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ACTIVE NOT RECRUITING

NCT05620407

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

513

Start Date

2023-01-12

Completion Date

2028-11-13

Last Updated

2025-12-02

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus

Interventions

DRUG

Deucravacitinib

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

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.

Locations (180)

Local Institution - 0063

La Jolla, California, United States

Local Institution - 0241

La Mesa, California, United States

Local Institution - 0242

San Diego, California, United States

Local Institution - 0143

San Leandro, California, United States

Local Institution - 0147

Santa Monica, California, United States

Local Institution - 0213

Clearwater, Florida, United States

Local Institution - 0059

Jacksonville, Florida, United States

Local Institution - 0075

Margate, Florida, United States

Local Institution - 0007

Oakland Park, Florida, United States

Local Institution - 0239

Plant City, Florida, United States

Emory University School of Medicine- Grady Campus

Atlanta, Georgia, United States

Local Institution - 0137

Marietta, Georgia, United States

Local Institution - 0089

Orland Park, Illinois, United States

Local Institution - 0041

Skokie, Illinois, United States

Local Institution - 0231

New Orleans, Louisiana, United States

Local Institution - 0060

Boston, Massachusetts, United States

Local Institution - 0056

Boston, Massachusetts, United States

Local Institution - 0084

Worcester, Massachusetts, United States

Local Institution - 0152

Grand Blanc, Michigan, United States

Local Institution - 0072

Rochester, Minnesota, United States

Local Institution - 0216

Las Vegas, Nevada, United States

Local Institution - 0165

Paramus, New Jersey, United States

Local Institution - 0069

Brooklyn, New York, United States

Local Institution - 0217

Great Neck, New York, United States

Local Institution - 0150

New York, New York, United States

Local Institution - 0102

New York, New York, United States

Local Institution - 0145

Syracuse, New York, United States

Local Institution - 0178

Charlotte, North Carolina, United States

Local Institution - 0005

Cleveland, Ohio, United States

Local Institution - 0043

Oklahoma City, Oklahoma, United States

Local Institution - 0205

Pittsburgh, Pennsylvania, United States

Local Institution - 0081

Charleston, South Carolina, United States

Local Institution - 0225

Florence, South Carolina, United States

Local Institution - 0002

Jackson, Tennessee, United States

Local Institution - 0001

Colleyville, Texas, United States

Local Institution - 0164

El Paso, Texas, United States

Local Institution - 0169

Katy, Texas, United States

Local Institution - 0201

Temple, Texas, United States

Local Institution - 0133

Danville, Virginia, United States

Local Institution - 0146

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0088

La Plata, Buenos Aires, Argentina

Local Institution - 0078

Pergamino, Buenos Aires, Argentina

Local Institution - 0125

Pilar, Buenos Aires, Argentina

Local Institution - 0020

San Juan Bautista, Buenos Aires, Argentina

Local Institution - 0136

San Miguel, Buenos Aires, Argentina

Local Institution - 0018

Quilmes, Buenos Aires F.D., Argentina

Local Institution - 0013

SAN M. de Tucuman, Tucumán Province, Argentina

Local Institution - 0027

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0179

Liverpool, New South Wales, Australia

Local Institution - 0182

Paramatta, New South Wales, Australia

Local Institution - 0066

Maroochydore, Queensland, Australia

Local Institution - 0177

Ivanhoe, Victoria, Australia

Local Institution - 0129

Victoria Park, Western Australia, Australia

Local Institution - 0160

Vitória, Espírito Santo, Brazil

Local Institution - 0028

Lajeado, Rio Grande do Sul, Brazil

Local Institution - 0154

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0023

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0230

Porto Velho, Rondônia, Brazil

Local Institution - 0175

Barretos, São Paulo, Brazil

Local Institution - 0115

São Bernardo do Campo, São Paulo, Brazil

Local Institution - 0087

Rio de Janeiro, Brazil

Local Institution - 0161

São Paulo, Brazil

Local Institution - 0062

São Paulo, Brazil

Local Institution - 0190

São Paulo, Brazil

Local Institution - 0163

Sofia, Sofia (stolitsa), Bulgaria

Local Institution - 0158

Plovdiv, Bulgaria

Local Institution - 0159

Rousse, Bulgaria

Local Institution - 0139

La Serena, Coquimbo Region, Chile

Local Institution - 0220