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ACTIVE NOT RECRUITING

NCT05617677

PHASE3

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

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-1)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

516

Start Date

2023-01-12

Completion Date

2028-11-13

Last Updated

2025-12-03

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

Locations (197)

Local Institution - 0012

Birmingham, Alabama, United States

Local Institution - 0229

Phoenix, Arizona, United States

Local Institution - 0193

Tucson, Arizona, United States

Kaiser Permanente

Fontana, California, United States

Local Institution - 0247

La Mesa, California, United States

Local Institution - 0090

La Palma, California, United States

Local Institution - 0124

Los Angeles, California, United States

Local Institution - 0248

Sacramento, California, United States

Local Institution - 0253

San Diego, California, United States

Local Institution - 0128

Santa Barbara, California, United States

Local Institution - 0099

Denver, Colorado, United States

Local Institution - 0054

New Haven, Connecticut, United States

Local Institution - 0249

Coral Springs, Florida, United States

Local Institution - 0010

Gainesville, Florida, United States

Local Institution - 0087

Miami, Florida, United States

Local Institution - 0007

Orlando, Florida, United States

Local Institution - 0242

Plantation, Florida, United States

Local Institution - 0002

Tamarac, Florida, United States

Local Institution - 0165

Tampa, Florida, United States

Local Institution - 0204

Atlanta, Georgia, United States

Local Institution - 0228

Lawrenceville, Georgia, United States

Local Institution - 0147

Lawrenceville, Georgia, United States

Local Institution - 0227

Morton Grove, Illinois, United States

Local Institution - 0077

Schaumburg, Illinois, United States

Local Institution - 0108

Indianapolis, Indiana, United States

Lake Cumberland Rheumatology

New Albany, Indiana, United States

Local Institution - 0225

New Orleans, Louisiana, United States

Local Institution - 0006

Detroit, Michigan, United States

Local Institution - 0179

Eagan, Minnesota, United States

Local Institution - 0177

Summit, New Jersey, United States

Local Institution - 0180

Manhasset, New York, United States

Local Institution - 0085

New York, New York, United States

Local Institution - 0098

Rochester, New York, United States

Local Institution - 0159

The Bronx, New York, United States

Local Institution - 0245

Charlotte, North Carolina, United States

Local Institution - 0155

Charlotte, North Carolina, United States

Local Institution - 0246

Summerville, South Carolina, United States

Local Institution - 0003

Memphis, Tennessee, United States

Local Institution - 0064

Allen, Texas, United States

Local Institution - 0065

Dallas, Texas, United States

Local Institution - 0088

Fort Worth, Texas, United States

Local Institution - 0250

Houston, Texas, United States

Local Institution - 0219

Lubbock, Texas, United States

Local Institution - 0005

The Woodlands, Texas, United States

Local Institution - 0009

Roanoke, Virginia, United States

Local Institution - 0011

Seattle, Washington, United States

Local Institution - 0139

Seattle, Washington, United States

Local Institution - 0063

Franklin, Wisconsin, United States

Local Institution - 0078

Quilmes, Buenos Aires, Argentina

Local Institution - 0013

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 0020

CABA, Buenos Aires F.D., Argentina

Local Institution - 0123

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0032

Buenos Aires, Argentina

Local Institution - 0240

Buenos Aires, Argentina

Local Institution - 0022

Buenos Aires, Argentina

Local Institution - 0140

Buenos Aires, Argentina

Local Institution - 0138

Córdoba, Argentina

Local Institution - 0017

Mendoza, Argentina

Local Institution - 0224

Salvador, Estado de Bahia, Brazil

Local Institution - 0096

Lago Sul, Federal District, Brazil

Local Institution - 0042

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0041

Juiz de Fora, Minas Gerais, Brazil

Local Institution - 0190

Curitiba, Paraná, Brazil

Local Institution - 0181

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0185

Campinas, São Paulo, Brazil

Local Institution - 0187

Ribeirão Preto, São Paulo, Brazil

Local Institution - 0066

São José do Rio Preto, São Paulo, Brazil

