Psoriasis Clinical Trial

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

Summary

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
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

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.
Other protocol-defined Inclusion/Exclusion criteria apply.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT04908202

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 180 Locations for this study

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Local Institution - 0197
Gilbert Arizona, 85297, United States
Local Institution - 0188
Jonesboro Arkansas, 72401, United States
Local Institution - 0168
Fontana California, 92335, United States
Local Institution
Fountain Valley California, 92708, United States
Local Institution - 0199
Fullerton California, 92835, United States
Local Institution
Palm Desert California, 92260, United States
Local Institution - 0038
Sacramento California, 95815, United States
Cohen Medical Centers
Thousand Oaks California, 91360, United States
Local Institution - 0170
Denver Colorado, 80230, United States
Local Institution - 0195
Clearwater Florida, 33765, United States
Local Institution - 0272
Margate Florida, 33063, United States
Local Institution - 0082
Miami Lakes Florida, 33014, United States
Local Institution - 0171
Gainesville Georgia, 30501, United States
Local Institution - 0087
Boise Idaho, 83702, United States
Local Institution - 0080
Chicago Illinois, 60640, United States
Local Institution - 0177
Orland Park Illinois, 60467, United States
Local Institution - 0178
Schaumburg Illinois, 60195, United States
Arthritis Center of Lexington-Bluegrass Community Research, Inc.
Lexington Kentucky, 40504, United States
Local Institution - 0042
Hagerstown Maryland, 21740, United States
Local Institution - 0198
Detroit Michigan, 48202, United States
Local Institution - 0201
Springfield Missouri, 65807, United States
Local Institution - 0268
Kalispell Montana, 59901, United States
Local Institution
Toms River New Jersey, 08755, United States
Local Institution - 0186
Voorhees New Jersey, 08043, United States
University Hospitals Cleveland Medical Center-Dermatology
Cleveland Ohio, 44106, United States
Local Institution - 0028
Middleburg Heights Ohio, 44130, United States
Local Institution - 0179
Perrysburg Ohio, 43551, United States
Local Institution - 0182
Oklahoma City Oklahoma, 73134, United States
Local Institution - 0185
Corvallis Oregon, 97330, United States
Local Institution - 0175
Greenville South Carolina, 29601, United States
Local Institution - 0036
Jackson Tennessee, 38305, United States
Local Institution - 0172
Allen Texas, 75013, United States
Local Institution - 0189
Amarillo Texas, 79124, United States
Local Institution - 0032
Dallas Texas, 75231, United States
Local Institution - 0273
Bothell Washington, 98021, United States
Local Institution - 0181
Beckley West Virginia, 25801, United States
Local Institution - 0213
Ciudad Autónoma de Buenos Aires Buenos Aires, 1111, Argentina
Local Institution - 0054
La Plata Buenos Aires, 1900, Argentina
Local Institution - 0192
Caba Ciudad Autónoma De Buenos Aires, 1430, Argentina
Local Institution - 0215
Quilmes Ciudad Autónoma De Buenos Aires, 1879, Argentina
Local Institution - 0046
Córdoba Cordoba, X5004, Argentina
Local Institution - 0196
Rosario Santa Fe, S2000, Argentina
Local Institution - 0047
San Miguel De Tucuman Tucuman, 4000, Argentina
Local Institution - 0194
Buenos Aires , 1426, Argentina
Local Institution - 0169
Buenos Aires , 1428, Argentina
Local Institution - 0193
Mendoza , 5500, Argentina
Local Institution - 0220
Phillip Australian Capital Territory, 2606, Australia
Local Institution - 0137
Botany New South Wales, 2019, Australia
Local Institution - 0133
Westmead New South Wales, 2145, Australia
Local Institution - 0132
