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Recruiting

BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome - IM039-004

Updated: 30 June, 2023   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • 2

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part A (SAD)
Biological: BMS-986325
Placebo Comparator: Part A (SAD) Placebo
Other: Placebo for BMS-986325
Experimental: Part B (MAD)
Biological: BMS-986325
Placebo Comparator: Part B (MAD) Placebo
Other: Placebo for BMS-986325
Experimental: Part C (pSS)
Biological: BMS-986325
Placebo Comparator: Part C (pSS) Placebo
Other: Placebo for BMS-986325

Key Eligibility Criteria

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). Historical diagnosis as pSS documented in medical records, using the 2016 ACR/EULAR criteria, is also acceptable - Seropositive for anti-Sjögren's syndrome antigen A antibody (anti-SSA). Previous anti-SSA are also acceptable, and results should be documented in the Case Report Form (CRF) as past medical history - 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 Healthy Participants (Part A and Part B) and Participants with Primary Sjögren's Syndrome (pSS) (Part C) - Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study Other protocol-defined inclusion/exclusion criteria apply

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Side Effects (Adverse Events) and other reportable events are defined here
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