Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
NCT ID: NCT03624127
Last Updated: 2023-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
666 participants
INTERVENTIONAL
2018-08-07
2020-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986165
BMS-986165
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Apremilast
Apremilast
Specified dose on specified days
Interventions
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BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Apremilast
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe disease
* Candidate for phototherapy or systemic therapy
Exclusion Criteria
* History of recent infection
* Prior exposure to BMS-986165 or active comparator
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Achieve Clinical Research
Birmingham, Alabama, United States
Coastal Clinical Research - Mobile
Mobile, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Synexus - Tucson
Tucson, Arizona, United States
Hull Dermatology
Rogers, Arkansas, United States
First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley
Fountain Valley, California, United States
University California at Irvine Dermatology Clinical Research Center
Irvine, California, United States
Keck School of Medicine
Los Angeles, California, United States
Dream Team Clinical Research
Pomona, California, United States
University Dermatology Group
San Diego, California, United States
Unison Clinical Trials
Sherman Oaks, California, United States
New England Research Associates
Bridgeport, Connecticut, United States
Precision Clinical Research
Davie, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
LCC Medical Research
Miami, Florida, United States
International Dermatology Research
Miami, Florida, United States
Well Pharma Medical Research
Miami, Florida, United States
Miami Dade Medical Research Institute
Miami, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Ameriderm Research
Ormond Beach, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Hamilton Dermatology
Alpharetta, Georgia, United States
Healthcare Research Network - Flossmoor
Flossmoor, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
The Dermatology Center
New Albany, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Kansas City Dermatology
Overland Park, Kansas, United States
Dermatology Specialists Research-Kentucky
Louisville, Kentucky, United States
Clinical Trials of America - Monroe
Monroe, Louisiana, United States
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States
ActivMed Practices and Research - Beverly
Beverly, Massachusetts, United States
DermCare Experts
Quincy, Massachusetts, United States
David Fivenson MD Dermatology
Ann Arbor, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Associated Skin Care Specialists - Minnesota Clinical Study Center
New Brighton, Minnesota, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hassman Research Institute
Berlin, New Jersey, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Mount Sinai - Queens
New York, New York, United States
PMG Research of Charlotte
Charlotte, North Carolina, United States
Duke University Health System - Duke Clinic
Durham, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Synexus - Columbus
Columbus, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States
Synexus Clinical Research - Anderson
Anderson, South Carolina, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Interspond - Stones River Dermatology - Murfreesboro Office
Murfreesboro, Tennessee, United States
Westlake Dermatology - Westlake
Austin, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Austin Institute for Clinical Research - Pflugerville
Pflugerville, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Interspond - Acclaim Dermatology
Sugar Land, Texas, United States
Center for Clinical Studies - Webster
Webster, Texas, United States
Dermatology Associates of Seattle
Seattle, Washington, United States
Eastern Washington Dermatology
Walla Walla, Washington, United States
Kirk Barber Research
Calgary, Alberta, Canada
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Office of Dr. Arnon Moshe Katz
Newmarket, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
Skin Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology - Richmond Hill
Richmond Hill, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Docteur David Gratton Dermatologue
Montreal, Quebec, Canada
Siena Medical Research
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, Canada
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Wuhan, Hubei, China
Local Institution
Hangzhou, Zhejiang, China
Charite Universitatsmedizin Berlin
Berlin, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Local Institution - 0165
Nagoya, Aichi-ken, Japan
Local Institution - 0181
Toon-Shi, Ehime, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, Japan
Sapporo Skin Clinic
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Local Institution - 0182
Isehara, Kanagawa, Japan
Local Institution - 0169
Yokohama, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nakoku, Kochi, Japan
University Hospital - Kyoto Preferctural University of Medicine
Kyoto, Kyoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Local Institution - 0166
Matsumoto, Nagano, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Teikyo University Hospital
Itabashi-Ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
The Jikei University Hospital
Minato-ku, Tokyo, Japan
Local Institution - 0188
Shinagawa, Tokyo, Japan
Local Institution - 0108
Shinjuku, Tokyo, Japan
Local Institution - 0175
Shinjuku-Ku, Tokyo, Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Local Institution - 0167
Osaka, , Japan
Local Institution - 0160
Osaka, , Japan
Local Institution - 0191
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0201
Bialystok, , Poland
Local Institution - 0144
Gdynia, , Poland
Synexus - Katowice
Katowice, , Poland
Local Institution - 0079
Krak, , Poland
Centrum Terapii Wspolczesnej
Lodz, , Poland
Centrum Medyczne All-Med
Lodz, , Poland
Miejski Szpital Zespolony w Olsztynie
Olsztyn, , Poland
DermoDent - Centrum Medyczne Czajkowscy
Osielsko, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Local Institution - 0200
Poznan, , Poland
Clinical Research Group
Warsaw, , Poland
Center for Clinical Studies - Texas Medical Center
Wroclaw, , Poland
Lukasz Matusiak 4health
Wroclaw, , Poland
dermMedica Sp. z o.o.
