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Recruiting

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

Updated: 16 August, 2019   |   ClinicalTrials.gov

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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.
Print this page IM011-021
Download Study Participant’s Guide

SELECT LANGUAGE

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • 135

    Location(s)

  • 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: - Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE and diagnosed ≥ 24 weeks before the screening visit - One of the following: antinuclear antibody (ANA) ≥ 1:80 or positive anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm) - Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points Exclusion Criteria: - Subjects with 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 ECG - History of any significant drug allergy Other protocol defined inclusion/exclusion criteria could apply

Have questions? Live support is available 24/7 - Call 855-907-3286 or Email Us

Have questions? Live support is available 24/7 -
Call 855-907-3286 or Email Us