Status:
COMPLETED
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2021
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT03252587
Start Date
September 21 2017
End Date
October 28 2021
Last Update
December 20 2022
Active Locations (192)
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1
Local Institution - 0178
Birmingham, Alabama, United States, 35205
2
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States, 72205
3
Local Institution - 0023
El Cajon, California, United States, 92020
4
BioSolutions Clinical Research Center
La Mesa, California, United States, 91942