Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-18 @ 11:40 PM
Study NCT ID:
NCT03611751
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2018-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'C505730', 'term': 'apremilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks)', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'BMS-986165 (Week 0 up to Week 16)', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 511, 'otherNumAffected': 114, 'seriousNumAtRisk': 510, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo (Week 0 up to Week 16)', 'description': 'Participants receive Placebo by oral administration once daily (QD)', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 255, 'otherNumAffected': 61, 'seriousNumAtRisk': 254, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Apremilast (Week 0 up to Week 16)', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n10 mg used for titration Day 1 through Day 3 morning dose\n\n20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n\n30 mg from Day 5 evening dose onwards', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 86, 'seriousNumAtRisk': 254, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'BMS-986165 (Week 0 up to Week 52)', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)', 'otherNumAtRisk': 833, 'deathsNumAtRisk': 834, 'otherNumAffected': 249, 'seriousNumAtRisk': 833, 'deathsNumAffected': 2, 'seriousNumAffected': 24}, {'id': 'EG004', 'title': 'Placebo (Week 0 up to Week 52)', 'description': 'Participants receive Placebo by oral administration once daily (QD)', 'otherNumAtRisk': 501, 'deathsNumAtRisk': 502, 'otherNumAffected': 97, 'seriousNumAtRisk': 501, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Apremilast (Week 0 up to Week 52)', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n10 mg used for titration Day 1 through Day 3 morning dose\n\n20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n\n30 mg from Day 5 evening dose onwards', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 98, 'seriousNumAtRisk': 254, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 133}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 47}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 74}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastrointestinal arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pancreatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mycoplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Purulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vascular graft infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Excessive granulation tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 833, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 501, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 254, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.55', 'ciLowerLimit': '6.54', 'ciUpperLimit': '17.00', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the BMS-986165 and Placebo arms'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.49', 'ciLowerLimit': '6.65', 'ciUpperLimit': '16.55', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the BMS-986165 and Placebo arms'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.42', 'ciLowerLimit': '5.45', 'ciUpperLimit': '23.93', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.74', 'ciLowerLimit': '1.18', 'ciUpperLimit': '2.56', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.21', 'ciLowerLimit': '2.89', 'ciUpperLimit': '29.40', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0051', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.55', 'ciLowerLimit': '1.30', 'ciUpperLimit': '5.00', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.44', 'ciLowerLimit': '4.62', 'ciUpperLimit': '45.11', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.85', 'ciLowerLimit': '1.61', 'ciUpperLimit': '5.03', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.9', 'spread': '25.22', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '19.58', 'groupId': 'OG001'}, {'value': '-21.5', 'spread': '25.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.6', 'ciLowerLimit': '-26.9', 'ciUpperLimit': '-20.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.67', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '-3.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nA modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with evaluable baseline and week 16 PSSD scores.'}, {'type': 'SECONDARY', 'title': 'Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.40', 'ciLowerLimit': '1.94', 'ciUpperLimit': '21.15', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0928', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '0.89', 'ciUpperLimit': '3.71', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score \\>= 1 using the non-responder imputation (NRI) method.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline PSSD symptom score ≥ 1'}, {'type': 'SECONDARY', 'title': "The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.85', 'ciLowerLimit': '4.34', 'ciUpperLimit': '10.81', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '1.77', 'ciUpperLimit': '3.91', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 .\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline ss-PGA score \\>=3'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.38', 'ciLowerLimit': '3.42', 'ciUpperLimit': '8.47', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline DLQI score \\>=2. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0621', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.21', 'ciLowerLimit': '0.88', 'ciUpperLimit': '11.79', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score \\>=3.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline PGA-F score \\>=3. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.'}, {'type': 'SECONDARY', 'title': "The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6692', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.06', 'ciUpperLimit': '7.46', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3793', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.02', 'ciUpperLimit': '5.56', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline pp-PGA score \\>=3.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '271', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '1.29', 'ciUpperLimit': '2.41', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the BMS-986165 and Apremilast arms.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.01', 'ciLowerLimit': '1.45', 'ciUpperLimit': '2.78', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the BMS-986165 and Apremilast arms.'}, {'type': 'SECONDARY', 'title': 'Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'OG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '197.0', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': '125.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Week 24 to Week 52 (up to approximately 28 weeks)', 'description': 'Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline.