Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis (POETYK PSO-LTE)

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

The main purpose of this study is to evaluate the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in participants who have been previously enrolled in an applicable Phase 3 psoriasis study. In addition, the study includes a vaccine cohort to evaluate whether deucravacitinib impacts the humoral immune response to 2 non-live vaccines, the Pneumovax 23 vaccine (pneumococcus), a T-cell independent vaccine, and the Boostrix vaccine (tetanus toxoid), a T-cell dependent vaccine. Additionally, this vaccine cohort assesses the safety of administering these vaccines to subjects with psoriasis receiving deucravacitinib compared to those receiving a placebo.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: BMS-986165

• Study Type: Interventional
• Enrollment (Actual): 1466
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Local Institution - 0246
    • Kogarah, New South Wales, Australia, 2217
      • St. George Dermatology & Skin Care Centre
    • Westmead, New South Wales, Australia, 2145
      • Local Institution - 0250
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • Woolloongabba, Queensland, Australia, 4102
      • Local Institution - 0241
  • South Australia
    • Hectorville, South Australia, Australia, 5073
      • North Eastern Health Specialists
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Local Institution - 0245
    • Carlton, Victoria, Australia, 3053
      • Skin and Cancer Foundation
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Parkville, Victoria, Australia, 3050
      • Local Institution - 0251
  • Western Australia
    • Perth, Western Australia, Australia, 6160
      • Local Institution - 0247
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology
    • Edmonton, Alberta, Canada, T5K 1X3
      • Stratica Medical
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • SkinFit MD Laser and Cosmetic Clinic
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Local Institution - 0152
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research
    • London, Ontario, Canada, N5X 2P1
      • Mediprobe Research
    • London, Ontario, Canada, N6H 5L5
      • Local Institution - 0090
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research
    • Mississauga, Ontario, Canada, L5H 1G9
      • DermEdge
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • North York, Ontario, Canada, M2M 4J5
      • Office of Dr. Niakosari Firouzeh
    • Oakville, Ontario, Canada, L6J 7W5
      • Institute of Cosmetic and Laser Surgery
    • Peterborough, Ontario, Canada, K9J 5K2
      • Local Institution - 0088
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • Local Institution - 0082
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Dermatology Centre
    • Toronto, Ontario, Canada, M4W 2N4
      • Local Institution - 0132
    • Waterloo, Ontario, Canada, N2J 1C4
      • Kim Papp Clinical Research
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research
  • Quebec
    • Montreal, Quebec, Canada, H3Z 2S6
      • Siena Medical Research
    • Montreal, Quebec, Canada, H3G 1A4
      • Docteur David Gratton Dermatologue
    • Québec, Quebec, Canada, G1V 4X7
      • Local Institution - 0258
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Local Institution
    • Beijing, Beijing Municipality, China, 100069
      • Local Institution
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 630014
      • Local Institution
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Local Institution
    • Wuhan, Hubei, China, 430022
      • Local Institution
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Local Institution - 0312
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Local Institution
  • Shan1xi
    • Taiyuan, Shan1xi, China, 030001
      • Local Institution
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200443
      • Local Institution - 0292
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Local Institution
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution
    • Hangzhou, Zhejiang, China, 310014
      • Local Institution
• Czechia
  • Jihlava, Czechia, 586 01
    • Nemocnice Jihlava
  • Nový Jičín, Czechia, 741 01
    • Nemocnice Novy Jicin a.s.
