Active, Not Recruiting
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus - IM011-021
Updated: 19 July, 2021 | ClinicalTrials.gov
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Trial Details
Phase
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Active, Not Recruiting
Treatment Options
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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
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