AzTrials
AzTrials

PsoriasisPhase 3POETYK PSO-LTENCT04036435

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

A Phase 3 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 302 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
BMS-986165
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,466 participants
Where
302 sitesin 20 countries
Study dates
12 Aug 2019to 21 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • 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:
  • Subject received the Pneumovax 23 vaccine ≤ 5 years before Day 1 or a pneumococcal conjugate vaccine ≤ 1 year before Day 1.
  • 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

Trial locations and contacts

302 sites in 20 countries.

302 sites in 20 countries

United States101 sites

  • Radiant Research - Anderson

    Anderson, South Carolina, 29621

  • David Fivenson MD Dermatology

    Ann Arbor, Michigan, 48103

  • Local Institution - 0006

    Arlington, Texas, 76011

  • Bellaire Dermatology

    Bellaire, Texas, 77401

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Total Skin and Beauty Dermatology Center

    Birmingham, Alabama, 35205

  • Local Institution - 0278

    Birmingham, Alabama, 35233

  • Local Institution - 0170

    Boca Raton, Florida, 33486

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Local Institution - 0291

    Boston, Massachusetts, 02215

  • New England Research Associates

    Bridgeport, Connecticut, 06606

  • PMG Research of Cary

    Cary, North Carolina, 27615

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

  • Ora

    Chestnut Hill, Massachusetts, 02467

  • Radiant Research - Columbus

    Columbus, Ohio, 43212

  • ClinOhio Research Services

    Columbus, Ohio, 43213

  • Local Institution - 0015

    Dallas, Texas, 75230

  • Local Institution - 0195

    Dallas, Texas, 75231

  • Local Institution - 0030

    Dallas, Texas, 75234

  • Menter Dermatology Research Institute

    Dallas, Texas, 75246

  • ERN - Accel Research Sites

    DeLand, Florida, 32720

  • Local Institution - 0016

    East Windsor, New Jersey, 08520

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47708

  • Clinical Research Advantage - Evansville - South Kenmore Drive

    Evansville, Indiana, 47714

  • Local Institution - 0045

    Exton, Pennsylvania, 19341

  • Local Institution - 0176

    Fairborn, Ohio, 45324

  • Hamzavi Dermatology

    Fort Gratiot, Michigan, 48059

  • Johnson Dermatology

    Fort Smith, Arkansas, 72916

  • Local Institution - 0046

    Fountain Valley, California, 92708

  • Local Institution - 0206

    Fresno, California, 93720

  • Rivergate Dermatology - Main Office

    Goodlettsville, Tennessee, 37072

  • Local Institution - 0037

    Greer, South Carolina, 29651

  • Indago Research and Health Center

    Hialeah, Florida, 33012

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

  • Center for Clinical Studies - Texas Medical Center

    Houston, Texas, 77004

  • Dawes Fretzin Dermatology Group

    Indianapolis, Indiana, 46250

  • Local Institution - 0017

    Irvine, California, 92697

  • Clinical Research Solutions - Jackson

    Jackson, Tennessee, 38305

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11374

  • Dermatology Associates of Knoxville

    Knoxville, Tennessee, 37917

  • The Skin Wellness Center

    Knoxville, Tennessee, 37922

  • Shondra L. Smith, M.D.

    Lake Charles, Louisiana, 70605-1213

  • Clinical Research Consortium - Las Vegas

    Las Vegas, Nevada, 89119

  • Interspond - Long Beach Clinical Trials

    Long Beach, California, 90806

  • Dermatology Research Associates - Los Angeles

    Los Angeles, California, 90045-3606

  • Local Institution - 0236

    Los Angeles, California, 90057

  • Local Institution - 0040

    Louisville, Kentucky, 40217

  • Local Institution - 0013

    Marietta, Georgia, 30060

  • Treasure Valley Dermatology & Skin Cancer Center

    Meridian, Idaho, 83642

  • Local Institution - 0234

    Methuen, Massachusetts, 01844

  • LCC Medical Research

    Miami, Florida, 33126

  • International Dermatology Research

    Miami, Florida, 33144

  • Well Pharma Medical Research

    Miami, Florida, 33173

  • Local Institution - 0216

    Miami, Florida, 33176

  • Interspond - Savin Medical Group

    Miami Lakes, Florida, 33014

  • Local Institution - 0007

    Miami Lakes, Florida, 33014

  • Clinical Trials of America - Monroe

    Monroe, Louisiana, 71201

  • Associated Skin Care Specialists - Minnesota Clinical Study Center

    New Brighton, Minnesota, 55112

  • Local Institution - 0058

    New York, New York, 10028

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Coastal Carolina Research Center - Mount Pleasant