Woolloongabba Queensland, 4102, Australia
Local Institution - 0211
Hobart Tasmania, 7000, Australia
Local Institution - 0136
Camberwell Victoria, 3142, Australia
Local Institution - 0001
Salvador Bahia, 40150, Brazil
Local Institution - 0109
Vitória Espirito Santo, 29055, Brazil
Local Institution - 0002
Juiz de Fora Minas Gerais, 36010, Brazil
Local Institution - 0219
Curitiba Paraná, 80030, Brazil
Local Institution - 0214
Curitiba Paraná, 80440, Brazil
Local Institution - 0005
Porto Alegre RIO Grande DO SUL, 90480, Brazil
Local Institution - 0108
Santo Andre São Paulo, 09060, Brazil
Local Institution - 0253
Burgas , 8000, Bulgaria
Local Institution - 0249
Plovdiv , 4000, Bulgaria
Local Institution - 0267
Plovdiv , 4000, Bulgaria
Local Institution - 0246
Plovdiv , 4001, Bulgaria
Local Institution - 0247
Plovdiv , 4001, Bulgaria
Local Institution - 0255
Plovdiv , 4002, Bulgaria
Local Institution - 0245
Sofia , 1505, Bulgaria
Local Institution - 0248
Sofia , 1612, Bulgaria
Local Institution - 0259
Sofia , 1784, Bulgaria
Local Institution - 0250
Varna , 9000, Bulgaria
Local Institution - 0073
Santiago Metropolitana, 75011, Chile
Local Institution - 0111
Santiago Metropolitana, 76408, Chile
Local Institution - 0226
Santiago Región Metropolitana De Santiago, 0, Chile
Local Institution - 0099
Santiago Región Metropolitana De Santiago, 75005, Chile
Local Institution - 0222
Santiago Región Metropolitana De Santiago, 75100, Chile
Local Institution - 0261
Viña del Mar Valparaíso, 25205, Chile
Local Institution - 0149
Hefei Anhui, 23007, China
Local Institution - 0159
Beijing Beijing, 10000, China
Local Institution - 0190
Chongqing Chongqing, 40001, China
Local Institution - 0147
Guangzhou Guangdong, 51012, China
Local Institution - 0143
Shenzhen Guangdong, 51802, China
Local Institution - 0150
DaLian Liaoning, 11600, China
Local Institution - 0146
Shanghai Shanghai, 20004, China
Local Institution - 0145
Yiwu Zhejiang, 32200, China
Local Institution - 0069
Bogotá Cundinamarca, 11022, Colombia
Local Institution - 0071
Bucaramanga Santander, 68000, Colombia
Local Institution - 0072
Barranquilla , 08002, Colombia
Local Institution - 0063
Bogota , 11115, Colombia
Local Institution - 0070
Cali , 76004, Colombia
Local Institution - 0094
Medellin , 05002, Colombia
Local Institution - 0064
Medellin , 05003, Colombia
Local Institution - 0065
Zipaquira , 25025, Colombia
Local Institution - 0225
Praha Praha 5, 150 0, Czechia
Local Institution - 0269
Uherske Hradiste Zlínský Kraj, 68601, Czechia
Local Institution - 0202
Zlín Zlínský Kraj, 760 0, Czechia
Local Institution - 0018
Ostrava , 722 0, Czechia
Local Institution - 0208
Pardubice , 530 0, Czechia
Local Institution - 0097
Praha 2 , 12850, Czechia
Local Institution - 0017
Praha , 130 0, Czechia
Local Institution - 0013
Helsinki , 00290, Finland
Local Institution - 0089
Kuopio , 70100, Finland
Local Institution - 0119
Turku , FI-20, Finland
Local Institution - 0077
Chambray Les Tours , 37170, France
Local Institution - 0075
Montpellier , 34295, France
Local Institution - 0074
Paris , 75010, France
Local Institution - 0270
Gyula Békés, 5700, Hungary
Local Institution - 0049
Székesfehérvár Fejér, 8000, Hungary
Local Institution - 0023
Budapest , 1027, Hungary
Local Institution - 0142
Budapest , 1027, Hungary
Local Institution - 0026
Budapest , 1033, Hungary
Local Institution - 0025
Budapest , 1036, Hungary
Local Institution - 0203
Budapest , 1036, Hungary
Local Institution - 0068
Zalaegerszeg , 8900, Hungary
Local Institution - 0104
Manorhamilton Leitrim, F91 X, Ireland
Local Institution - 0101
Dublin , 4, Ireland
Local Institution - 0102
Dublin , D15 X, Ireland
Local Institution - 0103
Galway , H91 T, Ireland
Local Institution - 0066
Genova , 16132, Italy
Local Institution - 0062
Pavia , 27100, Italy
Local Institution - 0096
Udine , 33100, Italy
Local Institution - 0058