Local Institution - 0191

São Paulo, São Paulo, Brazil

Local Institution - 0186

Rio de Janeiro, Brazil

Local Institution - 0125

São Paulo, Brazil

Local Institution - 0163

Plovdiv, Bulgaria

Local Institution - 0217

Sofia, Bulgaria

Local Institution - 0162

Sofia, Bulgaria

Local Institution - 0126

Calgary, Alberta, Canada

Local Institution - 0160

Hamilton, Ontario, Canada

Local Institution - 0114

London, Ontario, Canada

Local Institution - 0115

Toronto, Ontario, Canada

Local Institution - 0136

Rimouski, Quebec, Canada

Local Institution - 0110

Bengbu, Anhui, China

Local Institution - 0070

Beijing, Beijing Municipality, China

Local Institution - 0107

Xiamen, Fujian, China

Local Institution - 0029

Guangzhou, Guangdong, China

Local Institution - 0051

Guangzhou, Guangdong, China

Local Institution - 0080

Guangzhou, Guangdong, China

Local Institution - 0037

Shenzhen, Guangdong, China

Local Institution - 0153

Baoding, Hebei, China

Local Institution - 0133

Luoyang, Henan, China

Local Institution - 0023

Zhengzhou, Henan, China

Local Institution - 0137

Wuhan, Hubei, China

Local Institution - 0044

Changsha, Hunan, China

Local Institution - 0021

Zhuzhou, Hunan, China

Local Institution - 0089

Hohhot, Inner Mongolia, China

Local Institution - 0129

Changzhou, Jiangsu, China

Local Institution - 0031

Jiujiang, Jiangxi, China

Local Institution - 0071

Nanchang, Jiangxi, China

Local Institution - 0117

Nanchang, Jiangxi, China

Local Institution - 0220

Nanchang, Jiangxi, China

Local Institution - 0028

Pingxiang, Jiangxi, China

Local Institution - 0039

Shenyang, Liaoning, China

Local Institution - 0092

Shenyang, Liaoning, China

Local Institution - 0149

Jinan, Shandong, China

Local Institution - 0079

Shanghai, Shanghai Municipality, China

Local Institution - 0045

Shanghai, Shanghai Municipality, China

Local Institution - 0049

Shanghai, Shanghai Municipality, China

Local Institution - 0116

Chengdu, Sichuan, China

Local Institution - 0053

Tianjin, Tianjin Municipality, China

Local Institution - 0043

Ürümqi, Xinjiang, China

Local Institution - 0132

Hangzhou, Zhejiang, China

Local Institution - 0135

Wenzhou, Zhejiang, China

Local Institution - 0158

Taiyuan, China

Local Institution - 0174

Medellín, Antioquia, Colombia

Local Institution - 0056

Barranquilla, Atlántico, Colombia

Local Institution - 0086

Bucaramanga, Santander Department, Colombia

Local Institution - 0100

Bogotá, Colombia

Local Institution - 0170

Bogotá, Colombia

Local Institution - 0093

Cali, Colombia

Local Institution - 0057

Chía, Colombia

Local Institution - 0150

Strasbourg, Alsace, France

Local Institution - 0068

Nantes, Loire-Atlantique, France

Local Institution - 0173

Le Kremlin-Bicêtre, France

Local Institution - 0156

Tours, France

Local Institution - 0109

Tübingen, Baden-Wurttemberg, Germany

Local Institution - 0176

Munich, Bavaria, Germany

Local Institution - 0146

Dresden, Saxony, Germany

Local Institution - 0151

Lübeck, Schleswig-Holstein, Germany

Local Institution - 0195

Chemnitz, Germany

Local Institution - 0061

Cologne, Germany

Local Institution - 0120

Erlangen, Germany

Local Institution - 0111

Planegg, Germany

Local Institution - 0067

Tuenmen, Hong Kong

Local Institution - 0213

Vizianagaram, Andhra Pradesh, India

Local Institution - 0200

Ahmedabad, Gujarat, India

Local Institution - 0243

Surat, Gujarat, India

Local Institution - 0208

Gurugram, Haryana, India

Local Institution - 0202

Bengaluru, Karnataka, India

Local Institution - 0222

Hyderabad, Telangana, India

Local Institution - 0205

Hyderabad, Telangana, India

Local Institution - 0119

Manorhamilton, Leitrim, Ireland

Local Institution - 0130

Cork, Ireland

Local Institution - 0157

Dublin, Ireland

Local Institution - 0172

Dublin, Ireland

Local Institution - 0084

Rome, Lazio, Italy

Local Institution - 0095

Milan, Lombardy, Italy

Local Institution - 0060

Pisa, Tuscany, Italy

Local Institution - 0097

Padova, Veneto, Italy

Local Institution - 0069

Brescia, Italy

Local Institution - 0072

Milan, Italy

Local Institution - 0154

Naples, Italy

Local Institution - 0161

Verona, Italy

Local Institution - 0167

Kaunas, Kaunas County, Lithuania

Local Institution - 0015

Mexicali, Estado de Baja California, Mexico

Local Institution - 0082

León, Guanajuato, Mexico

Local Institution - 0024

Zapopan, Jalisco, Mexico

Local Institution - 0026