    North Charleston, South Carolina, 29405

  • Unity Clinical Research

    Oklahoma City, Oklahoma, 73118

  • Austin Institute for Clinical Research - Pflugerville

    Pflugerville, Texas, 78660

  • Alliance Dermatology and Mohs Center - Phoenix

    Phoenix, Arizona, 85032

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Local Institution - 0282

    Pittsburgh, Pennsylvania, 15213

  • Local Institution - 0020

    Plainfield, Indiana, 46168

  • Local Institution - 0198

    Port Orange, Florida, 32127

  • Local Institution - 0167

    Portland, Oregon, 97201

  • Local Institution - 0009

    Portland, Oregon, 97210

  • DermCare Experts

    Quincy, Massachusetts, 02169

  • Local Institution - 0004

    Rapid City, South Dakota, 57702

  • Northwest Arkansas Clinical Trials Center, PLLC

    Rogers, Arkansas, 72758

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78218

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229

  • University of California San Diego Health Systems

    San Diego, California, 92122

  • Therapeutics Clinical Research

    San Diego, California, 92123

  • University Dermatology Group

    San Diego, California, 92123

  • Local Institution - 0094

    San Luis Obispo, California, 93405

  • Local Institution - 0235

    Sandy Springs, Georgia, 30328

  • Clinical Science Institute

    Santa Monica, California, 90404

  • NorthBay Clinical Research

    Santa Rosa, California, 95405

  • Synexus - Santa Rosa

    Santa Rosa, California, 95405

  • Local Institution - 0265

    Seattle, Washington, 98101

  • Local Institution - 0042

    Sherman Oaks, California, 91403

  • The South Bend Clinic

    South Bend, Indiana, 46617

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Washington University School of Medicine - West County Dermatology

    St Louis, Missouri, 63141

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Local Institution - 0218

    Stony Brook, New York, 11790

  • Interspond - Acclaim Dermatology

    Sugar Land, Texas, 77479

  • Interspond - Houston Center for Clinical Research

    Sugar Land, Texas, 77479

  • Local Institution - 0233

    Tampa, Florida, 33609

  • Local Institution - 0008

    Tampa, Florida, 33614-7118

  • Montefiore Medical Center - Bronx

    The Bronx, New York, 10467

  • Local Institution - 0025

    Troy, Michigan, 48084

  • Synexus - Orange Grove Family Practice

    Tucson, Arizona, 85741

  • Care Access Research - Walnut Creek

    Walnut Creek, California, 94598

  • Center for Clinical Studies - Webster

    Webster, Texas, 77598

  • Dundee Dermatology

    West Dundee, Illinois, 60118

  • Wilmington Dermatology Center

    Wilmington, North Carolina, 28405

Other trials in United States

Poland32 sites

  • Local Institution - 0104

    Bialystok, 15-077

  • ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

    Bialystok, 15-351

  • ClinicMed Daniluk Nowak Spolka Jawna

    Bialystok, 15-879

  • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

    Elblag, 82-300

  • Local Institution - 0149

    Gdansk, 80-382

  • Synexus Polska Oddzial w Gdyni

    Gdynia, 81-537

  • Zespol Naukowo-Leczniczy Iwolang

    Iwonicz-Zdrój, 38-440

  • Synexus - Katowice

    Katowice, 40-040

  • Pratia MCM Krakow

    Krak, 30-510

  • Krakowskie Centrum Medyczne

    Krakow, 31-501

  • Centrum Terapii Wspolczesnej

    Lodz, 90-242

  • Local Institution - 0114

    Lodz, 90-265

  • Local Institution - 0144

    Lodz, 90-436

  • Centrum Medyczne All-Med

    Lodz, 94-048

  • Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

    Lublin, 20-406

  • Miejski Szpital Zespolony w Olsztynie

    Olsztyn, 10-229

  • DermoDent - Centrum Medyczne Czajkowscy

    Osielsko, 86-031

  • Local Institution - 0103

    Poznan, 60-446

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • ETG - Siedlce

    Siedlce, 08-110

  • Local Institution - 0113

    Skierniewice, 96-100

  • Local Institution - 0125

    Torun, 87-100

  • Local Institution - 0138

    Warsaw, Masovian Voivodeship, 02-962

  • Clinical Research Group

    Warsaw, 01-142

  • High-Med Przychodnia Specjalistyczna

    Warsaw, 01-817

  • Local Institution - 0119

    Warsaw, 02-793

  • Local Institution - 0324

    Warsaw, 02-793

  • Local Institution - 0111

    Warsaw, 02-953

  • Local Institution - 0137

    Wroc?aw, 50-566

  • dermMedica Sp. z o.o.

