Recruiting
An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus - IM011-021
Updated: 14 September, 2020 | ClinicalTrials.gov
Print Friendly Summary
Trial Details
Phase
Gender(s)
Age Range
Location(s)
Recruiting
Treatment Options
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
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
