Lead Sponsor

Bristol-Myers Squibb

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•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

•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