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
NCT ID: NCT04908202
Last Updated: 2025-10-24
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
670 participants
INTERVENTIONAL
2021-07-13
2027-06-10
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
Placebo
Specified dose on specified days
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
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 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.
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 - 0197
Gilbert, Arizona, United States
Local Institution - 0188
Jonesboro, Arkansas, United States
Local Institution - 0168
Fontana, California, United States
Local Institution - 0199
Fullerton, California, United States
Local Institution - 0038
Sacramento, California, United States
Cohen Medical Centers
Thousand Oaks, California, United States
Local Institution - 0170
Denver, Colorado, United States
Local Institution - 0195
Clearwater, Florida, United States
Local Institution - 0272
Margate, Florida, United States
Local Institution - 0082
Miami Lakes, Florida, United States
Local Institution - 0171
Gainesville, Georgia, United States
Local Institution - 0087
Boise, Idaho, United States
Local Institution - 0080
Chicago, Illinois, United States
Local Institution - 0177
Orland Park, Illinois, United States
Local Institution - 0178
Schaumburg, Illinois, United States
Local Institution - 0083
Lexington, Kentucky, United States
Local Institution - 0042
Hagerstown, Maryland, United States
Local Institution - 0198
Detroit, Michigan, United States
Local Institution - 0201
Springfield, Missouri, United States
Local Institution - 0268
Kalispell, Montana, United States
Local Institution - 0186
Voorhees Township, New Jersey, United States
University Hospitals Cleveland Medical Center-Dermatology
Cleveland, Ohio, United States
Local Institution - 0028
Middleburg Heights, Ohio, United States
Local Institution - 0179
Perrysburg, Ohio, United States
Local Institution - 0182
Oklahoma City, Oklahoma, United States
Local Institution - 0185
Corvallis, Oregon, United States
Local Institution - 0175
Greenville, South Carolina, United States
Local Institution - 0036
Jackson, Tennessee, United States
Local Institution - 0172
Allen, Texas, United States
Local Institution - 0189
Amarillo, Texas, United States
Local Institution - 0032
Dallas, Texas, United States
Local Institution - 0273
Bothell, Washington, United States
Local Institution - 0181
Beckley, West Virginia, United States
Local Institution - 0213
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0054
La Plata, Buenos Aires, Argentina
Local Institution - 0215
Quilmes, Buenos Aires, Argentina
Local Institution - 0046
Córdoba, Córdoba Province, Argentina
Local Institution - 0196
Rosario, Santa Fe Province, Argentina
Local Institution - 0047
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0194
Buenos Aires, , Argentina
Local Institution - 0169
Buenos Aires, , Argentina
Local Institution - 0192
Buenos Aires, , Argentina
Local Institution - 0193
Mendoza, , Argentina
Local Institution - 0220
Phillip, Australian Capital Territory, Australia
Local Institution - 0137
Botany, New South Wales, Australia
Local Institution - 0133
Westmead, New South Wales, Australia
Local Institution - 0132
Woolloongabba, Queensland, Australia
Local Institution - 0211
Hobart, Tasmania, Australia
Local Institution - 0136
Camberwell, Victoria, Australia
Local Institution - 0109
Vitória, Espírito Santo, Brazil
Local Institution - 0001
Salvador, Estado de Bahia, Brazil
Local Institution - 0002
Juiz de Fora, Minas Gerais, Brazil
Local Institution - 0219
Curitiba, Paraná, Brazil
Local Institution - 0214
Curitiba, Paraná, Brazil
Local Institution - 0005
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0108
Santo André, São Paulo, Brazil
Local Institution - 0255
Plovdiv, Plovdiv, Bulgaria
Local Institution - 0248
Sofia, Sofia (stolitsa), Bulgaria
Local Institution - 0253
Burgas, , Bulgaria
Local Institution - 0249
Plovdiv, , Bulgaria
Local Institution - 0267
Plovdiv, , Bulgaria
Local Institution - 0246
Plovdiv, , Bulgaria
Local Institution - 0247
Plovdiv, , Bulgaria
Local Institution - 0245
Sofia, , Bulgaria
Local Institution - 0259
Sofia, , Bulgaria
Local Institution - 0250
Varna, , Bulgaria
Local Institution - 0261
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0226
Santiago, Santiago Metropolitan, Chile
Local Institution - 0099
Santiago, Santiago Metropolitan, Chile
Local Institution - 0073
Santiago, Santiago Metropolitan, Chile
Local Institution - 0222
Santiago, Santiago Metropolitan, Chile
Local Institution - 0111
Santiago, Santiago Metropolitan, Chile
Local Institution - 0149
Hefei, Anhui, China
Local Institution - 0159
Beijing, Beijing Municipality, China
Local Institution - 0190
Chongqing, Chongqing Municipality, China
Local Institution - 0147
Guangzhou, Guangdong, China
Local Institution - 0143
Shenzhen, Guangdong, China
Local Institution - 0150
Dalian, Liaoning, China
Local Institution - 0146
Shanghai, Shanghai Municipality, China
Local Institution - 0145
Yiwu, Zhejiang, China
Local Institution - 0071
Bucaramanga, Santander Department, Colombia
Local Institution - 0072
Barranquilla, , Colombia
