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

Last updated: March 26, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Bone Diseases

Treatment

Deucravacitinib

Apremilast

Placebo

Clinical Study ID

NCT04908189
IM011-055
2020-005099-36
U1111-1259-9466
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration atScreening

  • Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria atScreening

  • Active plaque psoriatic skin lesion(s) or documented medical history of plaquepsoriasis (PsO) at Screening

  • Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screeningand 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-termextension period

Exclusion

Exclusion Criteria:

  • Nonplaque psoriasis at Screening or Day 1

  • Other autoimmune condition such as systemic lupus erythematous, mixed connectivetissue 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 orPsO

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 729
Treatment Group(s): 3
Primary Treatment: Deucravacitinib
Phase: 3
Study Start date:
July 15, 2021
Estimated Completion Date:
November 12, 2026

Connect with a study center

  • Local Institution

    C.a.b.a., Buenos Aires 1431
    Argentina

    Site Not Available

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Local Institution - 0048

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Local Institution - 0038

    San Isidro, Buenos Aires 1642
    Argentina

    Site Not Available

  • Local Institution - 0039

    Caba, Distrito Federal C1015
    Argentina

    Site Not Available

  • Local Institution - 0171

    San Miguel de Tucumán, Tucuman 4000
    Argentina

    Site Not Available

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, 1426
    Argentina

    Site Not Available

  • Local Institution - 0037

    Buenos Aires, 1431
    Argentina

    Site Not Available

  • Local Institution - 0200

    Buenos Aires, 1426
    Argentina

    Site Not Available

  • Local Institution

    Cordoba,
    Argentina

    Site Not Available

  • Local Institution - 0168

    Cordoba, 0
    Argentina

    Site Not Available

  • Emeritus Research

    Botany, New South Wales 2019
    Australia

    Active - Recruiting

  • Local Institution - 0003

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Local Institution

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • BJC Health

    Paramatta, New South Wales 2150
    Australia

    Site Not Available

  • Local Institution - 0018

    Paramatta, New South Wales 2150
    Australia

    Site Not Available

  • BJC Health

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Local Institution - 0004

    Maroochydore, Queensland 4558
    Australia

    Site Not Available

  • Local Institution - 0099

    Woodville, South Australia 5011
    Australia

    Site Not Available

  • Local Institution

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • Emeritus Research

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Local Institution - 0002

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Local Institution - 0017

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Local Institution

    Brussel, 1200
    Belgium

    Site Not Available

  • Local Institution - 0078

    Brussels, 1200
    Belgium

    Site Not Available

  • Local Institution - 0058

    Gent, 9000
    Belgium

    Site Not Available

  • Local Institution

    Leuven, 3000
    Belgium

    Site Not Available

  • Local Institution - 0104

    Leuven, 3000
    Belgium

    Site Not Available

  • Local Institution - 0061

    Liège, 4000
    Belgium

    Site Not Available

  • Local Institution - 0111

    Vancouver, British Columbia V5Z 4E8
    Canada

    Site Not Available

  • Local Institution - 0006

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Local Institution - 0030

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Local Institution

    Toronto, Ontario M5T 2S6
    Canada

    Site Not Available

  • Local Institution - 0036

    Toronto, Ontario M5T 2S6
    Canada

    Site Not Available

  • Local Institution

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Local Institution - 0001

    Quebec, G1V 3M7
    Canada

    Site Not Available

  • Local Institution - 0126

    Bengbu, Anhui 233004
    China

    Site Not Available

  • Local Institution - 0146

    Beijing, Beijing 100730
    China

    Site Not Available

  • Local Institution - 0152

    Beijing, Beijing 100083
    China

    Site Not Available

  • Local Institution - 0135

    Guangzhou, Guangdong 510317
    China

    Site Not Available

  • Local Institution - 0153

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Local Institution - 0206

    Shenzhen, Guangdong 518020
    China

    Site Not Available

  • Local Institution - 0127

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Local Institution

    Changsha, Hunan 410021
    China

    Active - Recruiting

  • Local Institution - 0161

