An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

• Status: Active, not recruiting
• Trial end date: 2021-11-13
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BMS-986165

Criteria

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