Status:
TERMINATED
BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Primary Sjögren's Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986325 in healthy participants and participants with primary Sjögren's syndrome. The results wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2023
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04684654
Start Date
February 16 2021
End Date
July 25 2023
Last Update
August 23 2023
Active Locations (2)
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1
Medvin Clinical Research - Metyas
Covina, California, United States, 91722
2
Local Institution - 0001
Berlin, Germany, 10117