A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

NCT04908202 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: IM011-0542023-506256-25U1111-1259-9443
• Study Type: interventional
• Target: 670
• Locations: 21 countries
• Sites: 183

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Conditions

Psoriatic Arthritis

Keywords

Biologic-Naive; BMS-986165; Deucravacitinib; Disease-modifying Anti-rheumatic Drugs; DMARDs; Joint Disease; Psoriatic Arthritis; PsA

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With ACR 20 Response at Week 16

  The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

  Week 16

Secondary Outcomes (58)

• Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16

  Baseline and Week 16

• Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16

  Baseline and Week 16

• Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline

  Week 16

• Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16

  Baseline and Week 16

• Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16

  Week 16

Study Arms (2)

Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165

Deucravacitinib

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
• Meets the Classification Criteria for Psoriatic Arthritis at Screening.
• Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.
• Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1.
• Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
• ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
• Must have completed the week 52 treatment for the optional open-label long-term extension period.

You may not qualify if:

• Nonplaque psoriasis at screening or day 1.
• Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
• History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
• Active fibromyalgia.
• Received an approved or investigational biologic therapy for the treatment of PsA or PsO.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (183)

Local Institution - 0197

Gilbert, Arizona, 85297, United States

Location

Local Institution - 0188

Jonesboro, Arkansas, 72401, United States

Location

Local Institution - 0168

Fontana, California, 92335, United States

Location

Local Institution - 0199

Fullerton, California, 92835, United States

Location

Local Institution - 0038

Sacramento, California, 95815, United States

Location

Cohen Medical Centers

Thousand Oaks, California, 91360, United States

Location

Local Institution - 0170

Denver, Colorado, 80230, United States

Location

Local Institution - 0195

Clearwater, Florida, 33765, United States

Location

Local Institution - 0272

Margate, Florida, 33063, United States

Location

Local Institution - 0082

Miami Lakes, Florida, 33014, United States

Location

Local Institution - 0171

Gainesville, Georgia, 30501, United States

Location

Local Institution - 0087

Boise, Idaho, 83702, United States

Location

Local Institution - 0080

Chicago, Illinois, 60640, United States

Location

Local Institution - 0177

Orland Park, Illinois, 60467, United States

Location

Local Institution - 0178

Schaumburg, Illinois, 60195, United States

Location

Local Institution - 0083

Lexington, Kentucky, 40504, United States

Location

Local Institution - 0042

Hagerstown, Maryland, 21740, United States

Location

Local Institution - 0198

Detroit, Michigan, 48202, United States

Location

Local Institution - 0201

Springfield, Missouri, 65807, United States

Location

Local Institution - 0268

Kalispell, Montana, 59901, United States

Location

Local Institution - 0186

Voorhees Township, New Jersey, 08043, United States

Location

University Hospitals Cleveland Medical Center-Dermatology

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0028

Middleburg Heights, Ohio, 44130, United States

Location

Local Institution - 0179

Perrysburg, Ohio, 43551, United States

Location

Local Institution - 0182

Oklahoma City, Oklahoma, 73102, United States

Location

Local Institution - 0185

Corvallis, Oregon, 97330, United States

Location

Local Institution - 0175

Greenville, South Carolina, 29601, United States

Location

Local Institution - 0036

Jackson, Tennessee, 38305, United States

Location

Local Institution - 0172

Allen, Texas, 75013, United States

Location

Local Institution - 0189

Amarillo, Texas, 79124, United States

Location

Local Institution - 0032

Dallas, Texas, 75231, United States

Location

Local Institution - 0273

Bothell, Washington, 98021, United States

Location

Local Institution - 0181

Beckley, West Virginia, 25801, United States

Location

Local Institution - 0213

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1111, Argentina

Location

Local Institution - 0054

La Plata, Buenos Aires, 1900, Argentina

Location

Local Institution - 0215

Quilmes, Buenos Aires, 1878, Argentina

Location

Local Institution - 0046

Córdoba, Córdoba Province, X5004CDT, Argentina

Location

Local Institution - 0196

Rosario, Santa Fe Province, S2000, Argentina

Location

Local Institution - 0047

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0194

Buenos Aires, 1426, Argentina

Location

Local Institution - 0169

Buenos Aires, 1428, Argentina

