An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Purpose
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).
Condition
- Systemic Lupus Erythematosus
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit - Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE - One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory - Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)] - Men and women must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
- Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis - SLE overlap syndromes such as scleroderma and mixed connective tissue disease - Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG) - History of any significant drug allergy Other protocol defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BMS-986165 Dose 1 oral administration |
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|
|
Experimental BMS-986165 Dose 2 oral administration |
|
|
|
Experimental BMS-986165 Dose 3 oral administration |
|
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Placebo Comparator Placebo oral administration |
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More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb