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:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 146 Locations for this study

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Rheumatology Associates
Mountain Brook Alabama, 35223, United States More Info
Anthony Turkiewicz, Site 0149
Contact
205-933-0320
Integrative Skin Science and Research - Location 2
Sacramento California, 95815, United States More Info
Raja Sivamani, Site 0212
Contact
510-847-6713
Medvin Clinical Research - Su
Whittier California, 90602, United States More Info
Tien-I Su, Site 0188
Contact
562-758-6600
Clinic of Robert Hozman, MD/Clinical Investigation Specialists, Inc.
Skokie Illinois, 60076, United States More Info
Robert Hozman, Site 0192
Contact
847-673-8473
Western KY Rheumatology
Hopkinsville Kentucky, 42240, United States More Info
Kishorkumar Desai, Site 0203
Contact
270-885-3876
Ochsner Medical Complex - The Grove
Baton Rouge Louisiana, 70836, United States More Info
Saravanan Thiagarajan, MD, Site 0195
Contact
225-761-5278
Klein And Associates, M.D., Pa
Cumberland Maryland, 21502, United States More Info
Steven Klein, Site 0169
Contact
301-724-4337
Advanced Rheumatology, PC
Lansing Michigan, 48910, United States More Info
Monika Mohan, Site 0034
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Saint Paul Rheumatology
Eagan Minnesota, 55121, United States More Info
Elvia Moreta, Site 0133
Contact
651-361-8659
Arthritis Associates
Hattiesburg Mississippi, 39402, United States More Info
David Weiss, Site 0109
Contact
601-582-7655
Icahn School of Medicine at Mount Sinai-Department of Dermatology
New York New York, 10003, United States More Info
Alice Gottlieb, Site 0108
Contact
212-844-8625
University of Rochester Medical Center
Rochester New York, 14642, United States More Info
Christopher Ritchlin, Site 0186
Contact
585-451-2125
OnSite Clinical Solutions
Charlotte North Carolina, 28277, United States More Info
Rakesh Patel, Site 0196
Contact
704-647-9913
University Hospitals Cleveland Medical Center-Medicine
Cleveland Ohio, 44106, United States More Info
Marina Magrey, Site 0180
Contact
216-409-5894
RAO Research LLC
Oklahoma City Oklahoma, 73116, United States More Info
Latisha Heinlen, Site 0189
Contact
405-608-8060
OHSU Center for Hematologic Malignancies
Portland Oregon, 97239, United States More Info
Atulya Deodhar, Site 0147
Contact
503-494-7711
Altoona Center For Clinical Research
Duncansville Pennsylvania, 16635, United States More Info
Alan Kivitz, Site 0016
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814-934-4368
Low Country Rheumatology
Summerville South Carolina, 29486, United States More Info
Jennifer Murphy, Site 0182
Contact
843-572-1818
West Texas Clinical Research
Lubbock Texas, 79424, United States More Info
Jitendra Vasandani, Site 0167
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806-993-1040
Local Institution - 0070
Mesquite Texas, 75150, United States
Trinity Universal Research Associates
Plano Texas, 75024, United States More Info
Fehmida Zahabi Unwala, Site 0184
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214-726-6721
Swedish Medical Center
Seattle Washington, 98122, United States More Info
Philip Mease, Site 0187
Contact
206-386-2000
Aurora Rheumatology
Franklin Wisconsin, 53132, United States More Info
Alvin Wells, Site 0190
Contact
414-916-0400
Rheumatic Disease Center
Milwaukee Wisconsin, 53217, United States More Info
Kurt Oelke, Site 0175
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414-351-4009
Local Institution - 0048
La Plata Buenos Aires, 1900, Argentina More Info
Site 0048
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Local Institution - 0038
San Isidro Buenos Aires, 1642, Argentina More Info
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Local Institution - 0039
Caba Distrito Federal, C1015, Argentina More Info
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Local Institution - 0171
San Miguel de Tucumán Tucuman, 4000, Argentina More Info
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Local Institution - 0200
Buenos Aires , 1426, Argentina More Info
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Cordoba , , Argentina More Info
Site 0168
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Emeritus Research
Botany New South Wales, 2019, Australia More Info
Paul Bird, Site 0003
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+61280842349
BJC Health
Paramatta New South Wales, 2150, Australia More Info
Andrew Jordan, Site 0018
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+61423046927
Local Institution - 0004
Maroochydore Queensland, 4558, Australia More Info
Site 0004
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Local Institution - 0099
Woodville South Australia, 5011, Australia More Info
Site 0099
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Emeritus Research
Camberwell Victoria, 3124, Australia More Info
Stephen Hall, Site 0002
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(+61 3)95096166
Local Institution - 0017
Geelong Victoria, 3220, Australia More Info
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Local Institution - 0078
Brussels , 1200, Belgium More Info
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Local Institution - 0058
Gent , 9000, Belgium More Info
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Liège , 4000, Belgium More Info
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Vancouver British Columbia, V5Z 4, Canada More Info
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Hamilton Ontario, L8N 1, Canada More Info
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Markham Ontario, L3P 1, Canada More Info