  • Olomouc, Czechia, 779 00
    • Local Institution - 0163
  • Ostrava, Czechia, 708 52
    • Local Institution - 0165
  • Prague, Czechia, 110 00
    • Sanatorium Profesora Arenbergera
  • Prague, Czechia, 100 00
    • Clintrial
  • Ústí nad Labem, Czechia, 401 13
    • Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
• Finland
  • Tampere, Finland, 33100
    • Local Institution - 0279
• France
  • Nice, France, 06202
    • Centre Hospitalier Universitaire de Nice Hopital lArchet
• Germany
  • Augsburg, Germany, 86179
    • Licca Clinical Research Institute
  • Bochum, Germany, 44793
    • Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
  • Dresden, Germany, 01097
    • Hautarztpraxis Dr. Beatrice Gerlach
  • Frankfurt am Main, Germany, 60313
    • Synexus Frankfurt Clinical Research
  • Hamburg, Germany, 20253
    • Local Institution - 0263
  • Kiel, Germany, 24148
    • DermaKiel - Allergie und Haut Centrum
  • Langenau, Germany, 89129
    • Praxis Dr. Beate Schwarz
  • Straubing, Germany, 94315
    • Praxis Dr. med. Wilfried Steinborn
  • Wuppertal, Germany, 42287
    • CentroDerm Privatklinik
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag
  • Budapest, Hungary, 1036
    • Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4025
    • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
  • Gyula, Hungary, 5700
    • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula
  • Nyíregyháza, Hungary, 4400
    • Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
  • Pécs, Hungary, 7632
    • Local Institution - 0151
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos
  • Zalaegerszeg, Hungary, 8900
    • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
• Israel
  • Haifa, Israel, 3436212
    • Local Institution - 0237
  • Petah Tikva, Israel, 49100
    • Local Institution
  • Ramat Gan, Israel, 52621
    • Local Institution
• Japan
  • Kumamoto, Japan, 860-8556
    • Local Institution - 0096
  • Kyoto, Japan, 606-8507
    • Local Institution - 0093
  • Osaka, Japan, 550-0006
    • Local Institution - 0067
  • Osaka, Japan, 5458586
    • Local Institution - 0073
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Local Institution - 0065
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 814-0180
      • Local Institution - 0069
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0063
      • Sapporo Skin Clinic
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Kobe University Hospital
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
    • Yokohama, Kanagawa, Japan, 245-8575
      • Local Institution - 0075
  • Kochi
    • Nankoku, Kochi, Japan, 783-8505
      • Local Institution - 0076
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • Local Institution - 0066
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Mie University Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 3908621
      • Local Institution - 0072
  • Okayama-ken
    • Kurashiki, Okayama-ken, Japan, 7108602
      • Kurashiki Central Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Itabashi-Ku, Tokyo, Japan, 173-8606
      • Local Institution - 0061
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital
    • Shinagawa, Tokyo, Japan, 141-8625
      • Local Institution - 0062
    • Shinjuku-ku, Tokyo, Japan, 1600023
      • Tokyo Medical University Hospital
    • Shinjuku-ku, Tokyo, Japan, 169-0073
      • Japan Community Health Care Organization Tokyo Yamate Medical Center
• New Zealand
  • Mount Cook, New Zealand, 6021
    • Local Institution
  • Tauranga, New Zealand, 3110
    • Local Institution
• Poland
  • Bialystok, Poland, 15-351
    • ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
  • Bialystok, Poland, 15-879
    • ClinicMed Daniluk Nowak Spolka Jawna
  • Bialystok, Poland, 15-077
    • Local Institution - 0104
  • Elblag, Poland, 82-300
    • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
  • Gdansk, Poland, 80-382
    • Local Institution - 0149
  • Gdynia, Poland, 81-537
    • Synexus Polska Oddzial w Gdyni
  • Iwonicz-Zdrój, Poland, 38-440
    • Zespol Naukowo-Leczniczy Iwolang
  • Katowice, Poland, 40-040
    • Synexus - Katowice
  • Krak, Poland, 30-510
    • Pratia MCM Krakow
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne
  • Lodz, Poland, 90-242
    • Centrum Terapii Wspolczesnej
  • Lodz, Poland, 94-048
    • Centrum Medyczne ALL-MED
  • Lodz, Poland, 90-265
    • Local Institution - 0114
  • Lodz, Poland, 90-436
    • Local Institution - 0144
  • Lublin, Poland, 20-406
    • Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser
  • Olsztyn, Poland, 10-229
    • Miejski Szpital Zespolony w Olsztynie
  • Osielsko, Poland, 86-031
    • DermoDent - Centrum Medyczne Czajkowscy
  • Poznan, Poland, 60-529
    • Solumed Centrum Medyczne
  • Poznan, Poland, 60-446
    • Local Institution - 0103
  • Siedlce, Poland, 08-110
    • ETG - Siedlce
  • Skierniewice, Poland, 96-100
    • Local Institution - 0113
  • Torun, Poland, 87-100
    • Local Institution - 0125
  • Warsaw, Poland, 01-817
    • High-Med Przychodnia Specjalistyczna
  • Warsaw, Poland, 02-953
    • Local Institution - 0111
  • Warsaw, Poland, 01-142
    • Clinical Research Group
  • Warsaw, Poland, 02-793
    • Local Institution - 0119
  • Warsaw, Poland, 02-793
    • Local Institution - 0324
  • Wroc?aw, Poland, 50-566
    • Local Institution - 0137
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Wroclaw, Poland, 51-318
    • dermMedica Sp. z o.o.