Location

Local Institution - 0192

Buenos Aires, C1427CCL, Argentina

Location

Local Institution - 0193

Mendoza, 5500, Argentina

Location

Local Institution - 0220

Phillip, Australian Capital Territory, 2606, Australia

Location

Local Institution - 0137

Botany, New South Wales, 2019, Australia

Location

Local Institution - 0133

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0132

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 0211

Hobart, Tasmania, 7000, Australia

Location

Local Institution - 0136

Camberwell, Victoria, 3142, Australia

Location

Local Institution - 0109

Vitória, Espírito Santo, 29055450, Brazil

Location

Local Institution - 0001

Salvador, Estado de Bahia, 40150-150, Brazil

Location

Local Institution - 0002

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

Location

Local Institution - 0219

Curitiba, Paraná, 80030110, Brazil

Location

Local Institution - 0214

Curitiba, Paraná, 80440-080, Brazil

Location

Local Institution - 0005

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Local Institution - 0108

Santo André, São Paulo, 09060-870, Brazil

Location

Local Institution - 0255

Plovdiv, Plovdiv, 4002, Bulgaria

Location

Local Institution - 0248

Sofia, Sofia (stolitsa), 1463, Bulgaria

Location

Local Institution - 0253

Burgas, 8000, Bulgaria

Location

Local Institution - 0249

Plovdiv, 4000, Bulgaria

Location

Local Institution - 0267

Plovdiv, 4000, Bulgaria

Location

Local Institution - 0246

Plovdiv, 4001, Bulgaria

Location

Local Institution - 0247

Plovdiv, 4001, Bulgaria

Location

Local Institution - 0245

Sofia, 1505, Bulgaria

Location

Local Institution - 0259

Sofia, 1784, Bulgaria

Location

Local Institution - 0250

Varna, 9000, Bulgaria

Location

Local Institution - 0226

Santiago, Santiago Metropolitan, 0, Chile

Location

Local Institution - 0099

Santiago, Santiago Metropolitan, 7500571, Chile

Location

Local Institution - 0073

Santiago, Santiago Metropolitan, 7501126, Chile

Location

Local Institution - 0222

Santiago, Santiago Metropolitan, 7510047, Chile

Location

Local Institution - 0111

Santiago, Santiago Metropolitan, 7640881, Chile

Location

Local Institution - 0261

Viña del Mar, Valparaiso, 2531172, Chile

Location

Local Institution - 0149

Hefei, Anhui, 230071, China

Location

Local Institution - 0159

Beijing, Beijing Municipality, 100005, China

Location

Local Institution - 0190

Chongqing, Chongqing Municipality, 400010, China

Location

Local Institution - 0147

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0143

Shenzhen, Guangdong, 518020, China

Location

Local Institution - 0150

Dalian, Liaoning, 116000, China

Location

Local Institution - 0146

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution - 0145

Yiwu, Zhejiang, 322000, China

Location

Local Institution - 0071

Bucaramanga, Santander Department, 680003, Colombia

Location

Local Institution - 0072

Barranquilla, 080020, Colombia

Location

Local Institution - 0069

Bogotá, 110221, Colombia

Location

Local Institution - 0063

Bogotá, 111156, Colombia

Location

Local Institution - 0070

Cali, 760042, Colombia

Location

Local Institution - 0094

Medellín, 050021, Colombia

Location

Local Institution - 0064

Medellín, 050034, Colombia

Location

Local Institution - 0065

Zipaquirá, 250252, Colombia

Location

Local Institution - 0225

Prague, Praha 5, 150 06, Czechia

Location

Local Institution - 0269

Uherské Hradiště, Zlín, 68601, Czechia

Location

Local Institution - 0202

Zlín, Zlín, 760 01, Czechia

Location

Local Institution - 0018

Ostrava, 722 00, Czechia

Location

Local Institution - 0208

Pardubice, 530 02, Czechia

Location

Local Institution - 0097

Prague, 12850, Czechia

Location

Local Institution - 0017

Prague, 130 00, Czechia

Location

Local Institution - 0013

Helsinki, 00290, Finland

Location

Local Institution - 0089

Kuopio, 70100, Finland

Location

Local Institution - 0119

Turku, FI-20521, Finland

Location

Local Institution - 0077

Chambray-lès-Tours, 37170, France

Location

Local Institution - 0075

Montpellier, 34295, France

Location

Local Institution - 0074

Paris, 75010, France

Location

Local Institution - 0270

Gyula, Bekes County, 5700, Hungary

Location

Local Institution - 0049

Székesfehérvár, Fejér, 8000, Hungary

Location

Local Institution - 0023

Budapest, 1027, Hungary

Location

Local Institution - 0142

Budapest, 1027, Hungary

Location

Local Institution - 0026

Budapest, 1033, Hungary

Location

Local Institution - 0025

Budapest, 1036, Hungary

Location

Local Institution - 0203

Budapest, 1036, Hungary

Location

Local Institution - 0068

Zalaegerszeg, 8900, Hungary

Location

Local Institution - 0104

Manorhamilton, Leitrim, F91 X012, Ireland

Location

Local Institution - 0101

Dublin, 4, Ireland

Location

Local Institution - 0102

Dublin, D15 X40D, Ireland

Location

Local Institution - 0103

Galway, H91 TY80, Ireland

Location

Local Institution - 0066

Genova, 16132, Italy

Location

Local Institution - 0062

Pavia, 27100, Italy

Location

Local Institution - 0096

Udine, 33100, Italy

Location

Local Institution - 0058