\n\nThe PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had PASI 75 response at week 24. Pre-specified to report participants from their original randomization.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.47', 'ciLowerLimit': '1.78', 'ciUpperLimit': '3.43', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '1.78', 'ciUpperLimit': '3.36', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 24', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nPASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '504', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'OG001', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '1.43', 'ciUpperLimit': '3.01', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and week 24', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nPASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'FG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}], 'periods': [{'title': 'Pre-treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '511'}, {'groupId': 'FG001', 'numSubjects': '255'}, {'groupId': 'FG002', 'numSubjects': '254'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '254'}, {'groupId': 'FG002', 'numSubjects': '254'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Week 0 - Week 16', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '254'}, {'groupId': 'FG002', 'numSubjects': '254'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '456'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '217'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Treatment Week 16 - Week 24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '667'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '217'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '642'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Treatment Week 24 - Week 52', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '604'}, {'groupId': 'FG001', 'numSubjects': '247'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '535'}, {'groupId': 'FG001', 'numSubjects': '214'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1 Participant stopped treatment after week 16 and re-entered in treatment period Week 24-52.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}, {'value': '1020', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BMS-986165', 'description': 'Participants receive 6 mg of BMS-986165 by oral administration once daily (QD).\n\nParticipants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receive Placebo by oral administration once daily (QD).\n\nParticipants originally randomized to placebo switch to BMS-986165 at Week 16.'}, {'id': 'BG002', 'title': 'Apremilast', 'description': 'Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label)\n\n* 10 mg used for titration Day 1 through Day 3 morning dose\n* 20 mg used for titration Day 3 evening dose through Day 5 morning dose.\n* 30 mg from Day 5 evening dose onwards.\n\nParticipants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '13.37', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '13.57', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '13.28', 'groupId': 'BG002'}, {'value': '46.9', 'spread': '13.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '346', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '336', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '674', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '445', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}, {'value': '894', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '474', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}, {'value': '935', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-21', 'size': 3599730, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-06T11:10', 'hasProtocol': True}, {'date': '2020-05-21', 'size': 1069076, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-06T11:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1020}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2021-11-29', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-26', 'studyFirstSubmitDate': '2018-07-25', 'dispFirstSubmitQcDate': '2022-11-26', 'resultsFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2018-08-01', 'dispFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-26', 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)", 'timeFrame': 'Week 16', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': 'The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': 'The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': 'The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)', 'timeFrame': 'Week 16', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': 'Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nA modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.'}, {'measure': 'Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16', 'timeFrame': 'Week 16', 'description': 'Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score \\>= 1 using the non-responder imputation (NRI) method.'}, {'measure': "The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)", 'timeFrame': 'Week 16', 'description': "The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 .\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason."}, {'measure': 'The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)', 'timeFrame': 'Week 16', 'description': 'The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': 'The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)', 'timeFrame': 'Week 16', 'description': 'The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score \\>=3.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': "The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)", 'timeFrame': 'Week 16', 'description': "The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3."}, {'measure': 'The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)', 'timeFrame': 'Baseline and Week 16', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nThe PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': 'The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)', 'timeFrame': 'Week 16', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.'}, {'measure': 'Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders', 'timeFrame': 'From Week 24 to Week 52 (up to approximately 28 weeks)', 'description': 'Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline.\n\nThe PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.'}, {'measure': 'The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)', 'timeFrame': 'Week 24', 'description': 'The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1.\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.'}, {'measure': 'The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)', 'timeFrame': 'Baseline and Week 24', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nPASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.'