  • Wroclaw, Poland, 51-685
    • Local Institution - 0124
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-962
      • Local Institution - 0138
• Puerto Rico
  • San Juan, Puerto Rico, 917
    • Local Institution - 0289
• Russia
  • Kazan', Russia, 420012
    • Local Institution - 0172
  • Krasnodar, Russia, 350020
    • Local Institution - 0187
  • Moscow, Russia, 101000
    • Local Institution - 0171
  • Moscow, Russia, 111398
    • Local Institution - 0175
  • Moscow, Russia, 123098
    • Local Institution - 0169
  • Ryazan, Russia, 390046
    • Local Institution - 0190
  • Saint Petersburg, Russia, 191123
    • Local Institution - 0179
  • Saint Petersburg, Russia, 192007
    • Local Institution - 0182
  • Saint Petersburg, Russia, 194021
    • Local Institution - 0201
  • Saratov, Russia, 410028
    • Local Institution - 0202
  • Smolensk, Russia, 214019
    • Local Institution - 0184
  • Yaroslavl, Russia, 150003
    • Local Institution - 0222
  • Yekaterinburg, Russia, 620076
    • Local Institution - 0178
• South Korea
  • Bucheon-si, South Korea, 14584
    • Local Institution
  • Busan, South Korea, 49201
    • Local Institution - 0054
  • Goyang-si, South Korea, 10380
    • Local Institution
  • Gwangju, South Korea, 61469
    • Local Institution - 0310
  • Hwaseong-si, South Korea, 18450
    • Local Institution
  • Incheon, South Korea, 21565
    • Local Institution
  • Incheon, South Korea, 22212
    • Local Institution
  • Seongnam-si, South Korea, 13620
    • Local Institution - 0051
  • Seoul, South Korea, 02447
    • Local Institution
  • Seoul, South Korea, 03080
    • Local Institution - 0305
  • Seoul, South Korea, 03722
    • Local Institution - 0055
  • Seoul, South Korea, 05030
    • Local Institution
  • Seoul, South Korea, 08308
    • Local Institution
  • Seoul, South Korea, 137-701
    • Local Institution - 0053
  • Seoul, South Korea, 156-755
    • Local Institution
  • Suwon, South Korea, 16499
    • Local Institution
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13496
      • Local Institution - 0306
• Spain
  • Alcorcón, Spain, 28921
    • Local Institution - 0223
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Barakaldo, Spain, 48903
    • Local Institution - 0230
  • Córdoba, Spain, 14004
    • Local Institution - 0225
  • Las Palmas de Gran Canaria, Spain, 35010
    • Local Institution - 0226
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Manises, Spain, 46940
    • Hospital de Manises
  • Málaga, Spain, 29010
    • Local Institution - 0227
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Universitario Quironsalud Madrid
• Sweden
  • Borås, Sweden, 506 30
    • Ladulaas Kliniska Studier
  • Lund, Sweden, 22222
    • ProbarE i Lund
  • Solna, Sweden, 171 76
    • Local Institution - 0186
• Taiwan
  • Kaohsiung City, Taiwan, 81362
    • Local Institution - 0079
  • Kaohsiung City, Taiwan, 83301
    • Local Institution - 0297
  • Taipei, Taiwan, 100
    • Local Institution
  • Taipei, Taiwan, 105
    • Local Institution
  • Taipei, Taiwan, 11217
    • Local Institution
  • Taipei, Taiwan, 10449
    • Local Institution - 0153
  • Taipei, Taiwan, 114
    • Local Institution
• United Kingdom
  • Cannock, United Kingdom, WS11 0BN
    • MAC Clinical Research - Cannock
  • Chorley, United Kingdom, PR7 7NA
    • Synexus - Lancashire Clinical Research Centre
  • Chorley, United Kingdom, PR7 7NA
    • Synexus - Manchester Clinical Research Centre
  • Chorley, United Kingdom, PR7 7NA
    • Synexus - Merseyside Clinical Research Centre
  • Cornwall, United Kingdom, TR27 5DT
    • Mounts Bay Medical
  • Dudley, United Kingdom, DY1 2HQ
    • The Dudley Group NHS Foundation Trust
  • Durham, United Kingdom, TS17 6EW
    • Local Institution - 0212
  • Lancashire, United Kingdom, FY2 0JH
    • MAC Clinical Research - Blackpool
  • Leicestershire, United Kingdom, LE10 2SE
