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:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 182 Locations for this study

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Arizona Arthritis & Rheumatology Associates
Gilbert Arizona, 85297, United States More Info
Joonhee Lim, Site 0197
Contact
000-000-0000
Arthritis and Rheumatism Associates (ARA) - Jonesboro
Jonesboro Arkansas, 72401, United States More Info
BEATA FILIP-MAJEWSKI, Site 0188
Contact
111-111-1111
Kaiser Permanente-Rheumatology
Fontana California, 92335, United States More Info
Steve Lee, Site 0168
Contact
818-634-5534
Local Institution
Fountain Valley California, 92708, United States More Info
Site 0092
Contact
Providence Medical Foundation
Fullerton California, 92835, United States More Info
Shirley Pang, Site 0199
Contact
714-833-4831
Local Institution
Palm Desert California, 92260, United States More Info
Site 0035
Contact
Integrative Skin Science and Research
Sacramento California, 95815, United States More Info
Raja Sivamani, Site 0038
Contact
510-847-6713
Cohen Medical Centers
Thousand Oaks California, 91360, United States More Info
Shariar Cohen-Gadol, Site 0187
Contact
310-709-3564
Denver Arthritis Clinic - Lowry
Denver Colorado, 80230, United States More Info
Christopher Antolini, Site 0170
Contact
303-394-2828
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater Florida, 33765, United States More Info
Robert Levin, Site 0195
Contact
727-466-0078
San Marcus Research Clinic, Inc.
Miami Lakes Florida, 33014, United States More Info
Hector Naranjo Lopez, Site 0082
Contact
305-424-7420
Arthritis Center of North Georgia
Gainesville Georgia, 30501, United States More Info
Brent Flickinger, Site 0171
Contact
770-531-3711
St. Luke's Intermountain Research Center-St. Luke's Clinic - Rheumatology
Boise Idaho, 83702, United States More Info
James Loveless, Site 0087
Contact
208-706-5930
Great Lakes Clinical Trials - Ravenswood
Chicago Illinois, 60640, United States More Info
Manish Jain, Site 0080
Contact
847-826-7658
Greater Chicago Specialty Physicians - Orland Park
Orland Park Illinois, 60467, United States More Info
Cory Conniff, Site 0177
Contact
847-599-2492
Greater Chicago Specialty Physicians
Schaumburg Illinois, 60195, United States More Info
Kamran Chaudhary, Site 0178
Contact
847-599-2492
Arthritis Center of Lexington-Bluegrass Community Research, Inc.
Lexington Kentucky, 40504, United States More Info
Jeffrey Neal, Site 0083
Contact
Klein & Associates, M.D., P.A.
Hagerstown Maryland, 21740, United States More Info
Mary Howell, Site 0042
Contact
301-791-6680
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Alireza Meysami, Site 0198
Contact
313-622-4386
Clinvest Research LLC
Springfield Missouri, 65807, United States More Info
David True, Site 0201
Contact
417-883-7889
Local Institution
Toms River New Jersey, 08755, United States More Info
Site 0081
Contact
Arthritis, Rheumatic & Bone Disease Associates, Affiliate of Trabecular Medical Group, LLC
Voorhees New Jersey, 08043, United States More Info
Mugdha Agrawal, Site 0186
Contact
856-424-5005
University Hospitals Cleveland Medical Center-Dermatology
Cleveland Ohio, 44106, United States More Info
Neil Korman, Site 0033
Contact
216-844-5197
Paramount Medical Research & Consulting, Llc
Middleburg Heights Ohio, 44130, United States More Info
Isam Diab, Site 0028
Contact
440-915-5759
Clinical Research Source, Inc
Perrysburg Ohio, 43551, United States More Info
Edward Goldberger, Site 0179
Contact
419-873-1532
Hightower Clinical Trial Services
Oklahoma City Oklahoma, 73114, United States More Info
Fahed Hamadeh, Site 0182
Contact
405-830-7583
Good Samaritan Hospital Corvallis
Corvallis Oregon, 97330, United States More Info
Jonathan Jones, Site 0185
Contact
603-727-6032
Piedmont Arthritis Clinic
Greenville South Carolina, 29601, United States More Info
Long Huynh-Duc, Site 0175
Contact
864-235-8396
West Tennessee Research Institute
Jackson Tennessee, 38305, United States More Info
Jacob Aelion, Site 0036
Contact
731-664-0002
Arthritis & Rheumatology Research Institute
Allen Texas, 75013, United States More Info
Megha Patel-Banker, Site 0172
Contact
516-859-2951
Amarillo Center for Clinical Research-Research
Amarillo Texas, 79124, United States More Info
Nicole Davey-Ranasinghe, Site 0189
Contact
806-353-7000
Metroplex Clinical Research Center
Dallas Texas, 75231, United States More Info
Roy Fleischmann, Site 0032
Contact
214-879-6737
Rheumatology & Pulmonary Clinic
Beckley West Virginia, 25801, United States More Info
Wassim Saikali, Site 0181
Contact
304-237-1199
Local Institution - 0054
La Plata Buenos Aires, 1900, Argentina More Info
Site 0054
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Clinica Adventista Belgrano
Caba Ciudad Autónoma De Buenos Aires, C1430, Argentina More Info
Federico Ariel, Site 0192
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+5491124691447
Local Institution - 0215
Quilmes Ciudad Autónoma De Buenos Aires, 1879, Argentina More Info
Site 0215
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Hospital Cordoba
Córdoba Cordoba, X5004, Argentina More Info
Veronica Savio, Site 0046
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+5493515337844
Local Institution
DQG Distrito Federal, C1428, Argentina
Local Institution - 0196
Rosario Santa Fe, S2000, Argentina More Info
Site 0196
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Centro Medico Privado de Reumatologia
San Miguel De Tucuman Tucuman, 4000, Argentina More Info
Walter Spindler, Site 0047
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+5493815537820
Local Institution - 0048
Buenos Aires , 1194, Argentina
Consultorios Reumatológicos Pampa
Buenos Aires , 1428, Argentina More Info
Maria Correa, Site 0169
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91154743534
Local Institution - 0213
Ciudad Autónoma de Buenos Aires , C1111, Argentina More Info
Site 0213
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Cordoba , , Argentina More Info
Site 0165
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Instituto de Reumatología
Mendoza , 5500, Argentina More Info
ALFREDO BORGIA, Site 0193
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+5492615440980
Local Institution - 0220
Phillip Australian Capital Territory, 2606, Australia More Info
Site 0220
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Local Institution - 0137
Botany New South Wales, 2019, Australia More Info
Site 0137
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Local Institution - 0133
Westmead New South Wales, 2145, Australia More Info
Site 0133