Verona , 37134, Italy
Local Institution - 0056
Saltillo Coahuila, 25050, Mexico
Local Institution - 0227
Mexico City Distrito Federal, 03100, Mexico
Local Institution - 0209
Mexico City Distrito Federal, 14080, Mexico
Local Institution - 0057
México Distrito Federal, 06720, Mexico
Local Institution - 0254
Guadalajara Jalisco, 44610, Mexico
Local Institution - 0128
San Luis Potosí SAN LUIS Potosi, 78200, Mexico
Local Institution - 0212
Merida Yucatán, 97070, Mexico
Local Institution - 0061
Mérida Yucatán, 97070, Mexico
Local Institution - 0060
Chihuahua , 31000, Mexico
Local Institution - 0095
Veracruz , 91900, Mexico
Local Institution - 0244
Wroclaw Dolnośląskie, 50-38, Poland
Local Institution - 0232
Lublin Lubelskie, 20-60, Poland
Local Institution - 0230
Swidnik Lubelskie, 21-04, Poland
Local Institution - 0233
Nadarzyn Mazowieckie, 05-83, Poland
Local Institution - 0235
Warszawa Mazowieckie, 02-66, Poland
Local Institution - 0243
Warszawa Mazowieckie, 02-67, Poland
Local Institution - 0236
Wołomin Mazowieckie, 05-20, Poland
Local Institution - 0229
Kraków Małopolskie, 30-14, Poland
Local Institution - 0206
Nowy Targ Małopolskie, 34-40, Poland
Local Institution - 0257
Gdansk Pomorskie, 80-38, Poland
Local Institution - 0234
Gdynia Pomorskie, 81-33, Poland
Local Institution - 0231
Dąbrówka Wielkopolskie, 62-06, Poland
Local Institution - 0239
Poznan Wielkopolskie, 60-70, Poland
Local Institution - 0114
Bialystok , 15-35, Poland
Local Institution - 0140
Krakow , 31-50, Poland
Local Institution - 0126
Kraków , 30-00, Poland
Local Institution - 0127
Kraków , 30-03, Poland
Local Institution - 0162
Olsztyn , 10-11, Poland
Local Institution - 0113
Poznan , 60-21, Poland
Local Institution - 0112
Poznan , 60-77, Poland
Local Institution - 0204
Warszawa , 00-87, Poland
Local Institution - 0205
Warszawa , 02-11, Poland
Local Institution - 0125
Warszawa , 03-29, Poland
Local Institution - 0210
Wroclaw , 52-21, Poland
Local Institution - 0238
Lodz Łódzkie, 90-36, Poland
Local Institution - 0241
Czestochowa Śląskie, 42-20, Poland
Local Institution - 0252
Katowice Śląskie, 40-04, Poland
Local Institution - 0090
Bucharest București, 01117, Romania
Local Institution - 0266
Bucuresti București, 02012, Romania
Local Institution - 0012
Brasov , 50028, Romania
Local Institution - 0167
Bucharest , 01102, Romania
Local Institution - 0263
Bucharest , 03046, Romania
Local Institution - 0184
Bucharest , 11057, Romania
Local Institution - 0260
Bucuresti , 01414, Romania
Local Institution - 0011
Cluj Napoca , 40000, Romania
Local Institution - 0258
Craiova , 20034, Romania
Local Institution - 0264
Iasi , 70071, Romania
Local Institution - 0262
Iași , 70012, Romania
Local Institution - 0265
Iași , 70066, Romania
Local Institution - 0010
Râmnicu Vâlcea , 24076, Romania
Local Institution - 0091
Timisoara , 30077, Romania
Local Institution
Kemerovo , 65007, Russian Federation
Local Institution
Korolev , 14106, Russian Federation
Local Institution
Saint Petersburg , 19421, Russian Federation
Local Institution
Yaroslavl , 15000, Russian Federation
Local Institution - 0021
A Coruña , 15006, Spain
Local Institution - 0022
Cordoba , 14004, Spain
Local Institution - 0019
Madrid , 28046, Spain
Local Institution - 0020
Sabadell , 08208, Spain
Local Institution - 0123
Kaohsiung City , 83340, Taiwan
Local Institution - 0121
Tainan City , 704, Taiwan
Local Institution - 0122
Tainan , 710, Taiwan
Local Institution - 0120
Taipei City , 110, Taiwan
Local Institution - 0124
Taoyuan , 33342, Taiwan
Local Institution - 0106
Southampton Hampshire, SO16 , United Kingdom
Local Institution - 0116
Harlow , CM227, United Kingdom
Local Institution - 0107
Stoke-on-Trent , ST6 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT04908202

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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