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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT03252587

Run by

Bristol-Myers Squibb

People needed

363

Starts

2017-09-21

Expected to finish

2021-10-28

Last updated by the study team

2022-12-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
• Local Institution - 0023 — El Cajon, California, United States
• BioSolutions Clinical Research Center — La Mesa, California, United States
• Los Angeles County Hospital and University of Southern California Medical Center — Los Angeles, California, United States
• University of California at Irvine College of Medicine — Orange, California, United States
• Local Institution - 0227 — Palm Desert, California, United States
• Millennium Clinical Trials - Thousand Oaks — Thousand Oaks, California, United States
• The Lundquist Institute at Harbor-UCLA Medical Center — Torrance, California, United States
• Inland Rheumatology Clinical Trials — Upland, California, United States
• Local Institution - 0034 — Farmington, Connecticut, United States
• Local Institution - 0195 — New Haven, Connecticut, United States
• Local Institution - 0010 — Aventura, Florida, United States
• Local Institution - 0066 — Brandon, Florida, United States
• Local Institution - 0214 — Gainesville, Florida, United States
• Local Institution - 0233 — Orlando, Florida, United States
• Local Institution - 0057 — Ormond Beach, Florida, United States
• Local Institution - 0002 — Tamarac, Florida, United States
• Local Institution - 0038 — Tampa, Florida, United States
• BayCare Medical Group — Tampa, Florida, United States
• Local Institution - 0206 — Atlanta, Georgia, United States
• Local Institution - 0022 — Decatur, Georgia, United States
• Local Institution - 0083 — Lawrenceville, Georgia, United States
• Arthritis Research and Treatment Center — Stockbridge, Georgia, United States
• Klein & Associates — Cumberland, Maryland, United States
• Local Institution - 0178 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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