BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome
NCT ID: NCT04684654
Last Updated: 2023-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
118 participants
INTERVENTIONAL
2021-02-16
2023-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Part A (SAD)
Single Ascending Dose (SAD)
BMS-986325
Specified dose on specified days
Part A (SAD) Placebo
Placebo for BMS-986325
Specified dose on specified days
Part B (MAD)
Multiple Ascending Dose (MAD)
BMS-986325
Specified dose on specified days
Part B (MAD) Placebo
Placebo for BMS-986325
Specified dose on specified days
Part C (pSS)
Primary Sjögren's Syndrome (pSS)
BMS-986325
Specified dose on specified days
Part C (pSS) Placebo
Placebo for BMS-986325
Specified dose on specified days
Interventions
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BMS-986325
Specified dose on specified days
Placebo for BMS-986325
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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) 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
18 Years
75 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Medvin Clinical Research - Metyas
Covina, California, United States
Local Institution - 0001
Berlin, , Germany
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-003660-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1241-6583
Identifier Type: OTHER
Identifier Source: secondary_id
IM039-004
Identifier Type: -
Identifier Source: org_study_id
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