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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
Sponsor: Bristol-Myers Squibb
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.
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
729
Start Date
2021-07-15
Completion Date
2026-11-12
Last Updated
2025-06-13
Healthy Volunteers
No
Conditions
Interventions
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Apremilast
Specified dose on specified days
Locations (138)
Local Institution - 0149
Mountain Brook, Alabama, United States
Local Institution - 0212
Sacramento, California, United States
Local Institution - 0188
Whittier, California, United States
Local Institution - 0192
Skokie, Illinois, United States
Local Institution - 0203
Hopkinsville, Kentucky, United States
Local Institution - 0195
Baton Rouge, Louisiana, United States
Local Institution - 0169
Cumberland, Maryland, United States
Local Institution - 0034
Okemos, Michigan, United States
Local Institution - 0133
Eagan, Minnesota, United States
Local Institution - 0109
Hattiesburg, Mississippi, United States
Local Institution - 0108
New York, New York, United States
Local Institution - 0186
Rochester, New York, United States
Local Institution - 0196
Charlotte, North Carolina, United States
Local Institution - 0180
Cleveland, Ohio, United States
Local Institution - 0189
Oklahoma City, Oklahoma, United States
Local Institution - 0147
Portland, Oregon, United States
Local Institution - 0016
Duncansville, Pennsylvania, United States
Local Institution - 0182
Summerville, South Carolina, United States
Local Institution - 0167
Lubbock, Texas, United States
Local Institution - 0070
Mesquite, Texas, United States
Local Institution - 0184
Plano, Texas, United States
Local Institution - 0187
Seattle, Washington, United States
Local Institution - 0190
Franklin, Wisconsin, United States
Local Institution - 0175
Milwaukee, Wisconsin, United States
Local Institution - 0048
La Plata, Buenos Aires, Argentina
Local Institution - 0038
San Isidro, Buenos Aires, Argentina
Local Institution - 0039
CABA, Distrito Federal, Argentina
Local Institution - 0171
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0200
Buenos Aires, Argentina
Local Institution - 0003
Botany, New South Wales, Australia
Local Institution - 0018
Paramatta, New South Wales, Australia
Local Institution - 0004
Maroochydore, Queensland, Australia
Local Institution - 0099
Woodville, South Australia, Australia
Local Institution - 0002
Camberwell, Victoria, Australia
Local Institution - 0017
Geelong, Victoria, Australia
Local Institution - 0078
Brussels, Belgium
Local Institution - 0058
Ghent, Belgium
Local Institution - 0061
Liège, Belgium
Local Institution - 0111
Vancouver, British Columbia, Canada
Local Institution - 0006
Hamilton, Ontario, Canada
Local Institution - 0030
Markham, Ontario, Canada
Local Institution - 0036
Toronto, Ontario, Canada
Local Institution - 0001
Québec, Canada
Local Institution - 0126
Bengbu, Anhui, China
Local Institution - 0152
Beijing, Beijing Municipality, China
Local Institution - 0146
Beijing, Beijing Municipality, China
Local Institution - 0153
Guangzhou, Guangdong, China
Local Institution - 0135
Guangzhou, Guangdong, China
Local Institution - 0206
Shenzhen, Guangdong, China
Local Institution - 0127
Zhengzhou, Henan, China
Local Institution - 0170
Changsha, Hunan, China
Local Institution - 0161
Changsha, Hunan, China
Local Institution - 0125
Changzhou, Jiangsu, China
Local Institution - 0138
Nanjing, Jiangsu, China
Local Institution - 0139
Nantong, Jiangsu, China
Local Institution - 0163
Wuxi, Jiangsu, China
Local Institution - 0148
Jiujiang, Jiangxi, China
Local Institution - 0131
Nanchang, Jiangxi, China
Local Institution - 0156