    Changsha, Hunan 410011
    China

    Site Not Available

  • Local Institution - 0170

    Changsha, Hunan 410008
    China

    Site Not Available

  • Local Institution - 0125

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Local Institution - 0138

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Local Institution - 0139

    Nantong, Jiangsu 226001
    China

    Site Not Available

  • Local Institution - 0163

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Local Institution - 0148

    Jiujiang, Jiangxi 332000
    China

    Site Not Available

  • Local Institution - 0131

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Local Institution - 0156

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Local Institution - 0140

    Pingxiang, Jiangxi 337055
    China

    Site Not Available

  • Local Institution - 0191

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Local Institution - 0158

    Baotou, Neimeng 014010
    China

    Site Not Available

  • Local Institution - 0157

    Hohhot, Neimeng 010050
    China

    Site Not Available

  • Local Institution - 0154

    Xi'An, Shan3xi 710004
    China

    Site Not Available

  • Local Institution - 0207

    Shanghai, Shanghai 200052
    China

    Site Not Available

  • Local Institution - 0164

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • Local Institution - 0117

    Urumqi, Xinjiang 830001
    China

    Site Not Available

  • Local Institution - 0134

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Local Institution - 0129

    Wenzhou, Zhejiang 32500
    China

    Site Not Available

  • Local Institution - 0072

    Barranquilla, Atlántico 080002
    Colombia

    Site Not Available

  • Local Institution - 0015

    Bogotá, 110221
    Colombia

    Site Not Available

  • Local Institution - 0020

    Cali, 760035
    Colombia

    Site Not Available

  • Local Institution

    Chapinero, 110221042
    Colombia

    Site Not Available

  • Local Institution

    Chia, 250001
    Colombia

    Site Not Available

  • Local Institution - 0022

    Chía, 250001
    Colombia

    Site Not Available

  • Local Institution - 0019

    Medellin, 50036
    Colombia

    Site Not Available

  • Local Institution - 0010

    Brno, 638 00
    Czechia

    Site Not Available

  • Local Institution

    Hostivice, 253 01
    Czechia

    Site Not Available

  • Local Institution - 0009

    Ostrava, 702 00
    Czechia

    Site Not Available

  • Local Institution - 0035

    Ostrava, 702 00
    Czechia

    Site Not Available

  • Revmatologicky ustav

    Praha, 12500
    Czechia

    Site Not Available

  • Local Institution - 0011

    Praha 2, 12850
    Czechia

    Site Not Available

  • Local Institution - 0023

    Uherske Hradiste, 686 01
    Czechia

    Site Not Available

  • Local Institution - 0176

    Ratingen, Nordrhein-Westfalen 40878
    Germany

    Site Not Available

  • Local Institution

    Bonn, 53127
    Germany

    Site Not Available

  • Local Institution

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Local Institution - 0100

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Local Institution - 0199

    Erlangen, 91054
    Germany

    Site Not Available

  • Local Institution

    Gera, 07548
    Germany

    Site Not Available

  • Local Institution

    Hamburg, 22391
    Germany

    Site Not Available

  • Local Institution - 0046

    Hamburg, 20095
    Germany

    Site Not Available

  • Local Institution - 0101

    Köln, 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln-Medizinische Klinik I fuer Innere Medizin

    Köln, 50937
    Germany

    Active - Recruiting

  • Local Institution - 0075

    Magdeburg, 39120
    Germany

    Site Not Available

  • Local Institution - 0201

    Minden, 32429
    Germany

    Site Not Available

  • Uniklinik Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Local Institution - 0074

    Tübingen, 72076
    Germany

    Site Not Available

  • Local Institution - 0025

    Veszprem, Veszprém City 8200
    Hungary

    Site Not Available

  • Local Institution - 0197

    Budapest, 1062
    Hungary

    Site Not Available

  • Local Institution - 0066

    Debrecen, 4032
    Hungary

    Site Not Available

  • Local Institution - 0028

    Gyula, 5700
    Hungary

    Site Not Available

  • Local Institution - 0024

    Hódmezővásárhely, 6800
    Hungary

    Site Not Available

  • Local Institution - 0027

    Kistarcsa, 2143
    Hungary

    Site Not Available

  • Local Institution - 0024

    Szarvas, 6600
    Hungary

    Site Not Available

  • Local Institution

    Szentes, 6600
    Hungary

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi-Reumatologia

    Firenze, 50141
    Italy

    Site Not Available

  • AOR San Carlo di Potenza-UOC Reumatologia

    Potenza, 85100
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli-UOC Reumatologia

