Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis
NCT ID: NCT04036435
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1466 participants
INTERVENTIONAL
2019-08-12
2026-07-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMS-986165
BMS-986165
Specified dose on specified days
Vaccine Cohort
BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women must not be pregnant, lactating, or breastfeeding.
* Vaccine Cohort:
1. Subject must have moderate-to-severe plaque psoriasis, be currently receiving deucravacitinib treatment in the main IM011075 LTE cohort in the United States, Canada, or Poland, and must have completed at least one year of deucravacitinib treatment.
Exclusion Criteria
* To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.
* Vaccine Cohort:
1. Subject received the Pneumovax 23 vaccine ≤ 5 years before Day 1 or a pneumococcal conjugate vaccine ≤ 1 year before Day 1.
2. Subject received the Boostrix vaccine (as single or part of a combination vaccine) ≤ 5 years before Day 1.
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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Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States
Local Institution - 0278
Birmingham, Alabama, United States
Alliance Dermatology and Mohs Center - Phoenix
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Synexus - Orange Grove Family Practice
Tucson, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States
Local Institution - 0046
Fountain Valley, California, United States
Local Institution - 0206
Fresno, California, United States
Local Institution - 0017
Irvine, California, United States
Interspond - Long Beach Clinical Trials
Long Beach, California, United States
Dermatology Research Associates - Los Angeles
Los Angeles, California, United States
Local Institution - 0236
Los Angeles, California, United States
University of California San Diego Health Systems
San Diego, California, United States
Therapeutics Clinical Research
San Diego, California, United States
University Dermatology Group
San Diego, California, United States
Local Institution - 0094
San Luis Obispo, California, United States
Clinical Science Institute
Santa Monica, California, United States
NorthBay Clinical Research
Santa Rosa, California, United States
Synexus - Santa Rosa
Santa Rosa, California, United States
Local Institution - 0042
Sherman Oaks, California, United States
Care Access Research - Walnut Creek
Walnut Creek, California, United States
New England Research Associates
Bridgeport, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Local Institution - 0170
Boca Raton, Florida, United States
ERN - Accel Research Sites
DeLand, 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
Local Institution - 0216
Miami, Florida, United States
Interspond - Savin Medical Group
Miami Lakes, Florida, United States
Local Institution - 0007
Miami Lakes, Florida, United States
Local Institution - 0198
Port Orange, Florida, United States
Local Institution - 0233
Tampa, Florida, United States
Local Institution - 0008
Tampa, Florida, United States
Local Institution - 0013
Marietta, Georgia, United States
Local Institution - 0235
Sandy Springs, Georgia, United States
Treasure Valley Dermatology & Skin Cancer Center
Meridian, Idaho, United States
Springfield Clinic
Springfield, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
Clinical Research Advantage - Evansville - South Kenmore Drive
Evansville, Indiana, United States
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, United States
Local Institution - 0020
Plainfield, Indiana, United States
The South Bend Clinic
South Bend, Indiana, United States
Local Institution - 0040
Louisville, Kentucky, United States
Shondra L. Smith, M.D.
Lake Charles, Louisiana, United States
Clinical Trials of America - Monroe
Monroe, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Local Institution - 0291
Boston, Massachusetts, United States
Ora
Chestnut Hill, Massachusetts, United States
Local Institution - 0234
Methuen, Massachusetts, United States
DermCare Experts
Quincy, Massachusetts, United States
David Fivenson MD Dermatology
Ann Arbor, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Local Institution - 0025
Troy, Michigan, United States
Associated Skin Care Specialists - Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Washington University School of Medicine - West County Dermatology
St Louis, Missouri, United States
Clinical Research Consortium - Las Vegas
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Local Institution - 0016
East Windsor, New Jersey, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Local Institution - 0058
New York, New York, United States
Local Institution - 0218
Stony Brook, New York, United States
Montefiore Medical Center - Bronx
The Bronx, New York, United States
PMG Research of Cary
Cary, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Radiant Research - Columbus
Columbus, Ohio, United States
ClinOhio Research Services
Columbus, Ohio, United States
Local Institution - 0176
Fairborn, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Local Institution - 0167
Portland, Oregon, United States
Local Institution - 0009
Portland, Oregon, United States
Local Institution - 0045