Nanchang, Jiangxi, China
Local Institution - 0140
Pingxiang, Jiangxi, China
Local Institution - 0158
Baotou, Neimeng, China
Local Institution - 0157
Hohhot, Neimeng, China
Local Institution - 0154
Xi'an, Shan3xi, China
Local Institution - 0207
Shanghai, Shanghai Municipality, China
Local Institution - 0164
Chengdu, Sichuan, China
Local Institution - 0117
Ürümqi, Xinjiang, China
Local Institution - 0134
Kunming, Yunnan, China
Local Institution - 0129
Wenzhou, Zhejiang, China
Local Institution - 0072
Barranquilla, Atlántico, Colombia
Local Institution - 0015
Bogotá, Colombia
Local Institution - 0020
Cali, Colombia
Local Institution - 0022
Chía, Colombia
Local Institution - 0019
Medellín, Colombia
Local Institution - 0010
Brno, Czechia
Local Institution - 0009
Ostrava, Czechia
Local Institution - 0035
Ostrava, Czechia
Local Institution - 0011
Prague, Czechia
Local Institution - 0023
Uherské Hradiště, Czechia
Local Institution - 0176
Ratingen, North Rhine-Westphalia, Germany
Local Institution - 0101
Cologne, Germany
Local Institution - 0199
Erlangen, Germany
Local Institution - 0046
Hamburg, Germany
Local Institution - 0075
Magdeburg, Germany
Local Institution - 0201
Minden, Germany
Local Institution - 0074
Tübingen, Germany
Local Institution - 0025
Veszprém, Veszprém City, Hungary
Local Institution - 0197
Budapest, Hungary
Local Institution - 0066
Debrecen, Hungary
Local Institution - 0028
Gyula, Hungary
Local Institution - 0024
Hódmezővásárhely, Hungary
Local Institution - 0027
Kistarcsa, Hungary
Azienda Ospedaliera Universitaria Careggi-Reumatologia
Florence, Italy
AOR San Carlo di Potenza-UOC Reumatologia
Potenza, Italy
Local Institution - 0097
Roma, Italy
Local Institution - 0202
Nagoya, Aichi-ken, Japan
Local Institution - 0106
Nagoya, Aichi-ken, Japan
Local Institution - 0151
Sapporo, Hokkaido, Japan
Local Institution - 0179
Tsu, Mie-ken, Japan
Local Institution - 0123
Kawachi-Nagano, Osaka, Japan
Local Institution - 0205
Bunkyō, Tokyo, Japan
Local Institution - 0121
Chuo-ku, Tokyo, Japan
Local Institution - 0067
Itabashi-ku, Tokyo, Japan
Local Institution - 0178
Meguro-ku, Tokyo, Japan
Local Institution - 0122
Minato-ku, Tokyo, Japan
Local Institution - 0174
Mitaka, Tokyo, Japan
Local Institution - 0065
Shinjuku-ku, Tokyo, Japan
Local Institution - 0155
Fukuoka, Japan
Local Institution - 0166
Osaka, Japan
Local Institution - 0204
Osaka, Japan
Local Institution - 0052
León, Guanajuato, Mexico
Local Institution - 0051
Guadalajara, Jalisco, Mexico
Local Institution - 0057
Zapopan, Jalisco, Mexico
Local Institution - 0198
Mexico City, Mexico City, Mexico
Local Institution - 0056
Mérida, Yucatán, Mexico
Local Institution - 0053
Chihuahua City, Mexico
Local Institution - 0082
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0177
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0079
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0080
Elblag, Poland
Local Institution - 0081
Torun, Poland
Local Institution - 0112
Wroclaw, Poland
Local Institution
Moscow, Russia
Local Institution
Novosibirsk, Russia
Local Institution - 0014
Barcelona, Spain
Local Institution - 0012
Madrid, Spain
Local Institution - 0045
Santander, Spain
Local Institution - 0013
Valencia, Spain
Local Institution - 0090
Taichung, Taiwan
Local Institution - 0088
Taichung, Taiwan
Local Institution - 0089
Taichung, Taiwan
Local Institution - 0091
Taipei, Taiwan
Local Institution - 0087
Taipei, Taiwan
Local Institution - 0185
London, England, United Kingdom
Local Institution - 0060
Bradford, United Kingdom
Local Institution - 0064
Hull, United Kingdom
Local Institution - 0077
Liverpool, United Kingdom
Local Institution - 0062
London, United Kingdom
Local Institution - 0105
Manchester, United Kingdom