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Clinical Trials in India / NCT05617677
Active, not recruiting Phase 3

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

NCT05617677 · tracked via the Priya Life Science India tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2023-01-12
Last updated
2025-12-03

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. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (197)

FacilityCityRegionStatus
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.

More Bristol-Myers Squibb trials in India

Other trials for the same condition

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 NCT05617677 on ClinicalTrials.gov ↗ ← All trials in India