}, {'measure': 'The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)', 'timeFrame': 'Baseline and week 24', 'description': 'The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.\n\nPASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).\n\nNon-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '41350512', 'type': 'DERIVED', 'citation': 'Armstrong AW, Warren RB, Sofen H, Spelman L, Linaberry M, Becker B, Jou YM, Daamen C, Kimball AB. Deucravacitinib in Plaque Psoriasis After Inadequate Response to Apremilast: Phase 3 POETYK Analysis. Dermatol Ther (Heidelb). 2025 Dec 5. doi: 10.1007/s13555-025-01606-9. Online ahead of print.'}, {'pmid': '40445270', 'type': 'DERIVED', 'citation': 'Merola JF, Mease PJ, Armstrong AW, Strand V, Lehman T, Varga S, Choi JC, Becker B, Zhong Y, Colombo MJ, Thaci D, Bili A, Gottlieb AB. Deucravacitinib in Patients with Plaque Psoriasis Who Screened Positive for Psoriatic Arthritis: Improvements in Joint Pain and the Impact of Musculoskeletal Symptoms. Dermatol Ther (Heidelb). 2025 Aug;15(8):2281-2293. doi: 10.1007/s13555-025-01428-9. Epub 2025 May 30.'}, {'pmid': '40113724', 'type': 'DERIVED', 'citation': 'Armstrong AW, Kircik L, Stein Gold L, Strober B, De Oliveira CHMC, Vaile J, Jou YM, Daamen C, Scharnitz T, Lebwohl M. Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials. Dermatol Ther (Heidelb). 2025 Apr;15(4):1025-1035. doi: 10.1007/s13555-025-01362-w. Epub 2025 Mar 20.'}, {'pmid': '39602111', 'type': 'DERIVED', 'citation': 'Armstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaci D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.'}, {'pmid': '39080153', 'type': 'DERIVED', 'citation': 'Armstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA. Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials. Dermatol Ther (Heidelb). 2024 Aug;14(8):2235-2248. doi: 10.1007/s13555-024-01224-x. Epub 2024 Jul 30.'}, {'pmid': '37150956', 'type': 'DERIVED', 'citation': 'Strober B, Thaci D, Sofen H, Kircik L, Gordon KB, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp KA. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary. Immunotherapy. 2023 Aug;15(11):787-797. doi: 10.2217/imt-2023-0062. Epub 2023 May 7.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Plaque psoriasis for at least 6 months\n* Moderate to severe disease\n* Candidate for phototherapy or systemic therapy\n\nExclusion Criteria:\n\n* Other forms of psoriasis\n* History of recent infection\n* Prior exposure to BMS-986165 or active comparator\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03611751', 'acronym': 'POETYK-PSO-2', 'briefTitle': 'An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'IM011-047'}, 'secondaryIdInfos': [{'id': '2018-001925-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986165', 'description': 'BMS-986165 oral administration', 'interventionNames': ['Drug: BMS-986165']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral administration', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator', 'description': 'Active comparator oral administration', 'interventionNames': ['Drug: Apremilast']}], 'interventions': [{'name': 'BMS-986165', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986165']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo']}, {'name': 'Apremilast', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Active comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Dermatology Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Kirklin Clinic of UAB Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alliance Dermatology and Mohs Center - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Consortium - Tempe', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Johnson Dermatology', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Burke Pharmaceutical Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72212', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Applied Research Center of Arkansas', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology Clinical Research', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Associates in Research, Inc.', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Marvel Clinical Research', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Interspond - Long Beach Clinical Trials', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90045-3606', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LA Universal Research Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Health Systems', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93405', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'San Luis Dermatology and Laser Clinic', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '92078', 'city': 'San Marcos', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research - San Marcos', 'geoPoint': {'lat': 33.14337, 'lon': -117.16614}}, {'zip': '94582', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Research', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Synexus - Santa Rosa', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Care Access Research - Walnut Creek', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Therapeutics Consortium', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Care Research', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'ERN - Accel Research - Avail', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Interspond - Savin Medical Group', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Synexus Clinical Research - Saint Petersburg', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Progressive Medical Research', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Clinical Research - Corporate Office', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '33351', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'Precision Clinical Research - Corporate Office', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moore Clinical Research - South Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida/USF Health', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'ForCare Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Marietta Dermatology & The Skin Cancer Center', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Advanced Clinical Research - Idaho', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '60089', 'city': 'Buffalo Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Glazer Dermatology', 'geoPoint': {'lat': 42.15141, 'lon': -87.95979}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '60118', 'city': 'West Dundee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Dundee Dermatology', 'geoPoint': {'lat': 42.09808, 'lon': -88.28286}}, {'zip': '46307', 'city': 'Crown Point', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dermatology Center of Northwest Indiana', 'geoPoint': {'lat': 41.41698, 'lon': -87.36531}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Synexus - 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