    Roma, 00168
    Italy

    Site Not Available

  • Local Institution - 0097

    Roma, 00168
    Italy

    Site Not Available

  • Local Institution

    Rome, 00168
    Italy

    Site Not Available

  • Local Institution - 0202

    Nagoya, Aichi 457-8511
    Japan

    Site Not Available

  • Local Institution - 0106

    Nagoya-shi, Aichi 4678602
    Japan

    Site Not Available

  • Local Institution - 0155

    Fukuoka, Jonan-Ku, Fukuoka 814-0180
    Japan

    Site Not Available

  • Local Institution - 0151

    Sapporo, Hokkaido 0608648
    Japan

    Site Not Available

  • Local Institution - 0179

    Tsu, MIE 514-8507
    Japan

    Site Not Available

  • Local Institution - 0123

    Kawachinagano, Osaka 586-8521
    Japan

    Site Not Available

  • Local Institution - 0205

    Bunkyō, Tokyo 113-8519
    Japan

    Site Not Available

  • Local Institution - 0121

    Chuo-ku, Tokyo 104-8560
    Japan

    Site Not Available

  • Local Institution - 0067

    Itabashi-ku, Tokyo 173-0003
    Japan

    Site Not Available

  • Local Institution - 0178

    Meguro-ku, Tokyo 1538515
    Japan

    Site Not Available

  • Local Institution

    Minato-ku, Tokyo 105-8471
    Japan

    Active - Recruiting

  • Local Institution - 0122

    Minato-ku, Tokyo 105-8471
    Japan

    Site Not Available

  • Local Institution

    Mitaka, Tokyo 181-8611
    Japan

    Active - Recruiting

  • Local Institution - 0174

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • Local Institution - 0065

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Site Not Available

  • Local Institution

    Fukuoka, 8140180
    Japan

    Site Not Available

  • Local Institution - 0155

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • Local Institution - 0166

    Osaka, 545-8585
    Japan

    Site Not Available

  • Local Institution - 0204

    Osaka, 550-0006
    Japan

    Site Not Available

  • Local Institution - 0198

    Mexico City, Distrito Federal 14080
    Mexico

    Site Not Available

  • Local Institution - 0052

    Leon, Guanajuato 37160
    Mexico

    Site Not Available

  • Local Institution

    León, Guanajuato 37160
    Mexico

    Site Not Available

  • Local Institution - 0051

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Local Institution - 0057

    Zapopan, Jalisco 45070
    Mexico

    Site Not Available

  • Local Institution - 0056

    Merida, Yucatan 97000
    Mexico

    Site Not Available

  • Local Institution - 0053

    Chihuahua, 31203
    Mexico

    Site Not Available

  • Local Institution - 0082

    Bydgoszcz, Kujawsko-pomorskie 85-168
    Poland

    Site Not Available

  • Local Institution - 0177

    Warszawa, Mazowieckie 02-665
    Poland

    Site Not Available

  • Local Institution - 0079

    Gdansk, Pomorskie 80-546
    Poland

    Site Not Available

  • Local Institution - 0080

    Elblag, 82-300
    Poland

    Site Not Available

  • Local Institution - 0081

    Torun, 87-100
    Poland

    Site Not Available

  • Local Institution

    Wroclaw, 50-088
    Poland

    Site Not Available

  • Local Institution

    Wroc£aw, 50-088
    Poland

    Site Not Available

  • Local Institution - 0112

    Wrocław, 50-088
    Poland

    Site Not Available

  • Local Institution - 0208

    Saint Petersburg, Sankt-Peterburg 197022
    Russian Federation

    Site Not Available

  • Local Institution

    Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • Local Institution

    Kazan, 420097
    Russian Federation

    Site Not Available

  • Local Institution

    Moscow, 107045
    Russian Federation

    Site Not Available

  • Local Institution

    Novosibirsk, 630099
    Russian Federation

    Site Not Available

  • Local Institution

    Saint Petersburg, 194214
    Russian Federation

    Site Not Available

  • Local Institution - 0145

    Saint Petersburg, 190068
    Russian Federation

    Site Not Available

  • Local Institution

    Saint-Petersburg, 197022
    Russian Federation

    Site Not Available

  • Local Institution

    Vladimir, 600023
    Russian Federation

    Site Not Available

  • Local Institution - 0014

    Barcelona, 08035
    Spain

    Site Not Available

  • Local Institution - 0012

    Madrid, 28041
    Spain

    Site Not Available

  • Local Institution - 0045

    Santander, 39008
    Spain

    Site Not Available

  • Local Institution

    Valencia, 46026
    Spain

    Site Not Available

  • Local Institution - 0013

    València, 46026
    Spain

    Site Not Available

  • Local Institution - 0088

    Taichung, 404332
    Taiwan

    Site Not Available

  • Local Institution - 0089

    Taichung, 407
    Taiwan

    Site Not Available

  • Local Institution - 0090

    Taichung City, 402
    Taiwan

    Site Not Available

  • Local Institution - 0087

    Taipei, 11217
    Taiwan

    Site Not Available

  • Local Institution - 0091

    Taipei, 10002
    Taiwan

    Site Not Available

  • Local Institution - 0185

    London, England SW17 0QT
    United Kingdom

    Site Not Available

  • Local Institution - 0060

    Bradford, BD5 0NA
    United Kingdom

    Site Not Available

  • Local Institution - 0064

