Recruiting
BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome - IM039-004
Updated:
14 March, 2023
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ClinicalTrials.gov
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Inclusion Criteria: Healthy Participants (Part A and Part B) - Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations - Males and Females, ages 18, or local age of majority, to 50 years, inclusive at screening - Body mass index (BMI):18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening - Must be fully vaccinated against SARS-CoV-2 Participants with Sjögren's Syndrome (Part C) - Sjögren's syndrome in the absence of another immune-mediated disease or rheumatologic condition based on the 2016 American College of Rheumatology-European League Against Rheumatism (EULAR) Classification Criteria for primary Sjögren's syndrome (pSS) - Seropositive for anti-Sjögren's syndrome antigen A antibody - Males and females, ages 18, or local age of majority, to 75 years, inclusive at screening - Body mass index (BMI): 18.0 to 35.0 kg/m2; weight ≥ 50 kg at screening - Must be fully vaccinated against SARS-CoV-2 according to local regulations Exclusion Criteria: Healthy Participants (Part A and Part B) - Any significant acute or chronic medical illness - Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study Participants with Sjögren's Syndrome (Part C) - Systemic immune-mediated disease other than pSS, such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), mixed connective tissue disease, or systemic sclerosis, that can better explain the majority of the symptoms (ie, secondary Sjögren's syndrome) - Recent (within 6 months before Day 1) drug or alcohol abuse as defined by the 'Diagnostic Criteria for Drug and Alcohol Abuse' in the Diagnostic and Statistical Manual 5 (DSM 5) or corresponding local regulations Other protocol-defined inclusion/exclusion criteria apply
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