessments.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-34.725', 'spread': '7.047', 'groupId': 'OG000'}, {'value': '-45.153', 'spread': '6.860', 'groupId': 'OG001'}, {'value': '-31.913', 'spread': '7.012', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '=0.7163', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.81', 'ciLowerLimit': '-18.089', 'ciUpperLimit': '12.466', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.721', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.0840', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.24', 'ciLowerLimit': '-28.284', 'ciUpperLimit': '1.805', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.602', 'groupDescription': 'Week 12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'BSA affected by AD were assessed for each section of the body. The possible highest score for each region was: head and neck (9%), anterior trunk (18%), back (18%), upper limbs (18%), lower limbs (36%), and genitals (1%) and were reported as a percentage of all major body sections combined; higher % BSA indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Open-label Extension (OLE) Period: Percent Change in EASI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) and continued to the OLE period received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.39', 'spread': '258.796', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'EASI evaluates severity of participant\'s AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population included all randomized participants who received at least 1 dose of study intervention. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Number of Participants Achieving a EASI-75 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'EASI evaluates severity of participant\'s AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. EASI-75 is defined as a \\>=75% reduction or greater of EASI from Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of ≥ 2 Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'The vIGA scale for AD is a 5-point scale to measure disease severity. The vIGA score was selected using descriptors that best described the overall appearance of skin lesions at a given time point using the following scoring: 0 = clear (no inflammatory signs of AD); 1 = almost clear (barely perceptible erythema and papulation); 2 = mild (slight but definite erythema and papulation); 3 = moderate (clearly perceptible erythema and papulation); and 4 = severe (marked erythema and papulation); Higher score indicated greater severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-64.27', 'spread': '69.273', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'The SCORAD is a validated measure of the extent and severity of AD using 3 components: A = extent or affected BSA, B = severity and C = subjective symptoms. The extent of AD was assessed as percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. The severity of 6 specific symptoms was assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points, assigned as "B" in the overall SCORAD calculation). Subjective assessment of itch and sleeplessness was recorded for each symptom by the participant or relative on a Visual Analogue Scale, where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum possible score of 20. This parameter is assigned as "C" in the overall SCORAD calculation. The total SCORAD ranged from 0 (no disease) to 103 (severe disease); higher score indicated more severe AD.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Percent Change in Percent BSA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-68.47', 'spread': '52.083', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'BSA affected by AD were assessed for each section of the body. The possible highest score for each region was: head and neck (9%), anterior trunk (18%), back (18%), upper limbs (18%), lower limbs (36%), and genitals (1%) and were reported as a percentage of all major body sections combined; higher % BSA indicated greater severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.87', 'spread': '45.219', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 16) and Week 28', 'description': 'Pruritus NRS is an assessment tool that was used to report the intensity of a participant\'s pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Change in Patient-Oriented Eczema Measure (POEM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '6.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': "The POEM is a participant-derived validated tool used for monitoring atopic eczema severity. The POEM consisted of 7 questions asking participants to rank how many days over the past 7 days they had experienced specific AD-related symptoms. Each of the 7 questions carried equal weight and was scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The scores from the 7 questions were added up to give an overall POEM score as: 0-2 = 'clear/almost clear', 3-7 = 'mild', 8-16 = 'moderate', 17-24 = 'severe', and 25-28 = 'very severe atopic eczema'; higher scores indicated worse atopic eczema severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Change in Dermatology Life Quality Index (DLQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'spread': '6.