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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986165 Dose 1 oral administration
  • Drug: BMS-986165
    Specified dose on specified days
Experimental
BMS-986165 Dose 2 oral administration
  • Drug: BMS-986165
    Specified dose on specified days
Experimental
BMS-986165 Dose 3 oral administration
  • Drug: BMS-986165
    Specified dose on specified days
Placebo Comparator
Placebo oral administration
  • Other: Placebo
    Specified dose on specified days

More Details

Status
Completed
Sponsor
Bristol-Myers Squibb

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.