Exton, Pennsylvania, United States
Local Institution - 0282
Pittsburgh, Pennsylvania, United States
Radiant Research - Anderson
Anderson, South Carolina, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Local Institution - 0037
Greer, South Carolina, United States
Coastal Carolina Research Center - Mount Pleasant
North Charleston, South Carolina, United States
Local Institution - 0004
Rapid City, South Dakota, United States
Rivergate Dermatology - Main Office
Goodlettsville, Tennessee, United States
Clinical Research Solutions - Jackson
Jackson, Tennessee, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
Local Institution - 0006
Arlington, Texas, United States
Bellaire Dermatology
Bellaire, Texas, United States
Local Institution - 0015
Dallas, Texas, United States
Local Institution - 0195
Dallas, Texas, United States
Local Institution - 0030
Dallas, Texas, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Center for Clinical Studies - Texas Medical Center
Houston, 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
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Interspond - Acclaim Dermatology
Sugar Land, Texas, United States
Interspond - Houston Center for Clinical Research
Sugar Land, Texas, United States
Center for Clinical Studies - Webster
Webster, Texas, United States
Local Institution - 0265
Seattle, Washington, United States
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Local Institution - 0246
Darlinghurst, New South Wales, Australia
St. George Dermatology & Skin Care Centre
Kogarah, New South Wales, Australia
Local Institution - 0250
Westmead, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Local Institution - 0241
Woolloongabba, Queensland, Australia
North Eastern Health Specialists
Hectorville, South Australia, Australia
Local Institution - 0245
Box Hill, Victoria, Australia
Skin and Cancer Foundation
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Local Institution - 0251
Parkville, Victoria, Australia
Local Institution - 0247
Perth, Western Australia, Australia
Beacon Dermatology
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
SkinFit MD Laser and Cosmetic Clinic
Surrey, British Columbia, Canada
Local Institution - 0152
Vancouver, British Columbia, Canada
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada
CCA Medical Research
Ajax, Ontario, Canada
Mediprobe Research
London, Ontario, Canada
Local Institution - 0090
London, Ontario, Canada
Lynderm Research
Markham, Ontario, Canada
DermEdge
Mississauga, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Office of Dr. Niakosari Firouzeh
North York, Ontario, Canada
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada
Local Institution - 0088
Peterborough, Ontario, Canada
Local Institution - 0082
Richmond Hill, Ontario, Canada
Toronto Dermatology Centre
Toronto, Ontario, Canada
Local Institution - 0132
Toronto, Ontario, Canada
Kim Papp Clinical Research
Waterloo, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Docteur David Gratton Dermatologue
Montreal, Quebec, Canada
Siena Medical Research
Montreal, Quebec, Canada
Local Institution - 0258
Québec, Quebec, Canada
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
Local Institution
Wuhan, Hubei, China
Local Institution
Wuhan, Hubei, China
Local Institution - 0312
Nanjing, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Dalian, Liaoning, China
Local Institution
Taiyuan, Shan1xi, China
Local Institution - 0292
Shanghai, Shanghai Municipality, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Nemocnice Jihlava
Jihlava, , Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín, , Czechia
Local Institution - 0163
Olomouc, , Czechia
Local Institution - 0165
Ostrava, , Czechia
Clintrial
Prague, , Czechia
Sanatorium profesora Arenbergera
Prague, , Czechia
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, , Czechia
Local Institution - 0279
Tampere, , Finland
Centre Hospitalier Universitaire de Nice Hopital lArchet
Nice, , France
Licca Clinical Research Institute
Augsburg, , Germany
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
Bochum, , Germany
Hautarztpraxis Dr. Beatrice Gerlach
Dresden, , Germany
Synexus Frankfurt Clinical Research
Frankfurt am Main, , Germany
Local Institution - 0263
Hamburg, , Germany
Dermakiel - Allergie Und Haut Centrum
Kiel, , Germany
Praxis Dr. Beate Schwarz
Langenau, , Germany
Praxis Dr. med. Wilfried Steinborn
Straubing, , Germany
CentroDerm Privatklinik
Wuppertal, , Germany
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest, , Hungary
Synexus Magyarorszag
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula
Gyula, , Hungary
Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
Nyíregyháza, , Hungary
Local Institution - 0151
Pécs, , Hungary
Allergo-Derm Bakos
Szolnok, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
Zalaegerszeg, , Hungary
Local Institution - 0237
Haifa, , Israel
Local Institution
Petah Tikva, , Israel
Local Institution
Ramat Gan, , Israel
Local Institution - 0065
Nagoya, Aichi-ken, Japan
Local Institution - 0069
Fukuoka, Fukuoka, Japan
Sapporo Skin Clinic
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Local Institution - 0075
Yokohama, Kanagawa, Japan
Local Institution - 0076
Nankoku, Kochi, Japan
Local Institution - 0066