Verona, 37134, Italy

Location

Local Institution - 0056

Saltillo, Coahuila, 25050, Mexico

Location

Local Institution - 0254

Guadalajara, Jalisco, 44610, Mexico

Location

Local Institution - 0057

Mexico City, Mexico City, 06720, Mexico

Location

Local Institution - 0128

San Luis Potosí City, San Luis Potosí, 78200, Mexico

Location

Local Institution - 0061

Mérida, Yucatán, 97070, Mexico

Location

Local Institution - 0212

Mérida, Yucatán, 97070, Mexico

Location

Local Institution - 0060

Chihuahua City, 31000, Mexico

Location

Local Institution - 0209

Mexico City, 14080, Mexico

Location

Local Institution - 0095

Veracruz, 91900, Mexico

Location

Local Institution - 0231

Dąbrówka, Greater Poland Voivodeship, 62-069, Poland

Location

Local Institution - 0229

Krakow, Lesser Poland Voivodeship, 30-149, Poland

Location

Local Institution - 0206

Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland

Location

Local Institution - 0244

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

Local Institution - 0232

Lublin, Lublin Voivodeship, 20-607, Poland

Location

Local Institution - 0230

Świdnik, Lublin Voivodeship, 21-040, Poland

Location

Local Institution - 0233

Nadarzyn, Masovian Voivodeship, 05-830, Poland

Location

Local Institution - 0235

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Local Institution - 0243

Warsaw, Masovian Voivodeship, 02-672, Poland

Location

Local Institution - 0236

Wołomin, Masovian Voivodeship, 05-200, Poland

Location

Local Institution - 0257

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Local Institution - 0234

Gdynia, Pomeranian Voivodeship, 31-338, Poland

Location

Local Institution - 0241

Częstochowa, Silesian Voivodeship, 42-202, Poland

Location

Local Institution - 0252

Katowice, Silesian Voivodeship, 40-040, Poland

Location

Local Institution - 0114

Bialystok, 15-351, Poland

Location

Local Institution - 0126

Krakow, 30-002, Poland

Location

Local Institution - 0127

Krakow, 30-033, Poland

Location

Local Institution - 0140

Krakow, 31-501, Poland

Location

Local Institution - 0162

Olsztyn, 10-117, Poland

Location

Local Institution - 0113

Poznan, 60-218, Poland

Location

Local Institution - 0239

Poznan, 60-702, Poland

Location

Local Institution - 0112

Poznan, 60-773, Poland

Location

Local Institution - 0204

Warsaw, 00-874, Poland

Location

Local Institution - 0205

Warsaw, 02-118, Poland

Location

Local Institution - 0125

Warsaw, 03-291, Poland

Location

Local Institution - 0210

Wroclaw, 52-210, Poland

Location

Local Institution - 0238

Lodz, Łódź Voivodeship, 90-368, Poland

Location

Local Institution - 0090

Bucharest, Bucharest, 011172, Romania

Location

Local Institution - 0266

Bucharest, Bucharest, 020125, Romania

Location

Local Institution - 0010

Râmnicu Vâlcea, Vâlcea County, 247065, Romania

Location

Local Institution - 0012

Brasov, 500283, Romania

Location

Local Institution - 0167

Bucharest, 011025, Romania

Location

Local Institution - 0260

Bucharest, 014142, Romania

Location

Local Institution - 0263

Bucharest, 030463, Romania

Location

Local Institution - 0184

Bucharest, 11057, Romania

Location

Local Institution - 0011

Cluj-Napoca, 400006, Romania

Location

Local Institution - 0258

Craiova, 200347, Romania

Location

Local Institution - 0262

Iași, 700127, Romania

Location

Local Institution - 0265

Iași, 700661, Romania

Location

Local Institution - 0264

Iași, 700714, Romania

Location

Local Institution - 0091

Timișoara, 300778, Romania

Location

Local Institution

Kemerovo, 650070, Russia

Location

Local Institution

Korolyov, 141060, Russia

Location

Local Institution

Saint Petersburg, 194214, Russia

Location

Local Institution

Yaroslavl, 150003, Russia

Location

Local Institution - 0021

A Coruña, 15006, Spain

Location

Local Institution - 0022

Córdoba, 14004, Spain

Location

Local Institution - 0019

Madrid, 28046, Spain

Location

Local Institution - 0020

Sabadell, 08208, Spain

Location

Local Institution - 0123

Kaohsiung City, 833401, Taiwan

Location

Local Institution - 0121

Tainan, 704, Taiwan

Location

Local Institution - 0122

Tainan, 710, Taiwan

Location

Local Institution - 0120

Taipei, 110, Taiwan

Location

Local Institution - 0124

Taoyuan District, 333423, Taiwan

Location

Local Institution - 0106

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 0116

Harlow, CM227NR, United Kingdom

Location

Local Institution - 0107

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Arthritis, Psoriatic; Joint Diseases

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: May 28, 2021
• First Posted: June 1, 2021
• Study Start: July 13, 2021
• Primary Completion: September 5, 2024
• Study Completion (Estimated): June 10, 2027
• Last Updated: April 23, 2026
• Results First Posted: October 24, 2025

Record last verified: 2026-04

Data Sharing

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

Locations

BR (7); FI (3); IE (4); CZ (7); RO (14); GB (3); AU (6); ME (9); TW (5); PL (27); HU (8); AR (10); ES (4); US (33); CL (6); FR (3); CO (8); CN (8); RU (4); BU (10); IT (4)