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

NCT05620407 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IM011-2472022-500700-22
• Study Type: interventional
• Target: 513
• Locations: 22 countries
• Sites: 180

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 oral corticosteroid (OCS) ≥ 7.5 mg/day of prednisone at baseline who are receiving ≤ 5 mg/day of prednisone at Week (Wk) 40 which is maintained through Wk52 and who achieve an SRI(4) response at Wk52

  At week 52

Study Arms (2)

Arm 1: Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Arm 2: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Arm 1: Deucravacitinib

Placebo OTHER

Specified dose on specified days

Arm 2: Placebo

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.
• In Japan only: Participants with positive result of β - D-glucan assay.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (180)

Local Institution - 0063

La Jolla, California, 92037, United States

Location

Local Institution - 0241

La Mesa, California, 91942, United States

Location

Local Institution - 0242

San Diego, California, 92128, United States

Location

Local Institution - 0143

San Leandro, California, 94578, United States

Location

Local Institution - 0147

Santa Monica, California, 90404, United States

Location

Local Institution - 0213

Clearwater, Florida, 33765, United States

Location

Local Institution - 0059

Jacksonville, Florida, 32256, United States

Location

Local Institution - 0075

Margate, Florida, 33063, United States

Location

Local Institution - 0007

Oakland Park, Florida, 33334, United States

Location

Local Institution - 0239

Plant City, Florida, 33160, United States

Location

Emory University School of Medicine- Grady Campus

Atlanta, Georgia, 30303, United States

Location

Local Institution - 0137

Marietta, Georgia, 30060, United States

Location

Local Institution - 0089

Orland Park, Illinois, 60467, United States

Location

Local Institution - 0041

Skokie, Illinois, 60076, United States

Location

Local Institution - 0231

New Orleans, Louisiana, 70112, United States

Location

Local Institution - 0060

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0056

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0084

Worcester, Massachusetts, 01605, United States

Location

Local Institution - 0152

Grand Blanc, Michigan, 48439, United States

Location

Local Institution - 0072

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0216

Las Vegas, Nevada, 89102, United States

Location

Local Institution - 0165

Paramus, New Jersey, 07652, United States

Location

Local Institution - 0069

Brooklyn, New York, 11201, United States

Location

Local Institution - 0217

Great Neck, New York, 11021, United States

Location

Local Institution - 0150

New York, New York, 10021, United States

Location

Local Institution - 0102

New York, New York, 10032, United States

Location

Local Institution - 0145

Syracuse, New York, 13210, United States

Location

Local Institution - 0178

Charlotte, North Carolina, 28210, United States

Location

Local Institution - 0005

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0043

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 0205

Pittsburgh, Pennsylvania, 15224, United States

Location

Local Institution - 0081

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0225

Florence, South Carolina, 29501, United States

Location

Local Institution - 0002

Jackson, Tennessee, 38305, United States

Location

Local Institution - 0001

Colleyville, Texas, 76034, United States

Location

Local Institution - 0164

El Paso, Texas, 79902, United States

Location

Local Institution - 0169

Katy, Texas, 77494, United States

Location

Local Institution - 0201

Temple, Texas, 76508, United States

Location

Local Institution - 0133

Danville, Virginia, 24541, United States

Location

Local Institution - 0146

Ciudad de Buenos Aires, Buenos Aires, 1180, Argentina

Location

Local Institution - 0088

La Plata, Buenos Aires, 1900, Argentina

Location

Local Institution - 0078

Pergamino, Buenos Aires, B2700, Argentina

Location

Local Institution - 0125

Pilar, Buenos Aires, 1629, Argentina

Location

Local Institution - 0020

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

Local Institution - 0136

San Miguel, Buenos Aires, 1663, Argentina

Location

Local Institution - 0018

Quilmes, Buenos Aires F.D., 1879, Argentina

Location

Local Institution - 0013

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

Location

Local Institution - 0027

San Miguel de Tucumán, Tucumán Province, T4000, Argentina

Location

Local Institution - 0179

Liverpool, New South Wales, 2170, Australia

Location

Local Institution - 0182

Paramatta, New South Wales, 2150, Australia

Location