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'The DLQI is a validated 10-item questionnaire designed to measure the impact of skin disease on the Quality of Life (QoL). DLQI is a response to 10 items, which assessed QoL over the past week. For each item, the scale was rated as follows: 0 = "not at all"; 1 = "a little"; 2 = "a lot"; 3 = "very much," with an overall scoring system of 0 to 30; higher scores indicated a poor QoL. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'OLE Period: Change in Patient Global Assessment (PGA) of Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.23', 'spread': '1.209', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': "PGA is an assessment tool that was used by participant to rate the disease and disease severity. Participants rated their overall well-being based on a 5-point Likert scale from poor to excellent. Response choices were: 1- 'Poor', 2- 'Fair', 3- 'Good', 4- 'Very Good,' or 5- 'Excellent'; higher scores indicated better well-being. For the 5-point Likert scale, a positive change from baseline indicates an improvement. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set Population. Only those participants with data available at the specified time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'FG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'FG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'FG003', 'title': 'OLE Period: Etrasimod 2 mg', 'description': 'Participants who successfully completed 12 weeks of Double-blind treatment (who received etrasimod 1 mg, etrasimod 2 mg and placebo) continued to the OLE period and received etrasimod 2 mg orally once daily for 52 weeks. Participants who stopped taking study treatment before the end of the Double-blind Treatment period were not eligible to participate in the OLE Period.'}], 'periods': [{'title': 'Double-blind Treatment (12-Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'OLE Period (52-Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': '12 participants completed the Double-blind treatment period but did not enter the OLE Phase', 'groupId': 'FG003', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This was a 2-treatment period study (12-Week Double-Blind Treatment Period and 52-Week Open-label extension \\[OLE\\] Period), to evaluate the safety and efficacy of etrasimod monotherapy compared with placebo in participants with moderate-to-severe atopic dermatitis (AD), whose disease was not adequately controlled with topical therapies.', 'preAssignmentDetails': 'A total of 140 participants were randomized into the 12-week Double-Blind Treatment Period and a total of 95 participants continued into the 52-Week OLE Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind Treatment Period: Etrasimod 1 Milligrams (mg)', 'description': 'Participants with chronic AD were randomized to receive etrasimod 1 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'BG001', 'title': 'Double-blind Treatment Period: Etrasimod 2 mg', 'description': 'Participants with chronic AD were randomized to receive etrasimod 2 mg orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'BG002', 'title': 'Double-blind Treatment Period: Placebo', 'description': 'Participants with chronic AD were randomized to receive placebo orally once daily for 12 weeks. Participants who successfully completed 12 weeks of Double-blind treatment continued to have access to etrasimod in the OLE period of the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': '13.32', 'groupId': 'BG000'}, {'value': '41.8', 'spread': '14.83', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '16.16', 'groupId': 'BG002'}, {'value': '42.5', 'spread': '14.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants, irrespective of whether they received any study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-19', 'size': 6711224, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-24T11:02', 'hasProtocol': True}, {'date': '2021-11-05', 'size': 2366186, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-24T11:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2021-09-13', 'completionDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2019-11-12', 'dispFirstSubmitQcDate': '2022-10-10', 'resultsFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2019-11-12', 'dispFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-10', 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Double-blind Treatment Period: Percent Change in Eczema Area and Severity Index (EASI) Score', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI evaluates severity of participant\'s AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as Day 1 pre-randomization assessments.'}], 'secondaryOutcomes': [{'measure': 'Double-blind Treatment Period: Percentage of Participants Achieving EASI-75', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI-75 is defined as a 75% reduction or greater in EASI score from Baseline to Week 12. Baseline is defined as Day 1 pre-randomization assessments.'}, {'measure': 'Double-blind Treatment Period: Percentage of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of >= 2 Points', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'The vIGA scale for AD is a 5-point scale to measure disease severity. The vIGA score was selected using descriptors that best described the overall appearance of skin lesions at a given time point using the following scoring: 0 = clear (no inflammatory signs of AD); 1 = almost clear (barely perceptible erythema and papulation); 2 = mild (slight but definite erythema and papulation); 3 = moderate (clearly perceptible erythema and papulation); and 4 = severe (marked erythema and papulation); Higher score indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments.'