Kyoto, Kyoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Local Institution - 0072
Matsumoto, Nagano, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Local Institution - 0061
Itabashi-Ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
The Jikei University Hospital
Minato-ku, Tokyo, Japan
Local Institution - 0062
Shinagawa, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Japan Community Health Care Organization Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, Japan
Local Institution - 0096
Kumamoto, , Japan
Local Institution - 0093
Kyoto, , Japan
Local Institution - 0073
Osaka, , Japan
Local Institution - 0067
Osaka, , Japan
Local Institution
Mount Cook, , New Zealand
Local Institution
Tauranga, , New Zealand
Local Institution - 0138
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0104
Bialystok, , Poland
ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, , Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok, , Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Local Institution - 0149
Gdansk, , Poland
Synexus Polska Oddzial w Gdyni
Gdynia, , Poland
Zespol Naukowo-Leczniczy Iwolang
Iwonicz-Zdrój, , Poland
Synexus - Katowice
Katowice, , Poland
Krakowskie Centrum Medyczne
Krakow, , Poland
Pratia MCM Krakow
Krak, , Poland
Centrum Terapii Wspolczesnej
Lodz, , Poland
Local Institution - 0114
Lodz, , Poland
Local Institution - 0144
Lodz, , Poland
Centrum Medyczne All-Med
Lodz, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER
Lublin, , Poland
Miejski Szpital Zespolony w Olsztynie
Olsztyn, , Poland
DermoDent - Centrum Medyczne Czajkowscy
Osielsko, , Poland
Local Institution - 0103
Poznan, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
ETG - Siedlce
Siedlce, , Poland
Local Institution - 0113
Skierniewice, , Poland
Local Institution - 0125
Torun, , Poland
Clinical Research Group
Warsaw, , Poland
High-Med Przychodnia Specjalistyczna
Warsaw, , Poland
Local Institution - 0119
Warsaw, , Poland
Local Institution - 0324
Warsaw, , Poland
Local Institution - 0111
Warsaw, , Poland
Local Institution - 0137
Wroc?aw, , Poland
dermMedica Sp. z o.o.
Wroclaw, , Poland
Local Institution - 0124
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Local Institution - 0289
San Juan, , Puerto Rico
Local Institution - 0172
Kazan', , Russia
Local Institution - 0187
Krasnodar, , Russia
Local Institution - 0171
Moscow, , Russia
Local Institution - 0175
Moscow, , Russia
Local Institution - 0169
Moscow, , Russia
Local Institution - 0190
Ryazan, , Russia
Local Institution - 0179
Saint Petersburg, , Russia
Local Institution - 0182
Saint Petersburg, , Russia
Local Institution - 0201
Saint Petersburg, , Russia
Local Institution - 0202
Saratov, , Russia
Local Institution - 0184
Smolensk, , Russia
Local Institution - 0222
Yaroslavl, , Russia
Local Institution - 0178
Yekaterinburg, , Russia
Local Institution - 0306
Seongnam-si, Gyeonggi-do, South Korea
Local Institution
Bucheon-si, , South Korea
Local Institution - 0054
Busan, , South Korea
Local Institution
Goyang-si, , South Korea
Local Institution - 0310
Gwangju, , South Korea
Local Institution
Hwaseong-si, , South Korea
Local Institution
Incheon, , South Korea
Local Institution
Incheon, , South Korea
Local Institution - 0051
Seongnam-si, , South Korea
Local Institution
Seoul, , South Korea
Local Institution - 0305
Seoul, , South Korea
Local Institution - 0055
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution - 0053
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Suwon, , South Korea
Local Institution - 0223
Alcorcón, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Local Institution - 0230
Barakaldo, , Spain
Local Institution - 0225
Córdoba, , Spain
Local Institution - 0226
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital de Manises
Manises, , Spain
Local Institution - 0227
Málaga, , Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, , Spain
Ladulaas Kliniska Studier
Borås, , Sweden
ProbarE i Lund
Lund, , Sweden
Local Institution - 0186
Solna, , Sweden
Local Institution - 0079
Kaohsiung City, , Taiwan
Local Institution - 0297
Kaohsiung City, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution - 0153
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
MAC Clinical Research - Cannock
Cannock, , United Kingdom
Synexus - Lancashire Clinical Research Centre
Chorley, , United Kingdom
Synexus - Manchester Clinical Research Centre
Chorley, , United Kingdom
Synexus - Merseyside Clinical Research Centre
Chorley, , United Kingdom
Mounts Bay Medical
Cornwall, , United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, , United Kingdom
Local Institution - 0212
Durham, , United Kingdom
MAC Clinical Research - Blackpool
Lancashire, , United Kingdom
Burbage Surgery
Leicestershire, , United Kingdom
Guys and Saint Thomas NHS Foundation Trust
London, , United Kingdom
MAC Clinical Research - Manchester
Manchester, , United Kingdom
Salford Royal NHS Foundation Trust
Manchester, , United Kingdom
Local Institution - 0209
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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2019-000612-29
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM011-075
Identifier Type: -
Identifier Source: org_study_id
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