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

NCT05617677 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IM011-2462022-500699-76
• Study Type: interventional
• Target: 516
• Locations: 22 countries
• Sites: 197

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Immune-mediated Diseases; Active Systemic Lupus Erythematosus; Lupus; SLE; Deucravacitinib; Tyk2; POETYK; POETYK SLE

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response

  At week 52

Secondary Outcomes (15)

• Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response

  At week 52

• Proportion of participants who achieve both SRI(4) and BICLA (dual responders)

  At week 52

• Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score

  At week 52

• Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)

  At week 52

• Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints

  At week 52

Study Arms (2)

Arm 1: Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Arm 2: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Specified dose on specified days

Arm 2: Placebo

Deucravacitinib DRUG

Specified dose on specified days

Arm 1: Deucravacitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (197)

Local Institution - 0012

Birmingham, Alabama, 35205, United States

Location

Local Institution - 0229

Phoenix, Arizona, 85006, United States

Location

Local Institution - 0193

Tucson, Arizona, 85724, United States

Location

Kaiser Permanente

Fontana, California, 92335, United States

Location

Local Institution - 0247

La Mesa, California, 91942, United States

Location

Local Institution - 0090

La Palma, California, 90623, United States

Location

Local Institution - 0124

Los Angeles, California, 90095, United States

Location

Local Institution - 0248

Sacramento, California, 95817, United States

Location

Local Institution - 0253

San Diego, California, 92128, United States

Location

Local Institution - 0128

Santa Barbara, California, 93108, United States

Location

Local Institution - 0099

Denver, Colorado, 80230, United States

Location

Local Institution - 0054

New Haven, Connecticut, 06510, United States

Location

Local Institution - 0249

Coral Springs, Florida, 33065, United States

Location

Local Institution - 0010

Gainesville, Florida, 32610, United States

Location

Local Institution - 0087

Miami, Florida, 33136, United States

Location

Local Institution - 0007

Orlando, Florida, 32806, United States

Location

Local Institution - 0242

Plantation, Florida, 33317, United States

Location

Local Institution - 0002

Tamarac, Florida, 33321, United States

Location

Local Institution - 0165

Tampa, Florida, 33614, United States

Location

Local Institution - 0204

Atlanta, Georgia, 30318, United States

Location

Local Institution - 0228

Lawrenceville, Georgia, 30044, United States

Location

Local Institution - 0147

Lawrenceville, Georgia, 30046, United States

Location

Local Institution - 0227

Morton Grove, Illinois, 60053, United States

Location

Local Institution - 0077

Schaumburg, Illinois, 60195, United States

Location

Local Institution - 0108

Indianapolis, Indiana, 46202, United States

Location

Lake Cumberland Rheumatology

New Albany, Indiana, 47150, United States

Location

Local Institution - 0225

New Orleans, Louisiana, 70121, United States

Location

Local Institution - 0006

Detroit, Michigan, 48202, United States

Location

Local Institution - 0179

Eagan, Minnesota, 55121, United States

Location

Local Institution - 0177

Summit, New Jersey, 07901, United States

Location

Local Institution - 0180

Manhasset, New York, 11030, United States

Location

Local Institution - 0085

New York, New York, 10016, United States

Location

Local Institution - 0098

Rochester, New York, 14642, United States

Location

Local Institution - 0159

The Bronx, New York, 10467, United States

Location

Local Institution - 0245

Charlotte, North Carolina, 28207, United States

Location

Local Institution - 0155

Charlotte, North Carolina, 28211, United States

