Recruiting
BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome - IM039-004
Updated:
30 June, 2023
|
ClinicalTrials.gov
Print Friendly Summary
Trial Details
Phase
Gender(s)
Age Range
Location(s)
Recruiting
Treatment Options
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
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information