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 or Had Previously Received TNFα Inhibitor Treatment

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.

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 (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:

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:

700

Study ID:

NCT04908189

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 144 Locations for this study

See Locations Near You

Local Institution - 0149
Mountain Brook Alabama, 35223, United States
First OC Dermatology-Dermatology
Fountain Valley California, 92708, United States
Local Institution - 0212
Sacramento California, 95815, United States
Local Institution - 0188
Whittier California, 90602, United States
Bay Area Arthritis and Osteoporosis
Brandon Florida, 33511, United States
Local Institution - 0192
Skokie Illinois, 60076, United States
Local Institution - 0203
Hopkinsville Kentucky, 42240, United States
Local Institution - 0195
Baton Rouge Louisiana, 70836, United States
Local Institution - 0169
Cumberland Maryland, 21502, United States
Local Institution - 0034
Lansing Michigan, 48910, United States
Local Institution - 0133
Eagan Minnesota, 55121, United States
Local Institution - 0109
Hattiesburg Mississippi, 39402, United States
Local Institution - 0108
New York New York, 10003, United States
Local Institution - 0186
Rochester New York, 14642, United States
Local Institution - 0196
Charlotte North Carolina, 28277, United States
Local Institution - 0180
Cleveland Ohio, 44106, United States
Local Institution - 0189
Oklahoma City Oklahoma, 73116, United States
Local Institution - 0147
Portland Oregon, 97239, United States
Local Institution - 0016
Duncansville Pennsylvania, 16635, United States
Local Institution - 0182
Summerville South Carolina, 29486, United States
Local Institution - 0167
Lubbock Texas, 79424, United States
Local Institution - 0070
Mesquite Texas, 75150, United States
Local Institution - 0184
Plano Texas, 75024, United States
Local Institution - 0187
Seattle Washington, 98122, United States
University Of Washington
Seattle Washington, 98195, United States
Local Institution - 0190
Franklin Wisconsin, 53132, United States
Local Institution - 0175
Milwaukee Wisconsin, 53217, United States
Local Institution - 0048
La Plata Buenos Aires, 1900, Argentina
Local Institution - 0038
San Isidro Buenos Aires, 1642, Argentina
Local Institution - 0039
Caba Distrito Federal, C1015, Argentina
Local Institution - 0171
San Miguel de Tucumán Tucuman, 4000, Argentina
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires , 1426, Argentina
Local Institution - 0037
Buenos Aires , 1431, Argentina
Local Institution - 0168
Cordoba , 0, Argentina
Local Institution - 0003
Botany New South Wales, 2019, Australia
BJC Health
Paramatta New South Wales, 2150, Australia
Local Institution - 0004
Maroochydore Queensland, 4558, Australia
Local Institution - 0099
Woodville South Australia, 5011, Australia
Emeritus Research
Camberwell Victoria, 3124, Australia
Local Institution - 0017
Geelong Victoria, 3220, Australia
Local Institution - 0078
Brussels , 1200, Belgium
Local Institution - 0058
Gent , 9000, Belgium
Local Institution - 0104
Leuven , 3000, Belgium
Local Institution - 0061
Liège , 4000, Belgium
Local Institution - 0111
Vancouver British Columbia, V5Z 4, Canada
Local Institution - 0006
Hamilton Ontario, L8N 1, Canada
Local Institution - 0030
Markham Ontario, L3P 1, Canada
Local Institution - 0036
Toronto Ontario, M5T 2, Canada
Local Institution - 0001
Quebec , G1V 3, Canada
Local Institution - 0126
Bengbu Anhui, 23300, China
Local Institution - 0152
Beijing Beijing, 10008, China
Local Institution - 0146
Beijing Beijing, 10073, China
Local Institution - 0153
Guangzhou Guangdong, 51018, China
Local Institution - 0135
Guangzhou Guangdong, 51031, China
Local Institution - 0206
Shenzhen Guangdong, 51802, China
Local Institution - 0127
Zhengzhou Henan, 45000, China
Local Institution - 0170
Changsha Hunan, 41000, China
Local Institution - 0161
Changsha Hunan, 41001, China
Local Institution - 0125
Changzhou Jiangsu, 21300, China
Local Institution - 0138
Nanjing Jiangsu, 21002, China
Local Institution - 0139
Nantong Jiangsu, 22600, China
Local Institution - 0163
Wuxi Jiangsu, 21402, China
Local Institution - 0148
Jiujiang Jiangxi, 33200, China
Local Institution - 0131
Nanchang Jiangxi, 33000, China
Local Institution - 0156
Nanchang Jiangxi, 33000, China
Local Institution - 0140
Pingxiang Jiangxi, 33705, China
Local Institution - 0191