Location

Local Institution - 0246

Summerville, South Carolina, 29486, United States

Location

Local Institution - 0003

Memphis, Tennessee, 38119, United States

Location

Local Institution - 0064

Allen, Texas, 75013, United States

Location

Local Institution - 0065

Dallas, Texas, 75390, United States

Location

Local Institution - 0088

Fort Worth, Texas, 76177, United States

Location

Local Institution - 0250

Houston, Texas, 77090, United States

Location

Local Institution - 0219

Lubbock, Texas, 79415, United States

Location

Local Institution - 0005

The Woodlands, Texas, 77382, United States

Location

Local Institution - 0009

Roanoke, Virginia, 24016, United States

Location

Local Institution - 0011

Seattle, Washington, 98122, United States

Location

Local Institution - 0139

Seattle, Washington, 98195, United States

Location

Local Institution - 0063

Franklin, Wisconsin, 53132, United States

Location

Local Institution - 0078

Quilmes, Buenos Aires, 1878, Argentina

Location

Local Institution - 0013

Buenos Aires, Buenos Aires F.D., C1121ABE, Argentina

Location

Local Institution - 0020

CABA, Buenos Aires F.D., 1406, Argentina

Location

Local Institution - 0123

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0032

Buenos Aires, 1123, Argentina

Location

Local Institution - 0240

Buenos Aires, C1023AAB, Argentina

Location

Local Institution - 0022

Buenos Aires, C1221ADC, Argentina

Location

Local Institution - 0140

Buenos Aires, CP1280AEB, Argentina

Location

Local Institution - 0138

Córdoba, 5004, Argentina

Location

Local Institution - 0017

Mendoza, 5500, Argentina

Location

Local Institution - 0224

Salvador, Estado de Bahia, 40150-150, Brazil

Location

Local Institution - 0096

Lago Sul, Federal District, 71635580, Brazil

Location

Local Institution - 0042

Belo Horizonte, Minas Gerais, 30150-221, Brazil

Location

Local Institution - 0041

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Local Institution - 0190

Curitiba, Paraná, 80730-150, Brazil

Location

Local Institution - 0181

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

Location

Local Institution - 0185

Campinas, São Paulo, 13015-001, Brazil

Location

Local Institution - 0187

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Local Institution - 0066

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Local Institution - 0191

São Paulo, São Paulo, 04038-002, Brazil

Location

Local Institution - 0186

Rio de Janeiro, 20551-030, Brazil

Location

Local Institution - 0125

São Paulo, 05403-000, Brazil

Location

Local Institution - 0163

Plovdiv, 4000, Bulgaria

Location

Local Institution - 0217

Sofia, 1407, Bulgaria

Location

Local Institution - 0162

Sofia, 1784, Bulgaria

Location

Local Institution - 0126

Calgary, Alberta, T2N 4N1, Canada

Location

Local Institution - 0160

Hamilton, Ontario, L8S 4K1, Canada

Location

Local Institution - 0114

London, Ontario, N6A 4V2, Canada

Location

Local Institution - 0115

Toronto, Ontario, M5T 2S8, Canada

Location

Local Institution - 0136

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0110

Bengbu, Anhui, 233017, China

Location

Local Institution - 0070

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0107

Xiamen, Fujian, 361003, China

Location

Local Institution - 0029

Guangzhou, Guangdong, 510000, China

Location

Local Institution - 0051

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0080

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0037

Shenzhen, Guangdong, 518020, China

Location

Local Institution - 0153

Baoding, Hebei, 071030, China

Location

Local Institution - 0133

Luoyang, Henan, 471003, China

Location

Local Institution - 0023

Zhengzhou, Henan, 450000, China

Location

Local Institution - 0137

Wuhan, Hubei, 430022, China

Location

Local Institution - 0044

Changsha, Hunan, 410008, China

Location

Local Institution - 0021

Zhuzhou, Hunan, 412007, China

Location

Local Institution - 0089

Hohhot, Inner Mongolia, 010050, China

Location