Wroclaw, , Poland
Local Institution - 0203
Wroclaw, , Poland
Azbuka Zdorovya Medical Center
Kazan', , Russia
Local Institution - 0172
Krasnodar, , Russia
Local Institution - 0140
Moscow, , Russia
Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov
Moscow, , Russia
State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary
Ryazan, , Russia
Clinic of Skin Diseases of Pierre Wolkenstein
Saint Petersburg, , Russia
Polyclinic of Private Security Personnel
Saint Petersburg, , Russia
Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology
Saint Petersburg, , Russia
Ars Vitae Multidisciplinary Medical Center
Saint Petersburg, , Russia
Klinika Kozhnykh I Venericheskikh Bolezney
Saratov, , Russia
Smolensk State Medical University
Smolensk, , Russia
MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
Yaroslavl, , Russia
Local Institution - 0131
Yekaterinburg, , Russia
Local Institution
Busan, , South Korea
Local Institution - 0187
Hwaseong-si, , South Korea
Local Institution
Hwaseong-si, , South Korea
Local Institution
Incheon, , South Korea
Local Institution
Seongnam-si, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution - 0121
Alcorcón, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital del Mar - Parc de Salut Mar
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario de Fuenlabrada
Madrid, , Spain
Local Institution - 0097
Valencia, , Spain
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
MAC Clinical Research - Blackpool
Lancashire, , United Kingdom
Synexus - Merseyside Clinical Research Centre
Liverpool, , United Kingdom
Guys and Saint Thomas NHS Foundation Trust
London, , United Kingdom
Synexus - Manchester Clinical Research Centre
Manchester, , United Kingdom
Salford Royal NHS Foundation Trust
Manchester, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
MAC Clinical Research - Liverpool
Prescot, , United Kingdom
Countries
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References
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Armstrong AW, Kircik L, Stein Gold L, Strober B, De Oliveira CHMC, Vaile J, Jou YM, Daamen C, Scharnitz T, Lebwohl M. Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials. Dermatol Ther (Heidelb). 2025 Apr;15(4):1025-1035. doi: 10.1007/s13555-025-01362-w. Epub 2025 Mar 20.
Morita A, Imafuku S, Tada Y, Okubo Y, Habiro K, Tsuritani K, Banerjee S, Hoyt K, Kisa RM, Ohtsuki M. Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 POETYK PSO-1, PSO-4, and LTE trials. J Dermatol. 2025 May;52(5):761-772. doi: 10.1111/1346-8138.17685. Epub 2025 Mar 11.
Armstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaci D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.
Armstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA. Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials. Dermatol Ther (Heidelb). 2024 Aug;14(8):2235-2248. doi: 10.1007/s13555-024-01224-x. Epub 2024 Jul 30.
Armstrong AW, Park SH, Patel V, Nicolas P, Wang WJ, Colombo MJ, Chirikov V. Cumulative Benefit Over 52 Weeks With Deucravacitinib Versus Apremilast in Moderate to Severe Plaque Psoriasis: POETYK PSO-1 Post Hoc Analysis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1891-1899. doi: 10.1007/s13555-024-01201-4. Epub 2024 Jun 22.
Armstrong AW, Gooderham M, Warren RB, Papp KA, Strober B, Thaci D, Morita A, Szepietowski JC, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary. Immunotherapy. 2023 Aug;15(12):963-973. doi: 10.2217/imt-2023-0061. Epub 2023 May 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2018-001926-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-046
Identifier Type: -
Identifier Source: org_study_id
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