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Local Institution - 0132
Woolloongabba Queensland, 4102, Australia More Info
Site 0132
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Hobart Tasmania, 7000, Australia More Info
Site 0211
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Camberwell Victoria, 3142, Australia More Info
Site 0136
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Clayton Victoria, 3168, Australia More Info
Site 0163
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Local Institution - 0001
Salvador Bahia, 40150, Brazil More Info
Site 0001
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Local Institution - 0109
Vitória Espirito Santo, 29055, Brazil More Info
Site 0109
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Juiz de Fora Minas Gerais, 36010, Brazil More Info
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Curitiba Paraná, 80030, Brazil More Info
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Curitiba Paraná, 80440, Brazil More Info
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Porto Alegre RIO Grande DO SUL, 90480, Brazil More Info
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Sao Paulo , 09060, Brazil More Info
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Local Institution - 0248
Sofia Sofia (stolitsa), 1612, Bulgaria More Info
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Local Institution - 0253
Burgas , 8000, Bulgaria More Info
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Local Institution - 0249
Plovdiv , 4000, Bulgaria More Info
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Plovdiv , 4000, Bulgaria More Info
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Plovdiv , 4001, Bulgaria More Info
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Plovdiv , 4001, Bulgaria More Info
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Plovdiv , 4002, Bulgaria More Info
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Sofia , 1505, Bulgaria More Info
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Sofia , 1784, Bulgaria More Info
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Varna , 9000, Bulgaria More Info
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Santiago Metropolitana, 75005, Chile More Info
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Local Institution - 0073
Santiago Metropolitana, 75011, Chile More Info
Site 0073
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Local Institution - 0111
Santiago Metropolitana, 76408, Chile More Info
Site 0111
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Centro Internacional de Estudios Clinicos (CIEC)
Santiago Región Metropolitana De Santiago, 0, Chile
Local Institution - 0226
Santiago Región Metropolitana De Santiago, 0, Chile More Info
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Santiago Región Metropolitana De Santiago, 75100, Chile More Info
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Viña del Mar Valparaíso, 25205, Chile More Info
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Hefei Anhui, 23007, China More Info
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Beijing Beijing, 10000, China More Info
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Chongqing Chongqing, 40001, China More Info
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Local Institution - 0147
Guangzhou Guangdong, 51012, China More Info
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Shenzhen Guangdong, 51802, China More Info
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DaLian Liaoning, 11600, China More Info
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Shanghai Shanghai, 20004, China More Info
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Yiwu Zhejiang, 32200, China More Info
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Local Institution - 0069
Bogotá Cundinamarca, 11022, Colombia More Info
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Bucaramanga Santander, 0, Colombia More Info
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Barranquilla , 08002, Colombia More Info
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Bogota , 11115, Colombia More Info
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Cali , 76004, Colombia More Info
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Medellin , 05003, Colombia More Info
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Zipaquira , 25025, Colombia More Info
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Praha Praha 5, 150 0, Czechia More Info
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Zlín Zlínský Kraj, 760 0, Czechia More Info
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Ostrava , 722 0, Czechia More Info
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Pardubice , 530 0, Czechia More Info
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Pardubice , 530 0, Czechia
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Prague , 13000, Czechia More Info
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Praha 2 , 12850, Czechia More Info
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Helsinki , 00290, Finland More Info
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Local Institution - 0089
Kuopio , 70100, Finland More Info
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Local Institution - 0119
Turku , FI-20, Finland More Info
Site 0119
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CHRU Troussau-Rhumatologie
Chambray Les Tours , 37170, France More Info
Philippe Goupille, Site 0077
Contact
+332474747
CHU Montpellier Lapeyronie Hospital-Rhumatologie
Montpellier , 34295, France More Info
Jacques Morel, Site 0075
Contact
111-111-1111
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière-RHEUMATOLOGIE
Paris , 75010, France More Info
Pascal Richette, Site 0074
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+33149956290
Local Institution - 0049
Székesfehérvár Fejér, 8000, Hungary More Info
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Local Institution - 0142
Budapest , 1023, Hungary More Info
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Budapest , 1027, Hungary More Info
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Budapest , 1033, Hungary More Info
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Budapest , 1036, Hungary More Info
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Zalaegerszeg , 8900, Hungary More Info
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Manorhamilton Leitrim, F91 X, Ireland More Info
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Dublin , D15 X, Ireland More Info