Local Institution - 0129

Changzhou, Jiangsu, 213003, China

Location

Local Institution - 0031

Jiujiang, Jiangxi, 332000, China

Location

Local Institution - 0071

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0117

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0220

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0028

Pingxiang, Jiangxi, 337055, China

Location

Local Institution - 0039

Shenyang, Liaoning, 110001, China

Location

Local Institution - 0092

Shenyang, Liaoning, 110004, China

Location

Local Institution - 0149

Jinan, Shandong, 250001, China

Location

Local Institution - 0079

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0045

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution - 0049

Shanghai, Shanghai Municipality, 200127, China

Location

Local Institution - 0116

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0053

Tianjin, Tianjin Municipality, 300052, China

Location

Local Institution - 0043

Ürümqi, Xinjiang, 830001, China

Location

Local Institution - 0132

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0135

Wenzhou, Zhejiang, 325000, China

Location

Local Institution - 0158

Taiyuan, 030032, China

Location

Local Institution - 0174

Medellín, Antioquia, 050021, Colombia

Location

Local Institution - 0056

Barranquilla, Atlántico, 080002, Colombia

Location

Local Institution - 0086

Bucaramanga, Santander Department, 680003, Colombia

Location

Local Institution - 0100

Bogotá, 110221, Colombia

Location

Local Institution - 0170

Bogotá, 110231, Colombia

Location

Local Institution - 0093

Cali, 760035, Colombia

Location

Local Institution - 0057

Chía, 250001, Colombia

Location

Local Institution - 0150

Strasbourg, Alsace, 67091, France

Location

Local Institution - 0068

Nantes, Loire-Atlantique, 44093 Cedex 1, France

Location

Local Institution - 0173

Le Kremlin-Bicêtre, 94270, France

Location

Local Institution - 0156

Tours, 37032, France

Location

Local Institution - 0109

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Local Institution - 0176

Munich, Bavaria, 80336, Germany

Location

Local Institution - 0146

Dresden, Saxony, 01307, Germany

Location

Local Institution - 0151

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Local Institution - 0195

Chemnitz, 09117, Germany

Location

Local Institution - 0061

Cologne, 50937, Germany

Location

Local Institution - 0120

Erlangen, 91054, Germany

Location

Local Institution - 0111

Planegg, 82152, Germany

Location

Local Institution - 0067

Tuenmen, 999077, Hong Kong

Location

Local Institution - 0213

Vizianagaram, Andhra Pradesh, 0, India

Location

Local Institution - 0200

Ahmedabad, Gujarat, 380015, India

Location

Local Institution - 0243

Surat, Gujarat, 395010, India

Location

Local Institution - 0208

Gurugram, Haryana, 122001, India

Location

Local Institution - 0202

Bengaluru, Karnataka, 560010, India

Location

Local Institution - 0222

Hyderabad, Telangana, 500038, India

Location

Local Institution - 0205

Hyderabad, Telangana, 500082, India

Location

Local Institution - 0119

Manorhamilton, Leitrim, 0, Ireland

Location

Local Institution - 0130

Cork, T12 E8YV, Ireland

Location

Local Institution - 0157

Dublin, D08 E9P6, Ireland

Location

Local Institution - 0172

Dublin, D15 X40D, Ireland

Location

Local Institution - 0084

Rome, Lazio, 00161, Italy

Location

Local Institution - 0095

Milan, Lombardy, 20122, Italy

Location

Local Institution - 0060

Pisa, Tuscany, 56126, Italy

Location

Local Institution - 0097

Padua, Veneto, 35128, Italy

Location

Local Institution - 0069

Brescia, 25123, Italy

Location

Local Institution - 0072

Milan, 20132, Italy

Location

Local Institution - 0154

Naples, 80131, Italy

Location

Local Institution - 0161

Verona, 37134, Italy

Location

Local Institution - 0167

Kaunas, Kaunas County, LT-50161, Lithuania

Location

Local Institution - 0015

Mexicali, Estado de Baja California, 21100, Mexico

Location

Local Institution - 0082

León, Guanajuato, 37000, Mexico

