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
NCT ID: NCT04908189
Last Updated: 2025-06-13
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
729 participants
INTERVENTIONAL
2021-07-15
2026-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Deucravacitinib
Deucravacitinib
Specified dose on specified days
Placebo
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Apremilast
Apremilast
Specified dose on specified days
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Apremilast
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-005099-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1259-9466
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM011-055
Identifier Type: -
Identifier Source: org_study_id
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