}, {'measure': 'Double-blind Treatment Period: Percent Change in Weekly Peak Pruritus Numerical Rating Scale (NRS) From an Itch Daily Diary', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Pruritus NRS is an assessment tool that was used to report the intensity of a participant\'s pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments.'}, {'measure': 'Double-blind Treatment Period: Percentage of Participants With Improvement (Reduction) in Peak Pruritus NRS Greater Than or Equal to (>=)3 From an Itch Daily Diary', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'Pruritus NRS is an assessment tool that was used to report the intensity of a participant\'s pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Percentage of participants with improvement (reduction) in peak pruritus NRS \\>=3 from an itch daily diary is presented. Baseline is defined as Day 1 pre-randomization assessments.'}, {'measure': 'Double-blind Treatment Period: Percentage of Participants Achieving EASI-50', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI-50 is defined as a 50% reduction or greater of EASI from Baseline to Week 12. Percentage of participants achieving EASI-50 is presented. Baseline is defined as Day 1 pre-randomization assessments.'}, {'measure': 'Double-blind Treatment Period: Percentage of Participants Achieving EASI-90', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'EASI-90 is defined as as a 90% reduction or greater of EASI from Baseline to Week 12. Percentage of participants achieving EASI-90 is presented Baseline is defined as Day 1 pre-randomization assessments.'}, {'measure': 'Double-blind Treatment Period: Percent Change in Percent Body Surface Area (BSA)', 'timeFrame': 'Baseline (Day 1) and Week 12', 'description': 'BSA affected by AD were assessed for each section of the body. The possible highest score for each region was: head and neck (9%), anterior trunk (18%), back (18%), upper limbs (18%), lower limbs (36%), and genitals (1%) and were reported as a percentage of all major body sections combined; higher % BSA indicated greater severity. Baseline is defined as Day 1 pre-randomization assessments'}, {'measure': 'Open-label Extension (OLE) Period: Percent Change in EASI', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'EASI evaluates severity of participant\'s AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.'}, {'measure': 'OLE Period: Number of Participants Achieving a EASI-75 Score', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'EASI evaluates severity of participant\'s AD based on severity of AD clinical signs and percent (%) of body surface area (BSA) affected. EASI is a composite scoring assessment of the affected area in 4 specific disease characteristics (erythema, thickness \\[induration, papulation, edema\\], scratching \\[excoriation\\], and lichenification), which was each assessed on a scale of "0" (absent) through "3" (severe). The EASI Area Score is documented for 4 regions of the body. Region 1: head and neck; Region 2: trunk (including genital area); Region 3: upper limbs; and Region 4: lower limbs (including buttocks), with the area of AD involvement assessed as a percentage by body area and converted to a score of 0 to 6. Total EASI score ranged from 0 to 72; higher score indicated greater severity of AD. EASI-75 is defined as a \\>=75% reduction or greater of EASI from Baseline.'}, {'measure': 'OLE Period: Number of Participants Achieving a Validated Investigator Global Assessment (vIGA) 0 or 1 Score and a Reduction From Baseline of ≥ 2 Points', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'The vIGA scale for AD is a 5-point scale to measure disease severity. The vIGA score was selected using descriptors that best described the overall appearance of skin lesions at a given time point using the following scoring: 0 = clear (no inflammatory signs of AD); 1 = almost clear (barely perceptible erythema and papulation); 2 = mild (slight but definite erythema and papulation); 3 = moderate (clearly perceptible erythema and papulation); and 4 = severe (marked erythema and papulation); Higher score indicated greater severity.'}, {'measure': 'OLE Period: Percent Change in SCORing Atopic Dermatitis (SCORAD) Total Score', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'The SCORAD is a validated measure of the extent and severity of AD using 3 components: A = extent or affected BSA, B = severity and C = subjective symptoms. The extent of AD was assessed as percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. The severity of 6 specific symptoms was assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points, assigned as "B" in the overall SCORAD calculation). Subjective assessment of itch and sleeplessness was recorded for each symptom by the participant or relative on a Visual Analogue Scale, where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum possible score of 20. This parameter is assigned as "C" in the overall SCORAD calculation. The total SCORAD ranged from 0 (no disease) to 103 (severe disease); higher score indicated more severe AD.'