Local Institution - 0066

Maroochydore, Queensland, 4558, Australia

Location

Local Institution - 0177

Ivanhoe, Victoria, 3079, Australia

Location

Local Institution - 0129

Victoria Park, Western Australia, 6100, Australia

Location

Local Institution - 0160

Vitória, Espírito Santo, 29055450, Brazil

Location

Local Institution - 0028

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

Local Institution - 0154

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Local Institution - 0023

Porto Alegre, Rio Grande do Sul, 90560032, Brazil

Location

Local Institution - 0230

Porto Velho, Rondônia, 76801-098, Brazil

Location

Local Institution - 0175

Barretos, São Paulo, 14784400, Brazil

Location

Local Institution - 0115

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Local Institution - 0087

Rio de Janeiro, 22061-080, Brazil

Location

Local Institution - 0161

São Paulo, 01327-001, Brazil

Location

Local Institution - 0062

São Paulo, 01409-901, Brazil

Location

Local Institution - 0190

São Paulo, 04266-010, Brazil

Location

Local Institution - 0163

Sofia, Sofia (stolitsa), 1463, Bulgaria

Location

Local Institution - 0158

Plovdiv, 4001, Bulgaria

Location

Local Institution - 0159

Rousse, 7002, Bulgaria

Location

Local Institution - 0139

La Serena, Coquimbo Region, 1720430, Chile

Location

Local Institution - 0220

Santiago, Santiago Metropolitan, 7500571, Chile

Location

Local Institution - 0101

Santiago, Santiago Metropolitan, 7500710, Chile

Location

Local Institution - 0183

Santiago, Santiago Metropolitan, 7501126, Chile

Location

Local Institution - 0140

Santiago, Santiago Metropolitan, 8330032, Chile

Location

Local Institution - 0203

Santiago, Santiago Metropolitan, 8380465, Chile

Location

Local Institution - 0153

Santiago, 7550000, Chile

Location

Local Institution - 0174

Ostrava, Ostrava Město, 70300, Czechia

Location

Local Institution - 0036

Prague, 12850, Czechia

Location

Local Institution - 0123

Athens, Attikí (Region), 115 27, Greece

Location

Local Institution - 0116

Athens, Attikí, 11527, Greece

Location

Local Institution - 0138

Larissa, Thessalía, 411 10, Greece

Location

Local Institution - 0057

Pécs, Baranya, 7632, Hungary

Location

Local Institution - 0035

Gyula, Bekes County, 5700, Hungary

Location

Local Institution - 0134

Szeged, Csongrád megye, 6725, Hungary

Location

Local Institution - 0034

Veszprém, Veszprém City, 8200, Hungary

Location

Local Institution - 0234

Ahmedabad, Gujarat, 380013, India

Location

Local Institution - 0233

Ahmedabad, Gujarat, 382443, India

Location

Local Institution - 0191

Hubli, Karnataka, 580021, India

Location

Local Institution - 0222

Mysore, Karnataka, 570004, India

Location

Local Institution - 0229

Nagpur, Maharashtra, 440012, India

Location

Local Institution - 0210

Vellore, Tamil Nadu, 632 004, India

Location

Local Institution - 0235

Hyderabad, Telangana, 500016, India

Location

Local Institution - 0199

Secundarabad, Telangana, 500003, India

Location

Local Institution - 0053

Nagoya, Aichi-ken, 457-8511, Japan

Location

Local Institution - 0156

Nagoya, Aichi-ken, 466-8560, Japan

Location

Local Institution - 0083

Toyoake, Aichi-ken, 470-1192, Japan

Location

Local Institution - 0047

Chiba, Chiba, 260-8712, Japan

Location

Local Institution - 0086

Eiheiji-cho,Yoshida-gun, Fukui, 910-1193, Japan

Location

Local Institution - 0117

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Local Institution - 0082

Asahikawa, Hokkaido, 0708644, Japan

Location

Local Institution - 0048

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0162

Kita, Kagawa-ken, 761-0701, Japan

Location

Local Institution - 0111

Sagamihara, Kanagawa, 252-0375, Japan

Location

Local Institution - 0157

Yokohama, Kanagawa, 236-0004, Japan

Location

Local Institution - 0021

Sendai, Miyagi, 980-8574, Japan

Location

Local Institution - 0113

Sasebo, Nagasaki, 8571195, Japan

Location

Local Institution - 0022

Kawagoe, Saitama, 350-8550, Japan

Location

Local Institution - 0171

Shimotsuga, Tochigi, 321-0293, Japan

Location

Local Institution - 0173

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Local Institution - 0046

Bunkyo-ku, Tokyo, 1138431, Japan

Location

Local Institution - 0045

Meguro-ku, Tokyo, 1538515, Japan

Location

Local Institution - 0064

Shinjyuku-ku, Tokyo, 162-8655, Japan

Location

Local Institution - 0226

Toyoma, Toyama, 930-0194, Japan

Location

Local Institution - 0227

Fukuoka, 812-8582, Japan

Location

Local Institution - 0050

Fukushima, 960-1295, Japan

Location

Local Institution - 0167

Gifu, 501-1112, Japan

Location

Local Institution - 0126

Nagasaki, 852-8501, Japan

Location

Local Institution - 0131

Niigata, 951-8520, Japan

Location

