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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: BMS-986165; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03252587

IM011-021

2017-001203-79 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 363 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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363 participants in 4 patient groups, including a placebo group

BMS-986165 Dose 1 oral administration

Experimental group

Treatment:

Drug: BMS-986165

BMS-986165 Dose 2 oral administration

Experimental group

Treatment:

Drug: BMS-986165

BMS-986165 Dose 3 oral administration

Experimental group

Treatment:

Drug: BMS-986165

Placebo oral administration

Placebo Comparator group

Treatment:

Other: Placebo