Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-04 @ 8:43 AM
Study NCT ID:
NCT02843659
Status:
TERMINATED
Last Update Posted:
2018-10-04
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
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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': 'Up to 18 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects received subcutaneous (SC) injection of placebo matched to 12.5 milligram (mg) lulizumab (BMS-931699) weekly (QW) and oral tablets of placebo matched to 350 mg BMS-986142 once daily (QD) for 12 weeks.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lulizumab (BMS-931699) 12.5mg QW', 'description': 'Subjects received SC injection of 12.5 mg lulizumab (BMS-931699) QW and 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infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anticoagulation drug level above therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in ESSDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'timeFrame': 'At baseline and week 12', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}], 'timeFrame': 'At baseline, week 4 and week 8', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains.", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'timeFrame': 'At week 12', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'timeFrame': 'At week 12', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'timeFrame': 'At week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change in Baseline in ESSPRI Individual Component of Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change in Baseline in ESSPRI Individual Component of Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change in Baseline in ESSPRI Individual Component of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Unstimulated Salivary Flow Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Stimulated Salivary Flow Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Ocular Surface Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively. After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in Schrimer's Test", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'The test (without anaesthesia) was performed by placing a narrow calibrated filter-paper strip in the inferior cul-de-sac of each eye. Aqueous tear production was measured by the length in millimeters that the strip wets during the 5 minute test period', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Tear Break-up Time Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}], 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film. After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter. The TBUT, defined as the time in seconds between the subjects's last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded.", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 2'}, {'title': 'Week 4'}, {'title': 'Week 6'}, {'title': 'Week 8'}, {'title': 'Week 10'}, {'title': 'Week 12'}, {'title': 'Week 18'}], 'timeFrame': 'At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18', 'description': 'The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4-6 = Moderate Pain (interferes significantly with ADLs), 7-10 = Severe Pain (disabling; unable to perform ADLs)', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 2'}, {'title': 'Week 4'}, {'title': 'Week 6'}, {'title': 'Week 8'}, {'title': 'Week 10'}, {'title': 'Week 12'}, {'title': 'Week 18'}], 'timeFrame': 'At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18', 'description': 'The subjects overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 2'}, {'title': 'Week 4'}, {'title': 'Week 6'}, {'title': 'Week 8'}, {'title': 'Week 10'}, {'title': 'Week 12'}, {'title': 'Week 18'}], 'timeFrame': 'At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18', 'description': "The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease.", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Short Form-36 (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}, {'title': 'Week 18'}], 'timeFrame': 'At baseline, week 4, week 8, week 12, and week 18', 'description': 'First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank(missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Female Sexual Function Index (FSFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}, {'title': 'Week 18'}], 'timeFrame': 'At baseline, week 4, week 8, week 12, and week 18', 'description': 'The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'OG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'classes': [{'title': 'Week 4'}, {'title': 'Week 8'}, {'title': 'Week 12'}, {'title': 'Week 18'}], 'timeFrame': 'At baseline, week 4, week 8, week 12, and week 18', 'description': 'Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated and data is not reported for privacy reasons'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'FG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Administrative Reason by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "45 subjects enrolled, 18 subjects were randomized/treated. 15 subjects didn't complete the treatment period. The study was terminated and the remaining 15 randomized subjects who had not yet completed the double-blind period entered the follow-up period. Of the 15 subjects who entered the follow-up period, 12 did not complete the follow-up period"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BMS-931699/Lulizumab Injection', 'description': '(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)'}, {'id': 'BG001', 'title': 'BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)', 'description': 'For oral administration, 350 mg'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'For BMS-986142 50 mg tablet (round) or 150 mg tablet'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '11.34', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '8.77', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '13.30', 'groupId': 'BG002'}, {'value': '51.2', 'spread': '11.