    • Burbage Surgery
  • London, United Kingdom, SE1 9RT
    • Guys and Saint Thomas NHS Foundation Trust
  • Manchester, United Kingdom, M6 8HD
    • Salford Royal NHS Foundation Trust
  • Manchester, United Kingdom, M13 9NQ
    • MAC Clinical Research - Manchester
  • Prescot, United Kingdom, L34 1BH
    • Local Institution - 0209
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin And Beauty Dermatology Center
    • Birmingham, Alabama, United States, 35233
      • Local Institution - 0278
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center - Phoenix
    • Tucson, Arizona, United States, 85741
      • Synexus - Orange Grove Family Practice
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center, PLLC
  • California
    • Fountain Valley, California, United States, 92708
      • Local Institution - 0046
    • Fresno, California, United States, 93720
      • Local Institution - 0206
    • Irvine, California, United States, 92697
      • Local Institution - 0017
    • Long Beach, California, United States, 90806
      • Interspond - Long Beach Clinical Trials
    • Los Angeles, California, United States, 90045-3606
      • Dermatology Research Associates - Los Angeles
    • Los Angeles, California, United States, 90057
      • Local Institution - 0236
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • San Diego, California, United States, 92123
      • University Dermatology Group
    • San Diego, California, United States, 92122
      • University of California San Diego Health Systems
    • San Luis Obispo, California, United States, 93405
      • Local Institution - 0094
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Santa Rosa, California, United States, 95405
      • Synexus - Santa Rosa
    • Santa Rosa, California, United States, 95405
      • NorthBay Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Local Institution - 0042
    • Walnut Creek, California, United States, 94598
      • Care Access Research - Walnut Creek
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Local Institution - 0170
    • DeLand, Florida, United States, 32720
      • ERN - Accel Research Sites
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center
    • Miami, Florida, United States, 33144
      • International Dermatology Research
    • Miami, Florida, United States, 33126
      • LCC Medical Research
    • Miami, Florida, United States, 33173
      • Well Pharma Medical Research
    • Miami, Florida, United States, 33176
      • Local Institution - 0216
    • Miami Lakes, Florida, United States, 33014
      • Interspond - Savin Medical Group
    • Miami Lakes, Florida, United States, 33014
      • Local Institution - 0007
    • Port Orange, Florida, United States, 32127
      • Local Institution - 0198
    • Tampa, Florida, United States, 33609
      • Local Institution - 0233
    • Tampa, Florida, United States, 33614-7118
      • Local Institution - 0008
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Local Institution - 0013
    • Sandy Springs, Georgia, United States, 30328
      • Local Institution - 0235
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Treasure Valley Dermatology & Skin Cancer Center
  • Illinois
    • Springfield, Illinois, United States, 62703
      • Springfield Clinic
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Evansville, Indiana, United States, 47708
      • Deaconess Clinic Downtown
    • Evansville, Indiana, United States, 47714
      • Clinical Research Advantage - Evansville - South Kenmore Drive
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Dermatology Group
    • Plainfield, Indiana, United States, 46168
      • Local Institution - 0020
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Local Institution - 0040
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605-1213
      • Shondra L. Smith, M.D.