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Local Institution - 0077

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Local Institution - 0062

    London, E11 1NR
    United Kingdom

    Site Not Available

  • Local Institution - 0105

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Rheumatology Associates, Pc

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Local Institution - 0149

    Mountain Brook, Alabama 35223
    United States

    Site Not Available

  • Rheumatology Associates

    Mountain Brook, Alabama 35223
    United States

    Active - Recruiting

  • First OC Dermatology-Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Local Institution

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Integrative Skin Science and Research - Location 2

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Local Institution - 0212

    Sacramento, California 95815
    United States

    Site Not Available

  • Local Institution - 0188

    Whittier, California 90602
    United States

    Site Not Available

  • Medvin Clinical Research - Su

    Whittier, California 90602
    United States

    Active - Recruiting

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Local Institution - 0192

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Local Institution - 0203

    Hopkinsville, Kentucky 42240
    United States

    Site Not Available

  • Western KY Rheumatology

    Hopkinsville, Kentucky 42240
    United States

    Active - Recruiting

  • Local Institution - 0195

    Baton Rouge, Louisiana 70836
    United States

    Site Not Available

  • Ochsner Medical Complex - The Grove

    Baton Rouge, Louisiana 70836
    United States

    Active - Recruiting

  • Klein And Associates, M.D., Pa

    Cumberland, Maryland 21502
    United States

    Active - Recruiting

  • Local Institution - 0169

    Cumberland, Maryland 21502
    United States

    Site Not Available

  • Advanced Rheumatology, PC

    Lansing, Michigan 48910
    United States

    Active - Recruiting

  • Local Institution - 0034

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Local Institution - 0034

    Okemos, Michigan 48864
    United States

    Site Not Available

  • Local Institution - 0133

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • Saint Paul Rheumatology

    Eagan, Minnesota 55121
    United States

    Active - Recruiting

  • Arthritis Associates

    Hattiesburg, Mississippi 39402
    United States

    Active - Recruiting

  • Local Institution - 0109

    Hattiesburg, Mississippi 39402
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai-Department of Dermatology

    New York, New York 10003
    United States

    Active - Recruiting

  • Local Institution - 0108

    New York, New York 10003
    United States

    Site Not Available

  • Local Institution - 0186

    Rochester, New York 14642
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Local Institution - 0196

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • OnSite Clinical Solutions

    Charlotte, North Carolina 28277
    United States

    Active - Recruiting

  • Local Institution - 0180

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center-Medicine

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Local Institution - 0189

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • RAO Research LLC

    Oklahoma City, Oklahoma 73116
    United States

    Active - Recruiting

  • Local Institution - 0147

    Portland, Oregon 97239
    United States

    Site Not Available

  • OHSU Center for Hematologic Malignancies

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Local Institution - 0016

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Local Institution - 0182

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Low Country Rheumatology

    Summerville, South Carolina 29486
    United States

    Active - Recruiting

  • Local Institution - 0167

    Lubbock, Texas 79424
    United States

    Site Not Available

  • West Texas Clinical Research

    Lubbock, Texas 79424
    United States

    Active - Recruiting

  • Local Institution - 0070

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Southwest Rheumatology Research

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Local Institution - 0184

    Plano, Texas 75024
    United States

    Site Not Available

  • Trinity Universal Research Associates

    Plano, Texas 75024
    United States

    Active - Recruiting

  • Local Institution - 0187

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Active - Recruiting

  • University Of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Aurora Rheumatology

    Franklin, Wisconsin 53132
    United States

    Active - Recruiting

  • Local Institution - 0190

    Franklin, Wisconsin 53132
    United States

    Site Not Available

  • Local Institution

    Glendale, Wisconsin 53217
    United States

    Site Not Available

  • Local Institution - 0175

    Milwaukee, Wisconsin 53217
    United States

    Site Not Available

  • Rheumatic Disease Center

    Milwaukee, Wisconsin 53217
    United States

    Active - Recruiting

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