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Recruiting

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

Updated: 6 April, 2021   |   ClinicalTrials.gov

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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-65

    Age Range

  • 1

    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 A SAD Dose 10
Experimental: Part A SAD Dose 11 (Optional Arm)
Experimental: Part A SAD Dose 7
Experimental: Part A SAD Dose 8
Experimental: Part A SAD Dose 9
Placebo Comparator: Part A SAD Placebo 1
Placebo Comparator: Part A SAD Placebo 2
Experimental: Part B (MAD)
Biological: BMS-986325
Placebo Comparator: Part B (MAD) Placebo
Other: Placebo for BMS-986325
Experimental: Part B MAD Dose 1
Experimental: Part B MAD Dose 2
Experimental: Part B MAD Dose 3
Placebo Comparator: Part B MAD Placebo
Experimental: Part C (pSS)
Biological: BMS-986325
Placebo Comparator: Part C (pSS) Placebo
Other: Placebo for BMS-986325
Experimental: Part C pSS Dose 1
Experimental: Part C pSS Dose 2
Experimental: Part C pSS Dose 3 (Optional Arm)
Placebo Comparator: Part C pSS Placebo

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - BMI: 18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening - Must agree to follow specific methods of contraception, if applicable 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 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 65 years, inclusive at screening Exclusion Criteria: - Woman who are pregnant or breastfeeding - Inability to tolerate venipuncture and/or inadequate venous access Healthy Participants (Part A and Part B) - Any significant acute or chronic medical illness - Any other significant medical, psychiatric, and/or social reason as determined by the investigator 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 (i.e., secondary Sjögren's syndrome) - Another immune-mediated disease or inflammatory condition that could interfere with assessment of response of pSS to therapy (e.g., immunoglobulin G4 (IgG4)-related disease, systemic sclerosis, inflammatory bowel disease, gout) - Any other medical condition associated with sicca syndrome (e.g., history of head and neck radiation treatment, diabetes mellitus, sarcoidosis, chronic graft-versus host disease), participants with sicca symptoms secondary to ongoing medication use based on the investigator's assessment 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

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com