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 or Had Previously Received TNFα Inhibitor Treatment

NCT04908189 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: IM011-0552020-005099-36U1111-1259-9466
• Study Type: interventional
• Target: 729
• Locations: 18 countries
• Sites: 138

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis; PsA; Deucravacitinib; BMS-986165; Apremilast; Otezla

Outcome Measures

Primary Outcomes (1)

• Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16

  The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

  Week 16

Secondary Outcomes (37)

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

  Baseline, Week 16

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

  Baseline, Week 16

• Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16

  Week 16

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

  Baseline, Week 16

• Number 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 (3)

Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Placebo

PLACEBO COMPARATOR

Drug: Deucravacitinib; Other: Placebo

Apremilast

OTHER

Drug: Apremilast

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165

Deucravacitinib; Placebo

Placebo OTHER

Specified dose on specified days

Placebo

Apremilast DRUG

Specified dose on specified days

Also known as: Otezla

Apremilast

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 (CASPAR) criteria 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
• 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 (138)

Local Institution - 0149

Mountain Brook, Alabama, 35223, United States

Location

Local Institution - 0212

Sacramento, California, 95815, United States

Location

Local Institution - 0188

Whittier, California, 90602, United States

Location

Local Institution - 0192

Skokie, Illinois, 60076, United States

Location

Local Institution - 0203

Hopkinsville, Kentucky, 42240, United States

Location

Local Institution - 0195

Baton Rouge, Louisiana, 70836, United States

Location

Local Institution - 0169

Cumberland, Maryland, 21502, United States

Location

Local Institution - 0034

Okemos, Michigan, 48864, United States

Location

Local Institution - 0133

Eagan, Minnesota, 55121, United States

Location

Local Institution - 0109

Hattiesburg, Mississippi, 39402, United States

Location

Local Institution - 0108

New York, New York, 10003, United States

Location

Local Institution - 0186

Rochester, New York, 14642, United States

Location

Local Institution - 0196

Charlotte, North Carolina, 28277, United States

Location

Local Institution - 0180

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0189

Oklahoma City, Oklahoma, 73116, United States

Location

Local Institution - 0147

Portland, Oregon, 97239, United States

Location

Local Institution - 0016

Duncansville, Pennsylvania, 16635, United States

Location

Local Institution - 0182

Summerville, South Carolina, 29486, United States

Location

Local Institution - 0167

Lubbock, Texas, 79424, United States

Location

Local Institution - 0070

Mesquite, Texas, 75150, United States

Location

Local Institution - 0184

Plano, Texas, 75024, United States

Location

Local Institution - 0187

Seattle, Washington, 98122, United States

Location

Local Institution - 0190

Franklin, Wisconsin, 53132, United States

Location

Local Institution - 0175

Milwaukee, Wisconsin, 53217, United States

Location

Local Institution - 0048

La Plata, Buenos Aires, 1900, Argentina

Location

Local Institution - 0038

San Isidro, Buenos Aires, 1642, Argentina

Location

Local Institution - 0039

CABA, Distrito Federal, C1015, Argentina

Location

Local Institution - 0171

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0200

Buenos Aires, 1426, Argentina

Location

Local Institution - 0003

Botany, New South Wales, 2019, Australia

Location

Local Institution - 0018

Paramatta, New South Wales, 2150, Australia

Location

Local Institution - 0004

Maroochydore, Queensland, 4558, Australia

Location

Local Institution - 0099

Woodville, South Australia, 5011, Australia

Location

Local Institution - 0002

Camberwell, Victoria, 3124, Australia

Location

Local Institution - 0017

Geelong, Victoria, 3220, Australia

Location

Local Institution - 0078

Brussels, 1200, Belgium

Location

Local Institution - 0058

Ghent, 9000, Belgium

Location

Local Institution - 0061

Liège, 4000, Belgium

Location

Local Institution - 0111

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Local Institution - 0006

Hamilton, Ontario, L8N 1Y2, Canada

Location

Local Institution - 0030

Markham, Ontario, L3P 1X3, Canada

Location

Local Institution - 0036

Toronto, Ontario, M5T 2S6, Canada

Location

Local Institution - 0001

Québec, G1V 3M7, Canada

Location

Local Institution - 0126

Bengbu, Anhui, 233004, China

Location

Local Institution - 0152

Beijing, Beijing Municipality, 100083, China

Location

Local Institution - 0146

Beijing, Beijing Municipality, 100730, China

Location

Local Institution - 0153

Guangzhou, Guangdong, 510180, China

Location

Local Institution - 0135

Guangzhou, Guangdong, 510317, China

Location

Local Institution - 0206

Shenzhen, Guangdong, 518020, China

Location

Local Institution - 0127

Zhengzhou, Henan, 450000, China

Location

Local Institution - 0170

Changsha, Hunan, 410008, China

Location

Local Institution - 0161

Changsha, Hunan, 410011, China

Location

Local Institution - 0125

Changzhou, Jiangsu, 213003, China

Location

Local Institution - 0138

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0139

Nantong, Jiangsu, 226001, China

Location

Local Institution - 0163

Wuxi, Jiangsu, 214023, China

Location

Local Institution - 0148

Jiujiang, Jiangxi, 332000, China

Location

Local Institution - 0131

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0156

