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Clinical Trials in the UK / NCT05620407
Active, not recruiting Phase 3

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

NCT05620407 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2023-01-12
Last updated
2025-12-02

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

DeucravacitinibPlacebo

Deucravacitinib: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

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)

Trial sites (180)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT05620407 on ClinicalTrials.gov ↗ ← All trials in the UK