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of America - Monroe
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0291
    • Chestnut Hill, Massachusetts, United States, 02467
      • Ora
    • Methuen, Massachusetts, United States, 01844
      • Local Institution - 0234
    • Quincy, Massachusetts, United States, 02169
      • DermCare Experts
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson MD Dermatology
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Local Institution - 0025
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Associated Skin Care Specialists - Minnesota Clinical Study Center
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Washington University School of Medicine - West County Dermatology
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium - Las Vegas
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • East Windsor, New Jersey, United States, 08520
      • Local Institution - 0016
  • New York
    • Kew Gardens, New York, United States, 11374
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10028
      • Local Institution - 0058
    • Stony Brook, New York, United States, 11790
      • Local Institution - 0218
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center - Bronx
  • North Carolina
    • Cary, North Carolina, United States, 27615
      • PMG Research of Cary
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
  • Ohio
    • Columbus, Ohio, United States, 43213
      • ClinOhio Research Services
    • Columbus, Ohio, United States, 43212
      • Radiant Research - Columbus
    • Fairborn, Ohio, United States, 45324
      • Local Institution - 0176
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Local Institution - 0009
    • Portland, Oregon, United States, 97201
      • Local Institution - 0167
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Local Institution - 0045
    • Pittsburgh, Pennsylvania, United States, 15213
      • Local Institution - 0282
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research - Anderson
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
    • Greer, South Carolina, United States, 29651
      • Local Institution - 0037
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center - Mount Pleasant
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Local Institution - 0004
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology - Main Office
    • Jackson, Tennessee, United States, 38305
      • Clinical Research Solutions - Jackson
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
    • Knoxville, Tennessee, United States, 37917
      • Dermatology Associates of Knoxville
  • Texas
    • Arlington, Texas, United States, 76011
      • Local Institution - 0006
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Research Institute
    • Dallas, Texas, United States, 75231
      • Local Institution - 0195
    • Dallas, Texas, United States, 75230
      • Local Institution - 0015
    • Dallas, Texas, United States, 75234
      • Local Institution - 0030
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies - Texas Medical Center
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research - Pflugerville
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78218
      • University of Texas Health Science Center at San Antonio
    • Sugar Land, Texas, United States, 77479
      • Interspond - Acclaim Dermatology
    • Sugar Land, Texas, United States, 77479
      • Interspond - Houston Center for Clinical Research
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies - Webster
  • Washington
    • Seattle, Washington, United States, 98101
      • Local Institution - 0265

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis.
• 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

• Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.
• 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.
• Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986165	Drug: BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Vaccine Cohort	Drug: Placebo; Specified dose on specified days; Drug: BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)		Up to 244 weeks
Incidence of Serious Adverse Events (SAEs)		Up to 244 weeks
Proportion of participants achieving a satisfactory humoral response: pneumococcus	Vaccine cohort only Defined as ≥ 2-fold increase in immunoglobulin (IgG) antibody titers or geometric mean fold rise (GMFRs) titers of ≥ 6	At Week 4 post vaccination
Proportion of participants achieving a satisfactory humoral response: tetanus titers	Vaccine cohort only A serologic response is defined as: Postvaccination titer levels ≥ 0.40 IU/mL if prevaccination IgG antibody titer level is ≤ 0.10 IU/mL OR; Postvaccination titer levels of at least a 4-fold increase if prevaccination titer level is > 0.10 IU/mL and ≤ 2.7 IU/mL OR; Postvaccination titer levels of at least a 2-fold increase if prevaccination titer level is > 2.7 IU/mL	At Week 4 post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
static Physician Global Assessment (sPGA) 0/1 response		Up to 240 weeks
Psoriasis Area and Severity Index (PASI) 75 response		Up to 240 weeks
Proportion of participants with anti-tetanus toxoid IgG geometric mean concentration (GMC) > 0.1 IU/mL	Vaccine cohort only	At Week 4 after vaccination
Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC	Vaccine cohort only	At Week 4 after vaccination
Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)	Vaccine cohort only	At Week 4 after vaccination
Pneumococcal OPA geometric mean fold rise (GMFRs)	Vaccine cohort only	At Week 4 after vaccination
Incidence of treatment-emergent adverse events (TEAEs)	Vaccine cohort only	At Week 4 after vaccination
Incidence of serious adverse events (SAEs)	Vaccine cohort only	At Week 4 after vaccination
Incidence of AEs leading to discontinuation	Vaccine cohort only	At Week 4 after vaccination
Incidence of vaccine-specific AEs	Vaccine cohort only	At Week 4 after vaccination

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): July 26, 2026

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; deucravacitinib
• Other Study ID Numbers: IM011-075; 2019-000612-29 (Registry Identifier: EudraCT)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No