Location

Local Institution - 0024

Zapopan, Jalisco, 45116, Mexico

Location

Local Institution - 0026

Mexico City, Mexico City, 01120, Mexico

Location

Local Institution - 0027

Mexico City, Mexico City, 03720, Mexico

Location

Local Institution - 0016

Mexico City, Mexico City, 06700, Mexico

Location

Local Institution - 0050

Mexico City, Mexico City, 06700, Mexico

Location

Local Institution - 0112

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0018

Chihuahua City, 31000, Mexico

Location

Local Institution - 0083

Puebla City, 72160, Mexico

Location

Local Institution - 0238

Chisinau, Chișinău, MD-2051, Moldova

Location

Local Institution - 0236

Chisinau, 2025, Moldova

Location

Local Institution - 0199

Arequipa, 05154, Peru

Location

Local Institution - 0104

Lima, 15046, Peru

Location

Local Institution - 0122

Lima, 15047, Peru

Location

Local Institution - 0103

Lima, 33, Peru

Location

Local Institution - 0036

Poznan, Greater Poland Voivodeship, 60-218, Poland

Location

Local Institution - 0040

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Local Institution - 0033

Krakow, Lesser Poland Voivodeship, 30-363, Poland

Location

Local Institution - 0034

Nadarzyn, Masovian Voivodeship, 05-830, Poland

Location

Local Institution - 0164

Warsaw, Masovian Voivodeship, 02-118, Poland

Location

Local Institution - 0166

Warsaw, Masovian Voivodeship, 02-637, Poland

Location

Local Institution - 0047

Katowice, Silesian Voivodeship, 40-081, Poland

Location

Local Institution - 0035

Bialystok, 15-707, Poland

Location

Velocity Clinical Research, Lublin

Lublin, 20-362, Poland

Location

Local Institution - 0212

Poznan, 60-702, Poland

Location

Local Institution - 0211

Bełchatów, Łódź Voivodeship, 97-400, Poland

Location

Local Institution - 0203

Caguas, 00725, Puerto Rico

Location

Local Institution - 0252

San Juan, 00909, Puerto Rico

Location

Local Institution - 0197

San Juan, 00917, Puerto Rico

Location

Local Institution - 0148

Bucharest, București, 011053, Romania

Location

Local Institution - 0076

Bucharest, București, 011172, Romania

Location

Local Institution - 0152

Bucharest, București, 014142, Romania

Location

Local Institution - 0141

Bucharest, București, 020125, Romania

Location

Local Institution - 0215

Bucharest, București, 041303, Romania

Location

Local Institution - 0210

Bucharest, București, 30463, Romania

Location

Local Institution - 0142

Craiova, Dolj, 200347, Romania

Location

Local Institution - 0216

Iași, Iaşi, 700127, Romania

Location

Local Institution - 0094

Râmnicu Vâlcea, Vâlcea County, 247065, Romania

Location

Local Institution - 0143

Timișoara, 300766, Romania

Location

Local Institution - 0102

Gwangju, Kwangju-Kwangyǒkshi, 61469, South Korea

Location

Local Institution - 0101

Suwon, Kyǒnggi-do, 16499, South Korea

Location

Local Institution - 0144

Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

Location

Local Institution - 0169

Seoul, 04763, South Korea

Location

Local Institution - 0184

Ankara, 06560, Turkey (Türkiye)

Location

Local Institution - 0168

Istanbul, 34098, Turkey (Türkiye)

Location

Local Institution - 0189

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• Arriens C, Morand EF, Askanase AD, Furie R, van Vollenhoven RF, Tanaka Y, Connors K, Davey M, Young K, Franchin G, Meier R, Shah V, de Oliveria CL, Hobar C. Design of Two Randomized, Placebo-Controlled, Phase 3 Trials of Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in Systemic Lupus Erythematosus. Adv Ther. 2025 Nov;42(11):5830-5844. doi: 10.1007/s12325-025-03299-0. Epub 2025 Sep 8.

  PMID: 40920289 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: January 12, 2023
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): November 13, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (48); MO (2); CA (5); AR (10); FR (4); IN (7); ME (10); KR (4); DE (8); PL (11); BU (3); TU (3); IT (8); PE (4); CN (32); LI (1); PR (3); IE (4); RO (10); CO (7); BR (12); HK (1)