Local Institution - 0069
Bogotá, , Colombia
Local Institution - 0063
Bogotá, , Colombia
Local Institution - 0070
Cali, , Colombia
Local Institution - 0094
Medellín, , Colombia
Local Institution - 0064
Medellín, , Colombia
Local Institution - 0065
Zipaquirá, , Colombia
Local Institution - 0225
Prague, Praha 5, Czechia
Local Institution - 0269
Uherské Hradiště, Zlín, Czechia
Local Institution - 0202
Zlín, Zlín, Czechia
Local Institution - 0018
Ostrava, , Czechia
Local Institution - 0208
Pardubice, , Czechia
Local Institution - 0097
Prague, , Czechia
Local Institution - 0017
Prague, , Czechia
Local Institution - 0089
Kuopio, Northern Savonia, Finland
Local Institution - 0013
Helsinki, , Finland
Local Institution - 0119
Turku, , Finland
Local Institution - 0077
Chambray-lès-Tours, , France
Local Institution - 0075
Montpellier, , France
Local Institution - 0074
Paris, , France
Local Institution - 0270
Gyula, Bekes County, Hungary
Local Institution - 0049
Székesfehérvár, Fejér, Hungary
Local Institution - 0023
Budapest, , Hungary
Local Institution - 0142
Budapest, , Hungary
Local Institution - 0026
Budapest, , Hungary
Local Institution - 0025
Budapest, , Hungary
Local Institution - 0203
Budapest, , Hungary
Local Institution - 0068
Zalaegerszeg, , Hungary
Local Institution - 0104
Manorhamilton, Leitrim, Ireland
Local Institution - 0101
Dublin, , Ireland
Local Institution - 0102
Dublin, , Ireland
Local Institution - 0103
Galway, , Ireland
Local Institution - 0066
Genova, , Italy
Local Institution - 0062
Pavia, , Italy
Local Institution - 0096
Udine, , Italy
Local Institution - 0058
Verona, , Italy
Local Institution - 0056
Saltillo, Coahuila, Mexico
Local Institution - 0254
Guadalajara, Jalisco, Mexico
Local Institution - 0057
Mexico City, Mexico City, Mexico
Local Institution - 0128
San Luis Potosí City, San Luis Potosí, Mexico
Local Institution - 0061
Mérida, Yucatán, Mexico
Local Institution - 0212
Mérida, Yucatán, Mexico
Local Institution - 0060
Chihuahua City, , Mexico
Local Institution - 0209
Mexico City, , Mexico
Local Institution - 0095
Veracruz, , Mexico
Local Institution - 0231
Dąbrówka, Greater Poland Voivodeship, Poland
Local Institution - 0229
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0206
Nowy Targ, Lesser Poland Voivodeship, Poland
Local Institution - 0244
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0232
Lublin, Lublin Voivodeship, Poland
Local Institution - 0230
Świdnik, Lublin Voivodeship, Poland
Local Institution - 0233
Nadarzyn, Masovian Voivodeship, Poland
Local Institution - 0235
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0243
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0236
Wołomin, Masovian Voivodeship, Poland
Local Institution - 0257
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0234
Gdynia, Pomeranian Voivodeship, Poland
Local Institution - 0241
Częstochowa, Silesian Voivodeship, Poland
Local Institution - 0252
Katowice, Silesian Voivodeship, Poland
Local Institution - 0114
Bialystok, , Poland
Local Institution - 0126
Krakow, , Poland
Local Institution - 0127
Krakow, , Poland
Local Institution - 0140
Krakow, , Poland
Local Institution - 0162
Olsztyn, , Poland
Local Institution - 0113
Poznan, , Poland
Local Institution - 0239
Poznan, , Poland
Local Institution - 0112
Poznan, , Poland
Local Institution - 0204
Warsaw, , Poland
Local Institution - 0205
Warsaw, , Poland
Local Institution - 0125
Warsaw, , Poland
Local Institution - 0210
Wroclaw, , Poland
Local Institution - 0238
Lodz, Łódź Voivodeship, Poland
Local Institution - 0090
Bucharest, București, Romania
Local Institution - 0266
Bucharest, București, Romania
Local Institution - 0010
Râmnicu Vâlcea, Vâlcea County, Romania
Local Institution - 0012
Brasov, , Romania
Local Institution - 0167
Bucharest, , Romania
Local Institution - 0260
Bucharest, , Romania
Local Institution - 0263
Bucharest, , Romania
Local Institution - 0184
Bucharest, , Romania
Local Institution - 0011
Cluj-Napoca, , Romania
Local Institution - 0258
Craiova, , Romania
Local Institution - 0262
Iași, , Romania
Local Institution - 0265
Iași, , Romania
Local Institution - 0264
Iași, , Romania
Local Institution - 0091
Timișoara, , Romania
Local Institution
Kemerovo, , Russia
Local Institution
Korolyov, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Yaroslavl, , Russia
Local Institution - 0021
A Coruña, , Spain
Local Institution - 0022
Córdoba, , Spain
Local Institution - 0019
Madrid, , Spain
Local Institution - 0020
Sabadell, , Spain
Local Institution - 0123
Kaohsiung City, , Taiwan
Local Institution - 0121
Tainan City, , Taiwan
Local Institution - 0122
Tainan City, , Taiwan
Local Institution - 0120
Taipei, , Taiwan
Local Institution - 0124
Taoyuan District, , Taiwan
Local Institution - 0106
Southampton, Hampshire, United Kingdom
Local Institution - 0116
Harlow, , United Kingdom
Local Institution - 0107
Stoke-on-Trent, , 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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2023-506256-25
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1259-9443
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM011-054
Identifier Type: -
Identifier Source: org_study_id
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