}, {'measure': 'OLE Period: Percent Change in Percent BSA', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'BSA affected by AD were assessed for each section of the body. The possible highest score for each region was: head and neck (9%), anterior trunk (18%), back (18%), upper limbs (18%), lower limbs (36%), and genitals (1%) and were reported as a percentage of all major body sections combined; higher % BSA indicated greater severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.'}, {'measure': 'OLE Period: Percent Change in Weekly Peak Pruritus NRS From an Itch Daily Diary', 'timeFrame': 'Baseline (Week 16) and Week 28', 'description': 'Pruritus NRS is an assessment tool that was used to report the intensity of a participant\'s pruritus (itch). The scale for the pruritus NRS ranged from 0 to 10 with 0 being "no itch" and 10 being "the worst itch imaginable; higher scores indicated greater severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.'}, {'measure': 'OLE Period: Change in Patient-Oriented Eczema Measure (POEM)', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': "The POEM is a participant-derived validated tool used for monitoring atopic eczema severity. The POEM consisted of 7 questions asking participants to rank how many days over the past 7 days they had experienced specific AD-related symptoms. Each of the 7 questions carried equal weight and was scored from 0 to 4 as follows: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; Every day = 4. The scores from the 7 questions were added up to give an overall POEM score as: 0-2 = 'clear/almost clear', 3-7 = 'mild', 8-16 = 'moderate', 17-24 = 'severe', and 25-28 = 'very severe atopic eczema'; higher scores indicated worse atopic eczema severity. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16."}, {'measure': 'OLE Period: Change in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': 'The DLQI is a validated 10-item questionnaire designed to measure the impact of skin disease on the Quality of Life (QoL). DLQI is a response to 10 items, which assessed QoL over the past week. For each item, the scale was rated as follows: 0 = "not at all"; 1 = "a little"; 2 = "a lot"; 3 = "very much," with an overall scoring system of 0 to 30; higher scores indicated a poor QoL. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16.'}, {'measure': 'OLE Period: Change in Patient Global Assessment (PGA) of Disease', 'timeFrame': 'Baseline (Week 16) and Week 68', 'description': "PGA is an assessment tool that was used by participant to rate the disease and disease severity. Participants rated their overall well-being based on a 5-point Likert scale from poor to excellent. Response choices were: 1- 'Poor', 2- 'Fair', 3- 'Good', 4- 'Very Good,' or 5- 'Excellent'; higher scores indicated better well-being. For the 5-point Likert scale, a positive change from baseline indicates an improvement. Baseline is defined as the last measurement prior to the first etrasimod dose started at Week 16."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate-to-severe atopic dermatitis', 'Etrasimod', 'APD334'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '39575597', 'type': 'DERIVED', 'citation': 'Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria, that has been present for at least 1 year prior to the Screening Visit\n* Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit and ≥ 16 at the Baseline Visit\n* Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the 0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening and Baseline visits\n\nExclusion Criteria:\n\n* Presence of skin comorbidities that would interfere with study assessments of the underlying disease."}, 'identificationModule': {'nctId': 'NCT04162769', 'acronym': 'ADVISE', 'briefTitle': 'A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arena Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blinded, Placebo-Controlled 16-Week Study (With a 52-Week Open-Label Extension) to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'APD334-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)', 'interventionNames': ['Drug: Etrasimod 1 mg']}, {'type': 'EXPERIMENTAL', 'label': '12-Week Double-Blind Treatment Period: Etrasimod 2 mg', 'interventionNames': ['Drug: Etrasimod 2 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '12-Week Double-Blind Treatment Period: Placebo', 'interventionNames': ['Drug: Etrasimod matching placebo']}, {'type': 'EXPERIMENTAL', 'label': '52-Week Open-Label Extension Period: Etrasimod 2 mg', 'interventionNames': ['Drug: Etrasimod 2 mg']}], 'interventions': [{'name': 'Etrasimod 1 mg', 'type': 'DRUG', 'otherNames': ['APD334'], 'description': 'Etrasimod 1 mg tablet taken by mouth, once daily', 'armGroupLabels': ['12-Week Double-Blind Treatment Period: Etrasimod 1 milligrams (mg)']}, {'name': 'Etrasimod 2 mg', 'type': 'DRUG', 'otherNames': ['APD334'], 'description': 'Etrasimod 2 mg tablet taken by mouth, once daily.', 'armGroupLabels': ['12-Week Double-Blind Treatment Period: Etrasimod 2 mg', '52-Week Open-Label Extension Period: Etrasimod 2 mg']}, {'name': 'Etrasimod matching placebo', 'type': 'DRUG', 'description': 'Etrasimod matching placebo tablet by mouth, once daily.', 'armGroupLabels': ['12-Week Double-Blind Treatment Period: Placebo']}]}, 'contactsLocationsModule': {'locations': 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