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Toronto Ontario, M5T 2, Canada More Info
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Waterloo Ontario, N2J 1, Canada More Info
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Quebec , G1V 3, Canada More Info
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Bengbu Anhui, 23300, China More Info
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Beijing Beijing, 10008, China More Info
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Beijing Beijing, 10073, China More Info
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Guangzhou Guangdong, 51018, China More Info
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Local Institution - 0135
Guangzhou Guangdong, 51031, China More Info
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Shenzhen Guangdong, 51802, China More Info
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Zhengzhou Henan, 45000, China More Info
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Local Institution - 0170
Changsha Hunan, 41000, China More Info
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Changsha Hunan, 41002, China More Info
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Local Institution - 0125
Changzhou Jiangsu, 21300, China More Info
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Local Institution - 0138
Nanjing Jiangsu, 21002, China More Info
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Nantong Jiangsu, 22600, China More Info
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Wuxi Jiangsu, 21402, China More Info
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Local Institution - 0148
Jiujiang Jiangxi, 33200, China More Info
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Local Institution - 0131
Nanchang Jiangxi, 33000, China More Info
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Nanchang Jiangxi, 33000, China More Info
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Local Institution - 0140
Pingxiang Jiangxi, 33705, China More Info
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Local Institution - 0158
Baotou Neimeng, 01401, China More Info
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Local Institution - 0157
Hohhot Neimeng, 01005, China More Info
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Xi'An Shan3xi, 71000, China More Info
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Local Institution - 0207
Shanghai Shanghai, 20005, China More Info
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Chengdu Sichuan, 61007, China More Info
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Local Institution - 0117
Urumqi Xinjiang, 83000, China More Info
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Kunming Yunnan, 65003, China More Info
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Local Institution - 0129
Wenzhou Zhejiang, 32500, China More Info
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Local Institution - 0020
Cali Valle Del Cauca, 76003, Colombia More Info
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Local Institution - 0072
Barranquilla , 80002, Colombia More Info
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Local Institution - 0015
Bogotá , 11022, Colombia More Info
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Local Institution - 0022
Chía , 25000, Colombia More Info
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Local Institution - 0019
Medellin , 50036, Colombia More Info
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Local Institution - 0010
Brno , 638 0, Czechia More Info
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Local Institution - 0009
Ostrava , 702 0, Czechia More Info
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Local Institution - 0035
Ostrava , 702 0, Czechia More Info
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Local Institution - 0011
Praha 2 , 12850, Czechia More Info
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Local Institution - 0023
Uherske Hradiste , 686 0, Czechia More Info
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Local Institution - 0176
Ratingen Nordrhein-Westfalen, 40878, Germany More Info
Site 0176
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Bonn , 53127, Germany More Info
Site 0047
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Local Institution - 0199
Erlangen , 91054, Germany More Info
Site 0199
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Gera , 07548, Germany More Info
Site 0049
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Local Institution - 0046
Hamburg , 20095, Germany More Info
Site 0046
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Hamburg , 22391, Germany
Universitaetsklinikum Koeln-Medizinische Klinik I fuer Innere Medizin
Köln , 50937, Germany More Info
David Kofler, Site 0101
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+4922147898690
Local Institution - 0075
Magdeburg , 39120, Germany
Local Institution - 0201
Minden , 32429, Germany More Info
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Local Institution - 0074
Tübingen , 72076, Germany More Info
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Local Institution - 0197
Budapest , 1062, Hungary More Info
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Local Institution - 0066
Debrecen , 4032, Hungary More Info
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Local Institution - 0028
Gyula , 5700, Hungary More Info
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Kistarcsa , 2143, Hungary More Info
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Szarvas , 6600, Hungary More Info
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Local Institution - 0025
