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Active, Not Recruiting

An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus - IM011-021

Updated: 19 July, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: BMS-986165 Dose 1 oral administration
Drug: BMS-986165
Experimental: BMS-986165 Dose 2 oral administration
Drug: BMS-986165
Experimental: BMS-986165 Dose 3 oral administration
Drug: BMS-986165
Placebo Comparator: Placebo oral administration
Other: Placebo

Key Eligibility 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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