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.
* 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 (197)
Facility
City
Region
Status
Local Institution - 0012
Birmingham
Alabama
Local Institution - 0229
Phoenix
Arizona
Local Institution - 0193
Tucson
Arizona
Kaiser Permanente
Fontana
California
Local Institution - 0247
La Mesa
California
Local Institution - 0090
La Palma
California
Local Institution - 0124
Los Angeles
California
Local Institution - 0248
Sacramento
California
Local Institution - 0253
San Diego
California
Local Institution - 0128
Santa Barbara
California
Local Institution - 0099
Denver
Colorado
Local Institution - 0054
New Haven
Connecticut
Local Institution - 0249
Coral Springs
Florida
Local Institution - 0010
Gainesville
Florida
Local Institution - 0087
Miami
Florida
Local Institution - 0007
Orlando
Florida
Local Institution - 0242
Plantation
Florida
Local Institution - 0002
Tamarac
Florida
Local Institution - 0165
Tampa
Florida
Local Institution - 0204
Atlanta
Georgia
Local Institution - 0228
Lawrenceville
Georgia
Local Institution - 0147
Lawrenceville
Georgia
Local Institution - 0227
Morton Grove
Illinois
Local Institution - 0077
Schaumburg
Illinois
Local Institution - 0108
Indianapolis
Indiana
Lake Cumberland Rheumatology
New Albany
Indiana
Local Institution - 0225
New Orleans
Louisiana
Local Institution - 0006
Detroit
Michigan
Local Institution - 0179
Eagan
Minnesota
Local Institution - 0177
Summit
New Jersey
Local Institution - 0180
Manhasset
New York
Local Institution - 0085
New York
New York
Local Institution - 0098
Rochester
New York
Local Institution - 0159
The Bronx
New York
Local Institution - 0245
Charlotte
North Carolina
Local Institution - 0155
Charlotte
North Carolina
Local Institution - 0246
Summerville
South Carolina
Local Institution - 0003
Memphis
Tennessee
Local Institution - 0064
Allen
Texas
Local Institution - 0065
Dallas
Texas
+ 157 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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