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.
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
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There are 144 Locations for this study
Mountain Brook Alabama, 35223, United States
Fountain Valley California, 92708, United States
Sacramento California, 95815, United States
Whittier California, 90602, United States
Brandon Florida, 33511, United States
Skokie Illinois, 60076, United States
Hopkinsville Kentucky, 42240, United States
Baton Rouge Louisiana, 70836, United States
Cumberland Maryland, 21502, United States
Lansing Michigan, 48910, United States
Eagan Minnesota, 55121, United States
Hattiesburg Mississippi, 39402, United States
New York New York, 10003, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28277, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73116, United States
Portland Oregon, 97239, United States
Duncansville Pennsylvania, 16635, United States
Summerville South Carolina, 29486, United States
Lubbock Texas, 79424, United States
Mesquite Texas, 75150, United States
Plano Texas, 75024, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Franklin Wisconsin, 53132, United States
Milwaukee Wisconsin, 53217, United States
La Plata Buenos Aires, 1900, Argentina
San Isidro Buenos Aires, 1642, Argentina
Caba Distrito Federal, C1015, Argentina
San Miguel de Tucumán Tucuman, 4000, Argentina
Buenos Aires , 1426, Argentina
Buenos Aires , 1431, Argentina
Cordoba , 0, Argentina
Botany New South Wales, 2019, Australia
Paramatta New South Wales, 2150, Australia
Maroochydore Queensland, 4558, Australia
Woodville South Australia, 5011, Australia
Camberwell Victoria, 3124, Australia
Geelong Victoria, 3220, Australia
Brussels , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Vancouver British Columbia, V5Z 4, Canada
Hamilton Ontario, L8N 1, Canada
Markham Ontario, L3P 1, Canada
Toronto Ontario, M5T 2, Canada
Quebec , G1V 3, Canada
Bengbu Anhui, 23300, China
Beijing Beijing, 10008, China
Beijing Beijing, 10073, China
Guangzhou Guangdong, 51018, China
Guangzhou Guangdong, 51031, China
Shenzhen Guangdong, 51802, China
Zhengzhou Henan, 45000, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China
Changzhou Jiangsu, 21300, China
Nanjing Jiangsu, 21002, China
Nantong Jiangsu, 22600, China
Wuxi Jiangsu, 21402, China
Jiujiang Jiangxi, 33200, China
Nanchang Jiangxi, 33000, China
Nanchang Jiangxi, 33000, China
Pingxiang Jiangxi, 33705, China
Shenyang Liaoning, 11000, China
Baotou Neimeng, 01401, China
Hohhot Neimeng, 01005, China
Xi'An Shan3xi, 71000, China
Shanghai Shanghai, 20005, China
Chengdu Sichuan, 61007, China
Urumqi Xinjiang, 83000, China
Kunming Yunnan, 65003, China
Wenzhou Zhejiang, 32500, China
Barranquilla Atlántico, 08000, Colombia
Cali Valle Del Cauca, 76003, Colombia
Bogotá , 11022, Colombia
Chía , 25000, Colombia
Medellin , 50036, Colombia
Brno , 638 0, Czechia
Ostrava , 702 0, Czechia
Ostrava , 702 0, Czechia
Praha 2 , 12850, Czechia
Uherske Hradiste , 686 0, Czechia
Ratingen Nordrhein-Westfalen, 40878, Germany
Düsseldorf , 40225, Germany
Erlangen , 91054, Germany
Hamburg , 20095, Germany
Köln , 50937, Germany
Magdeburg , 39120, Germany
Minden , 32429, Germany
Tübingen , 72076, Germany
Budapest , 1062, Hungary
Debrecen , 4032, Hungary
Gyula , 5700, Hungary
Kistarcsa , 2143, Hungary
Szarvas , 6600, Hungary
Veszprem , 8200, Hungary
Firenze , 50141, Italy
Potenza , 85100, Italy
Roma , 00168, Italy
Nagoya-shi Aichi, 46786, Japan
Nagoya Aichi, 457-8, Japan
Sapporo Hokkaido, 060-8, Japan
Tsu MIE, 514-8, Japan
Kawachinagano Osaka, 586-8, Japan
Bunkyō Tokyo, 113-8, Japan
Chuo-ku Tokyo, 104-8, Japan
Itabashi-ku Tokyo, 173-0, Japan
Meguro-ku Tokyo, 15385, Japan
Minato-ku Tokyo, 105-8, Japan
Mitaka Tokyo, 181-8, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Fukuoka , 814-0, Japan
Osaka , 545-8, Japan
Osaka , 550-0, Japan
Mexico City Distrito Federal, 14080, Mexico
Leon Guanajuato, 37160, Mexico
Guadalajara Jalisco, 44650, Mexico
Zapopan Jalisco, 45070, Mexico
Merida Yucatan, 97000, Mexico
Chihuahua , 31203, Mexico
Bydgoszcz Kujawsko-pomorskie, 85-16, Poland
Warszawa Mazowieckie, 02-66, Poland
Gdansk Pomorskie, 80-54, Poland
Elblag , 82-30, Poland
Torun , 87-10, Poland
Wrocław , 50-08, Poland
Saint Petersburg Sankt-Peterburg, 19702, Russian Federation
Moscow , 10704, Russian Federation
Saint Petersburg , 19006, Russian Federation
Barcelona , 08035, Spain
Madrid , 28041, Spain
Santander , 39008, Spain
València , 46026, Spain
Taichung City , 402, Taiwan
Taichung , 40433, Taiwan
Taichung , 407, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
London England, SW17 , United Kingdom
Bradford , BD5 0, United Kingdom
Hull , HU3 2, United Kingdom
Liverpool , L9 7A, United Kingdom
London , E11 1, United Kingdom
Manchester , M13 9, United Kingdom
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