Local Institution - 0085

Okayama, 700-8558, Japan

Location

Local Institution - 0108

Osaka, 545-8586, Japan

Location

Local Institution - 0054

Tokyo, 104-8560, Japan

Location

Local Institution - 0051

Tokyo, 1608582, Japan

Location

Local Institution - 0148

Wakayama, 641-8510, Japan

Location

Local Institution - 0107

Torreón, Coahuila, 27000, Mexico

Location

Local Institution - 0009

León, Guanajuato, 37160, Mexico

Location

Local Institution - 0077

Guadajalara, Jalisco, 44600, Mexico

Location

Local Institution - 0026

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0024

Mexico City, Mexico City, 03100, Mexico

Location

Local Institution - 0011

Mexico City, Mexico City, 06760, Mexico

Location

Local Institution - 0010

Cuernavaca, Morelos, 62290, Mexico

Location

Local Institution - 0124

Monterrey, Nuevo León, 64020, Mexico

Location

Local Institution - 0106

Chihuahua City, 31350, Mexico

Location

Local Institution - 0074

Oaxaca City, 68000, Mexico

Location

Local Institution - 0208

Lima, 15046, Peru

Location

Local Institution - 0176

Lima, 15072, Peru

Location

Local Institution - 0118

Lima, 15419, Peru

Location

Local Institution - 0121

Lima, LIMA 31, Peru

Location

Local Institution - 0017

Poznan, Greater Poland Voivodeship, 61-545, Poland

Location

Local Institution - 0029

Krakow, Lesser Poland Voivodeship, 30-727, Poland

Location

Local Institution - 0186

Lublin, Lublin Voivodeship, 20-607, Poland

Location

Local Institution - 0219

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Local Institution - 0185

Warsaw, Masovian Voivodeship, 02-672, Poland

Location

Local Institution - 0119

Warsaw, Masovian Voivodeship, 03-291, Poland

Location

Local Institution - 0224

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

Local Institution - 0016

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

Local Institution - 0071

Szczecin, 71-252, Poland

Location

Local Institution - 0014

Warsaw, 00-874, Poland

Location

Local Institution - 0031

Wroclaw, 52-416, Poland

Location

Local Institution - 0187

Lodz, Łódź Voivodeship, 90-368, Poland

Location

Local Institution - 0105

Lisbon, Lisbon District, 1649-035, Portugal

Location

Local Institution - 0109

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Local Institution - 0144

Lisbon, 1050-034, Portugal

Location

Local Institution - 0073

Lisbon, 2720-276, Portugal

Location

Local Institution - 0240

Caguas, 00725, Puerto Rico

Location

Local Institution - 0194

San Juan, 00909, Puerto Rico

Location

Local Institution - 0135

Singapore, 169608, Singapore

Location

Local Institution - 0127

Singapore, 529889, Singapore

Location

Local Institution - 0151

Mérida, Badajoz, 06800, Spain

Location

Local Institution - 0038

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0110

Bilbao, Basque Country, 48013, Spain

Location

Local Institution - 0061

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0103

Cordoba, Madrid, 14004, Spain

Location

Local Institution - 0052

Seville, 41010, Spain

Location

Local Institution - 0058

Valencia, 46026, Spain

Location

Local Institution - 0067

Valladolid, 47012, Spain

Location

Local Institution - 0094

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Local Institution - 0040

Taichung, Taichung, 402, Taiwan

Location

Local Institution - 0065

Taichung, 404332, Taiwan

Location

Local Institution - 0114

Taichung, 407, Taiwan

Location

Local Institution - 0039

Tainan, 71004, Taiwan

Location

Local Institution - 0181

Taipei, 10002, Taiwan

Location

Local Institution - 0122

Taipei, 11217, Taiwan

Location

Local Institution - 0212

Bangkok, Bangkok, 10400, Thailand

Location

Local Institution - 0211

Bangkok, Bangkok, 10700, Thailand

Location

Local Institution - 0184

Ankara, 06230, Turkey (Türkiye)

Location

Local Institution - 0166

Antalya, 07059, Turkey (Türkiye)

Location

Local Institution - 0188

Gaziantep, 27090, Turkey (Türkiye)

Location

Local Institution - 0223

London, England, NW32QG, United Kingdom

Location

Local Institution - 0090

London, Greater London, SE5 9RS, United Kingdom

Location

Local Institution - 0091

London, London, City of, SE1 9RT, United Kingdom

Location

Local Institution - 0168

Central Middlesbrough, Middlesbrough, TS4 3BW, United Kingdom

Location

Local Institution - 0130

Oxford, OX3 7LD, United Kingdom

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: January 12, 2023
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): November 13, 2028
• Last Updated: December 2, 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

PR (2); ES (8); ME (10); IN (8); PL (12); CL (7); PT (4); SG (2); CZ (2); TW (7); GB (5); BR (11); BU (3); TH (2); TU (3); AR (9); US (39); JP (30); PE (4); HU (4); GR (3); AU (5)