A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria
* Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
* Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
* One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.
* Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.
* Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
* At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
* Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.
Exclusion Criteria
* Diagnosis of drug-induced SLE rather than idiopathic SLE.
* Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
* Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
* Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
* History of congenital or acquired immunodeficiency.
* Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
* Taking more than 1 immunosuppressant at screening.
* In Japan only: Participants with positive result of β - D-glucan assay.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response — At week 52
Trial sites (180)
Facility
City
Region
Status
Local Institution - 0063
La Jolla
California
Local Institution - 0241
La Mesa
California
Local Institution - 0242
San Diego
California
Local Institution - 0143
San Leandro
California
Local Institution - 0147
Santa Monica
California
Local Institution - 0213
Clearwater
Florida
Local Institution - 0059
Jacksonville
Florida
Local Institution - 0075
Margate
Florida
Local Institution - 0007
Oakland Park
Florida
Local Institution - 0239
Plant City
Florida
Emory University School of Medicine- Grady Campus
Atlanta
Georgia
Local Institution - 0137
Marietta
Georgia
Local Institution - 0089
Orland Park
Illinois
Local Institution - 0041
Skokie
Illinois
Local Institution - 0231
New Orleans
Louisiana
Local Institution - 0060
Boston
Massachusetts
Local Institution - 0056
Boston
Massachusetts
Local Institution - 0084
Worcester
Massachusetts
Local Institution - 0152
Grand Blanc
Michigan
Local Institution - 0072
Rochester
Minnesota
Local Institution - 0216
Las Vegas
Nevada
Local Institution - 0165
Paramus
New Jersey
Local Institution - 0069
Brooklyn
New York
Local Institution - 0217
Great Neck
New York
Local Institution - 0150
New York
New York
Local Institution - 0102
New York
New York
Local Institution - 0145
Syracuse
New York
Local Institution - 0178
Charlotte
North Carolina
Local Institution - 0005
Cleveland
Ohio
Local Institution - 0043
Oklahoma City
Oklahoma
Local Institution - 0205
Pittsburgh
Pennsylvania
Local Institution - 0081
Charleston
South Carolina
Local Institution - 0225
Florence
South Carolina
Local Institution - 0002
Jackson
Tennessee
Local Institution - 0001
Colleyville
Texas
Local Institution - 0164
El Paso
Texas
Local Institution - 0169
Katy
Texas
Local Institution - 0201
Temple
Texas
Local Institution - 0133
Danville
Virginia
Local Institution - 0146
Ciudad de Buenos Aires
Buenos Aires
+ 140 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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