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-13', 'size': 4477861, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-24T12:25', 'hasProtocol': True}, {'date': '2017-05-15', 'size': 3138067, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-03T10:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'Inability to meet protocol objectives', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-03', 'studyFirstSubmitDate': '2016-07-08', 'resultsFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2016-07-21', 'lastUpdatePostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-03', 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in ESSDAI', 'timeFrame': 'At baseline and week 12', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening"}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8', 'timeFrame': 'At baseline, week 4 and week 8', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening"}, {'measure': 'Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains."}, {'measure': 'Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12', 'timeFrame': 'At week 12', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening"}, {'measure': 'Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12', 'timeFrame': 'At week 12', 'description': "The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening"}, {'measure': 'Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI', 'timeFrame': 'At week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains"}, {'measure': 'Mean Change in Baseline in ESSPRI Individual Component of Dryness', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains"}, {'measure': 'Mean Change in Baseline in ESSPRI Individual Component of Fatigue', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains"}, {'measure': 'Mean Change in Baseline in ESSPRI Individual Component of Pain', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains"}, {'measure': 'Mean Change From Baseline in Unstimulated Salivary Flow Rate', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.'}, {'measure': 'Mean Change From Baseline in Stimulated Salivary Flow Rate', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.'}, {'measure': 'Mean Change From Baseline in Ocular Surface Staining', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively. After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope).'}, {'measure': "Mean Change From Baseline in Schrimer's Test", 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': 'The test (without anaesthesia) was performed by placing a narrow calibrated filter-paper strip in the inferior cul-de-sac of each eye. Aqueous tear production was measured by the length in millimeters that the strip wets during the 5 minute test period'}, {'measure': 'Mean Change From Baseline in the Tear Break-up Time Test', 'timeFrame': 'At baseline, week 4, week 8, and week 12', 'description': "Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film. After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter. The TBUT, defined as the time in seconds between the subjects's last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded."}, {'measure': 'Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness', 'timeFrame': 'At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18', 'description': 'The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4-6 = Moderate Pain (interferes significantly with ADLs), 7-10 = Severe Pain (disabling; unable to perform ADLs)'}, {'measure': 'Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)', 'timeFrame': 'At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18', 'description': 'The subjects overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease'}, {'measure': 'Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)', 'timeFrame': 'At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18', 'description': "The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease."}, {'measure': 'Mean Change From Baseline in Short Form-36 (SF-36)', 'timeFrame': 'At baseline, week 4, week 8, week 12, and week 18', 'description': 'First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank(missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered'}, {'measure': 'Mean Change From Baseline in Female Sexual Function Index (FSFI)', 'timeFrame': 'At baseline, week 4, week 8, week 12, and week 18', 'description': 'The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women'}, {'measure': 'Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)', 'timeFrame': 'At baseline, week 4, week 8, week 12, and week 18', 'description': 'Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Sjögren's Syndrome"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', '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* Subjects diagnosed or classified as having moderate to severe primary Sjögren's Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at least 16 weeks prior to screening\n* ESSDAI ≥ 5 including disease activity (any score \\> 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy\n* Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody\n* Unstimulated whole saliva secretion \\> 0.01 ml/min\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted\n\nExclusion Criteria:\n\n* Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis)\n* Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit\n* Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection\n* Any significant concurrent medical condition at the time of screening or baseline visit\n* Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit\n* Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit\n* Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit\n* Oral corticosteroids \\> 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit\n\nOther protocol defined inclusion/exclusion criteria could apply"}, 'identificationModule': {'nctId': 'NCT02843659', 'briefTitle': "Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': "A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'IM128-035'}, 'secondaryIdInfos': [{'id': '2016-000101-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-931699', 'description': 'Subcutaneous weekly injection + daily oral placebo tablets', 'interventionNames': ['Drug: BMS-931699', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986142', 'description': 'Daily oral tablets + subcutaneous placebo (weekly) injection', 'interventionNames': ['Drug: BMS-986142', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Weekly subcutaneous placebo injection +daily oral placebo tablets', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BMS-931699', 'type': 'DRUG', 'otherNames': ['lulizumab'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-931699']}, {'name': 'BMS-986142', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986142']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-931699', 'BMS-986142', 'Placebo']}]}, 'contactsLocationsModule': 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