Nanchang, Jiangxi, 330006, China

Location

Local Institution - 0140

Pingxiang, Jiangxi, 337055, China

Location

Local Institution - 0158

Baotou, Neimeng, 014010, China

Location

Local Institution - 0157

Hohhot, Neimeng, 010050, China

Location

Local Institution - 0154

Xi'an, Shan3xi, 710004, China

Location

Local Institution - 0207

Shanghai, Shanghai Municipality, 200052, China

Location

Local Institution - 0164

Chengdu, Sichuan, 610072, China

Location

Local Institution - 0117

Ürümqi, Xinjiang, 830001, China

Location

Local Institution - 0134

Kunming, Yunnan, 650032, China

Location

Local Institution - 0129

Wenzhou, Zhejiang, 32500, China

Location

Local Institution - 0072

Barranquilla, Atlántico, 080002, Colombia

Location

Local Institution - 0015

Bogotá, 110221, Colombia

Location

Local Institution - 0020

Cali, 760035, Colombia

Location

Local Institution - 0022

Chía, 250001, Colombia

Location

Local Institution - 0019

Medellín, 50036, Colombia

Location

Local Institution - 0010

Brno, 638 00, Czechia

Location

Local Institution - 0009

Ostrava, 702 00, Czechia

Location

Local Institution - 0035

Ostrava, 702 00, Czechia

Location

Local Institution - 0011

Prague, 12850, Czechia

Location

Local Institution - 0023

Uherské Hradiště, 686 01, Czechia

Location

Local Institution - 0176

Ratingen, North Rhine-Westphalia, 40878, Germany

Location

Local Institution - 0101

Cologne, 50937, Germany

Location

Local Institution - 0199

Erlangen, 91054, Germany

Location

Local Institution - 0046

Hamburg, 20095, Germany

Location

Local Institution - 0075

Magdeburg, 39120, Germany

Location

Local Institution - 0201

Minden, 32429, Germany

Location

Local Institution - 0074

Tübingen, 72076, Germany

Location

Local Institution - 0025

Veszprém, Veszprém City, 8200, Hungary

Location

Local Institution - 0197

Budapest, 1062, Hungary

Location

Local Institution - 0066

Debrecen, 4032, Hungary

Location

Local Institution - 0028

Gyula, 5700, Hungary

Location

Local Institution - 0024

Hódmezővásárhely, 6800, Hungary

Location

Local Institution - 0027

Kistarcsa, 2143, Hungary

Location

Azienda Ospedaliera Universitaria Careggi-Reumatologia

Florence, 50141, Italy

Location

AOR San Carlo di Potenza-UOC Reumatologia

Potenza, 85100, Italy

Location

Local Institution - 0097

Roma, 00168, Italy

Location

Local Institution - 0202

Nagoya, Aichi-ken, 457-8511, Japan

Location

Local Institution - 0106

Nagoya, Aichi-ken, 4678602, Japan

Location

Local Institution - 0151

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0179

Tsu, Mie-ken, 514-8507, Japan

Location

Local Institution - 0123

Kawachi-Nagano, Osaka, 586-8521, Japan

Location

Local Institution - 0205

Bunkyō, Tokyo, 113-8519, Japan

Location

Local Institution - 0121

Chuo-ku, Tokyo, 104-8560, Japan

Location

Local Institution - 0067

Itabashi-ku, Tokyo, 173-0003, Japan

Location

Local Institution - 0178

Meguro-ku, Tokyo, 1538515, Japan

Location

Local Institution - 0122

Minato-ku, Tokyo, 105-8471, Japan

Location

Local Institution - 0174

Mitaka, Tokyo, 181-8611, Japan

Location

Local Institution - 0065

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Local Institution - 0155

Fukuoka, 814-0180, Japan

Location

Local Institution - 0166

Osaka, 545-8585, Japan

Location

Local Institution - 0204

Osaka, 550-0006, Japan

Location

Local Institution - 0052

León, Guanajuato, 37160, Mexico

Location

Local Institution - 0051

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution - 0057

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0198

Mexico City, Mexico City, 14080, Mexico

Location

Local Institution - 0056

Mérida, Yucatán, 97000, Mexico

Location

Local Institution - 0053

Chihuahua City, 31203, Mexico

Location

Local Institution - 0082

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

Location

Local Institution - 0177

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Local Institution - 0079

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Local Institution - 0080

Elblag, 82-300, Poland

Location

Local Institution - 0081

Torun, 87-100, Poland

Location

Local Institution - 0112

Wroclaw, 50-088, Poland

Location

Local Institution

Moscow, 107045, Russia

Location

Local Institution

Novosibirsk, 630099, Russia

Location

Local Institution - 0014

Barcelona, 08035, Spain

Location

Local Institution - 0012

Madrid, 28041, Spain

Location

Local Institution - 0045

Santander, 39008, Spain

Location

Local Institution - 0013

Valencia, 46026, Spain

Location

Local Institution - 0090

Taichung, 402, Taiwan

Location

Local Institution - 0088

Taichung, 404332, Taiwan

Location

Local Institution - 0089

Taichung, 407, Taiwan

Location

Local Institution - 0091

Taipei, 10002, Taiwan

Location

Local Institution - 0087

Taipei, 11217, Taiwan

Location

Local Institution - 0185

London, England, SW17 0QT, United Kingdom

Location

Local Institution - 0060

Bradford, BD5 0NA, United Kingdom

Location

Local Institution - 0064

Hull, HU3 2JZ, United Kingdom

Location

Local Institution - 0077

Liverpool, L9 7AL, United Kingdom

Location

Local Institution - 0062

London, E11 1NR, United Kingdom

Location

Local Institution - 0105

Manchester, M13 9WL, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

deucravacitinib; apremilast

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; 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 15, 2021
• Primary Completion: February 6, 2024
• Study Completion (Estimated): November 12, 2026
• Last Updated: June 13, 2025
• Results First Posted: April 13, 2025

Record last verified: 2025-06

Locations

GB (6); US (24); CZ (5); AR (5); ES (4); CO (5); AU (6); RU (2); BE (3); CN (25); DE (7); CA (5); IT (3); HU (6); JP (15); PL (6); ME (6); TW (5)