Shenyang Liaoning, 11000, China
Local Institution - 0158
Baotou Neimeng, 01401, China
Local Institution - 0157
Hohhot Neimeng, 01005, China
Local Institution - 0154
Xi'An Shan3xi, 71000, China
Local Institution - 0207
Shanghai Shanghai, 20005, China
Local Institution - 0164
Chengdu Sichuan, 61007, China
Local Institution - 0117
Urumqi Xinjiang, 83000, China
Local Institution - 0134
Kunming Yunnan, 65003, China
Local Institution - 0129
Wenzhou Zhejiang, 32500, China
Local Institution - 0072
Barranquilla Atlántico, 08000, Colombia
Local Institution - 0020
Cali Valle Del Cauca, 76003, Colombia
Local Institution - 0015
Bogotá , 11022, Colombia
Local Institution - 0022
Chía , 25000, Colombia
Local Institution - 0019
Medellin , 50036, Colombia
Local Institution - 0010
Brno , 638 0, Czechia
Local Institution - 0009
Ostrava , 702 0, Czechia
Local Institution - 0035
Ostrava , 702 0, Czechia
Local Institution - 0011
Praha 2 , 12850, Czechia
Local Institution - 0023
Uherske Hradiste , 686 0, Czechia
Local Institution - 0176
Ratingen Nordrhein-Westfalen, 40878, Germany
Local Institution - 0100
Düsseldorf , 40225, Germany
Local Institution - 0199
Erlangen , 91054, Germany
Local Institution - 0046
Hamburg , 20095, Germany
Local Institution - 0101
Köln , 50937, Germany
Local Institution - 0075
Magdeburg , 39120, Germany
Local Institution - 0201
Minden , 32429, Germany
Local Institution - 0074
Tübingen , 72076, Germany
Local Institution - 0197
Budapest , 1062, Hungary
Local Institution - 0066
Debrecen , 4032, Hungary
Local Institution - 0028
Gyula , 5700, Hungary
Local Institution - 0027
Kistarcsa , 2143, Hungary
Local Institution - 0024
Szarvas , 6600, Hungary
Local Institution - 0025
Veszprem , 8200, Hungary
Azienda Ospedaliera Universitaria Careggi-Reumatologia
Firenze , 50141, Italy
AOR San Carlo di Potenza-UOC Reumatologia
Potenza , 85100, Italy
Local Institution - 0097
Roma , 00168, Italy
Local Institution - 0106
Nagoya-shi Aichi, 46786, Japan
Local Institution - 0202
Nagoya Aichi, 457-8, Japan
Local Institution - 0151
Sapporo Hokkaido, 060-8, Japan
Local Institution - 0179
Tsu MIE, 514-8, Japan
Local Institution - 0123
Kawachinagano Osaka, 586-8, Japan
Local Institution - 0205
Bunkyō Tokyo, 113-8, Japan
Local Institution - 0121
Chuo-ku Tokyo, 104-8, Japan
Local Institution - 0067
Itabashi-ku Tokyo, 173-0, Japan
Local Institution - 0178
Meguro-ku Tokyo, 15385, Japan
Local Institution - 0122
Minato-ku Tokyo, 105-8, Japan
Local Institution - 0174
Mitaka Tokyo, 181-8, Japan
Local Institution - 0065
Shinjuku-ku Tokyo, 160-8, Japan
Local Institution - 0155
Fukuoka , 814-0, Japan
Local Institution - 0166
Osaka , 545-8, Japan
Local Institution - 0204
Osaka , 550-0, Japan
Local Institution - 0198
Mexico City Distrito Federal, 14080, Mexico
Local Institution - 0052
Leon Guanajuato, 37160, Mexico
Local Institution - 0051
Guadalajara Jalisco, 44650, Mexico
Local Institution - 0057
Zapopan Jalisco, 45070, Mexico
Local Institution - 0056
Merida Yucatan, 97000, Mexico
Local Institution - 0053
Chihuahua , 31203, Mexico
Local Institution - 0082
Bydgoszcz Kujawsko-pomorskie, 85-16, Poland
Local Institution - 0177
Warszawa Mazowieckie, 02-66, Poland
Local Institution - 0079
Gdansk Pomorskie, 80-54, Poland
Local Institution - 0080
Elblag , 82-30, Poland
Local Institution - 0081
Torun , 87-10, Poland
Local Institution - 0112
Wrocław , 50-08, Poland
Local Institution - 0208
Saint Petersburg Sankt-Peterburg, 19702, Russian Federation
Local Institution
Moscow , 10704, Russian Federation
Local Institution - 0145
Saint Petersburg , 19006, Russian Federation
Local Institution - 0014
Barcelona , 08035, Spain
Local Institution - 0012
Madrid , 28041, Spain
Local Institution - 0045
Santander , 39008, Spain
Local Institution - 0013
València , 46026, Spain
Local Institution - 0090
Taichung City , 402, Taiwan
Local Institution - 0088
Taichung , 40433, Taiwan
Local Institution - 0089
Taichung , 407, Taiwan
Local Institution - 0091
Taipei , 10002, Taiwan
Local Institution - 0087
Taipei , 11217, Taiwan
Local Institution - 0185
London England, SW17 , United Kingdom
Local Institution - 0060
Bradford , BD5 0, United Kingdom
Local Institution - 0064
Hull , HU3 2, United Kingdom
Local Institution - 0077
Liverpool , L9 7A, United Kingdom
Local Institution - 0062
London , E11 1, United Kingdom
Local Institution - 0105
Manchester , M13 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT04908189

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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