A Study Evaluating the Efficacy and Safety of BMS-986256 Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

• Status: Not yet recruiting
• Trial end date: 2024-05-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of BMS-986256 in participants with active SLE.

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

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

• Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria ≥ 12 weeks before the screening visit

• Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody>/= 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.

• Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash

Exclusion Criteria:

• Active severe lupus nephritis (LN) as assessed by the investigator

• Neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI

• Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE

• Antiphospholipid Syndrome

Other protocol-defined inclusion/exclusion criteria apply