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Genova , 16132, Italy More Info
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Pavia , 27100, Italy More Info
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Udine , 33100, Italy More Info
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Verona , 37134, Italy More Info
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Saltillo Coahuila, 25020, Mexico More Info
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Ciudad de México Distrito Federal, 06700, Mexico More Info
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Mexico City Distrito Federal, 03100, Mexico More Info
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Mexico City Distrito Federal, 14080, Mexico More Info
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Guadalajara Jalisco, 44610, Mexico More Info
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San Luis Potosí SAN LUIS Potosi, 78200, Mexico More Info
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Mérida Yucatan, 97070, Mexico More Info
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Merida Yucatán, 97070, Mexico More Info
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Chihuahua , 31000, Mexico More Info
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Veracruz , 91900, Mexico More Info
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Wroclaw Dolnośląskie, 50-38, Poland More Info
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Lublin Lubelskie, 20-60, Poland More Info
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Swidnik Lubelskie, 21-04, Poland More Info
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Nadarzyn Mazowieckie, 05-83, Poland More Info
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Warsaw Mazowieckie, 01-19, Poland More Info
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Warszawa Mazowieckie, 02-66, Poland More Info
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Wolomin Mazowieckie, 05-20, Poland More Info
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Kraków Małopolskie, 30-14, Poland More Info
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Nowy Targ Małopolskie, 34-40, Poland More Info
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Gdansk Pomorskie, 80-38, Poland More Info
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Gdynia Pomorskie, 31-33, Poland More Info
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Dąbrówka Wielkopolskie, 62-06, Poland More Info
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Krakow , 31-50, Poland More Info
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Kraków , 30-00, Poland More Info
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Warszawa , 00-87, Poland More Info
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Wroclaw , 52-41, Poland
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Lodz Łódzkie, 90-36, Poland More Info
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Bucuresti București, 02012, Romania More Info
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Bucuresti București, 30463, Romania More Info
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Iasi Iași, 70702, Romania More Info
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Brasov , 50028, Romania More Info
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Bucharest , 01102, Romania More Info
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Bucharest , 01117, Romania More Info
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Bucharest , 11057, Romania More Info
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Bucuresti , 01414, Romania More Info
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Cluj Napoca , 40000, Romania More Info
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Craiova , 20034, Romania More Info
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Iași , 70066, Romania More Info
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Iași , 70071, Romania More Info
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Râmnicu Vâlcea , 24076, Romania More Info
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Timisoara , 30077, Romania More Info
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Chelyabinsk , 45404, Russian Federation
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Kazan , 42010, Russian Federation
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Kemerovo , 65007, Russian Federation
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Korolev , 14106, Russian Federation
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Korolev , 14106, Russian Federation
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Moscow , 11552, Russian Federation
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Novosibirsk , 63000, Russian Federation
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Ryazan , 39002, Russian Federation
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Saint Petersburg , 19421, Russian Federation
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Saratov , 41005, Russian Federation
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Yaroslavl , 15000, Russian Federation
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A Coruña , 15006, Spain More Info
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Cordoba , 14004, Spain More Info
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Madrid , 28046, Spain More Info
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Sabadell , 08208, Spain More Info
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Kaohsiung City , 83340, Taiwan More Info
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Tainan City , 704, Taiwan More Info
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Tainan , 710, Taiwan More Info
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Taipei City , 110, Taiwan More Info
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Taoyuan , 33342, Taiwan More Info
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Southampton Hampshire, SO16 , United Kingdom More Info
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Harlow , CM227, United Kingdom More Info
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Local Institution - 0107
Stoke-on-Trent , ST6 7, United Kingdom More Info
Site 0107
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How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

650

Study ID:

NCT04908202

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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