Veszprem , 8200, Hungary More Info
Site 0025
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Azienda Ospedaliera Universitaria Careggi-Reumatologia
Firenze , 50141, Italy More Info
Serena Guiducci, Site 0092
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0557946457
AOR San Carlo di Potenza-UOC Reumatologia
Potenza , 85100, Italy More Info
Salvatore D'Angelo, Site 0098
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+393478897030
Fondazione Policlinico Universitario Agostino Gemelli-UOC Reumatologia
Roma , 00168, Italy More Info
MARIA ANTONIETTA D'AGOSTINO, Site 0097
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+393495458711
Local Institution - 0106
Nagoya-shi Aichi, 46786, Japan More Info
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Nagoya Aichi, 457-8, Japan More Info
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Fukuoka, Jonan-Ku Fukuoka, 814-0, Japan More Info
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Sapporo Hokkaido, 060-8, Japan More Info
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Tsu MIE, 514-8, Japan More Info
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Kawachinagano Osaka, 586-8, Japan More Info
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Bunkyō Tokyo, 113-8, Japan More Info
Site 0205
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Local Institution - 0121
Chuo-ku Tokyo, 104-8, Japan More Info
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Local Institution - 0067
Itabashi-ku Tokyo, 173-0, Japan More Info
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Meguro-ku Tokyo, 153-8, Japan More Info
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Minato-ku Tokyo, 105-8, Japan More Info
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Mitaka Tokyo, 181-8, Japan More Info
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Shinjuku-ku Tokyo, 160-8, Japan More Info
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Osaka , 545-8, Japan More Info
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Osaka , 550-0, Japan More Info
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Mexico City Distrito Federal, 14080, Mexico More Info
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Leon Guanajuato, 37160, Mexico More Info
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Guadalajara Jalisco, 44650, Mexico More Info
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Zapopan Jalisco, 45070, Mexico More Info
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Merida Yucatan, 97000, Mexico More Info
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Chihuahua , 31203, Mexico More Info
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Bydgoszcz Kujawsko-pomorskie, 85-16, Poland More Info
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Local Institution - 0177
Warszawa Mazowieckie, 02-66, Poland More Info
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Elblag , 82-30, Poland More Info
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Gdansk , 80-54, Poland More Info
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Torun , 87-10, Poland More Info
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Wrocław , 50-08, Poland More Info
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Ekaterinburg , 62010, Russian Federation
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Kazan , 42009, Russian Federation
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Moscow , 10704, Russian Federation
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Moscow , 12146, Russian Federation
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Novosibirsk , 63004, Russian Federation
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Novosibirsk , 63009, Russian Federation
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Saint Petersburg , 19421, Russian Federation
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Saint-Petersburg , 19702, Russian Federation
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Vladimir , 60002, Russian Federation
Local Institution - 0014
Barcelona , 08035, Spain More Info
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Local Institution - 0012
Madrid , 28041, Spain More Info
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Santander , 39008, Spain More Info
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València , 46026, Spain More Info
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Taichung City , 402, Taiwan More Info
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Taichung , 40433, Taiwan More Info
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Taichung , 407, Taiwan More Info
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Taipei , 10002, Taiwan More Info
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Taipei , 11217, Taiwan More Info
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London England, SW17 , United Kingdom More Info
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Bradford , BD5 0, United Kingdom More Info
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Hull , HU3 2, United Kingdom More Info
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Liverpool , L9 7A, United Kingdom More Info
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London , E11 1, United Kingdom More Info
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Local Institution - 0105
Manchester , M13 9, United Kingdom More Info
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How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

700

Study ID:

NCT04908189

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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