    Wroclaw, 51-318

  • Local Institution - 0124

    Wroclaw, 51-685

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

Japan24 sites

  • Local Institution - 0069

    Fukuoka, Fukuoka, 814-0180

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo, 173-8610

  • Local Institution - 0061

    Itabashi-Ku, Tokyo, 173-8606

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Local Institution - 0096

    Kumamoto, 860-8556

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 7108602

  • Local Institution - 0066

    Kyoto, Kyoto, 602-8566

  • Local Institution - 0093

    Kyoto, 606-8507

  • Local Institution - 0072

    Matsumoto, Nagano, 3908621

  • The Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Local Institution - 0065

    Nagoya, Aichi-ken, 467-8602

  • Local Institution - 0076

    Nankoku, Kochi, 783-8505

  • Local Institution - 0073

    Osaka, 5458586

  • Local Institution - 0067

    Osaka, 550-0006

  • Sapporo Skin Clinic

    Sapporo, Hokkaido, 060-0063

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

  • Local Institution - 0062

    Shinagawa, Tokyo, 141-8625

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 1600023

  • Japan Community Health Care Organization Tokyo Yamate Medical Center

    Shinjuku-ku, Tokyo, 169-0073

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

  • Local Institution - 0075

    Yokohama, Kanagawa, 245-8575

Other trials in Japan

Canada22 sites

  • CCA Medical Research

    Ajax, Ontario, L1S 7K8

  • Beacon Dermatology

    Calgary, Alberta, T3E 0B2

  • Stratica Medical

    Edmonton, Alberta, T5K 1X3

  • Mediprobe Research

    London, Ontario, N5X 2P1

  • Local Institution - 0090

    London, Ontario, N6H 5L5

  • Lynderm Research

    Markham, Ontario, L3P 1X2

  • DermEdge

    Mississauga, Ontario, L5H 1G9

  • Docteur David Gratton Dermatologue

    Montreal, Quebec, H3G 1A4

  • Siena Medical Research

    Montreal, Quebec, H3Z 2S6

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 3Z7

  • Office of Dr. Niakosari Firouzeh

    North York, Ontario, M2M 4J5

  • Institute of Cosmetic and Laser Surgery

    Oakville, Ontario, L6J 7W5

  • Local Institution - 0088

    Peterborough, Ontario, K9J 5K2

  • Local Institution - 0258

    Québec, Quebec, G1V 4X7

  • Local Institution - 0082

    Richmond Hill, Ontario, L4B 1A5

  • SkinFit MD Laser and Cosmetic Clinic

    Surrey, British Columbia, V3R 6A7

  • Toronto Dermatology Centre

    Toronto, Ontario, M3H 5Y8

  • Local Institution - 0132

    Toronto, Ontario, M4W 2N4

  • Local Institution - 0152

    Vancouver, British Columbia, V5Z 4E8

  • Kim Papp Clinical Research

    Waterloo, Ontario, N2J 1C4

  • XLR8 Medical Research

    Windsor, Ontario, N8W 1E6

  • Wiseman Dermatology Research

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

South Korea17 sites

  • Local Institution

    Bucheon-si, 14584

  • Local Institution - 0054

    Busan, 49201

  • Local Institution

    Goyang-si, 10380

  • Local Institution - 0310

    Gwangju, 61469

  • Local Institution

    Hwaseong-si, 18450

  • Local Institution

    Incheon, 21565

  • Local Institution

    Incheon, 22212

  • Local Institution - 0306

    Seongnam-si, Gyeonggi-do, 13496

  • Local Institution - 0051

    Seongnam-si, 13620

  • Local Institution

    Seoul, 02447

  • Local Institution - 0305

    Seoul, 03080

  • Local Institution - 0055

    Seoul, 03722

  • Local Institution

    Seoul, 05030

  • Local Institution

    Seoul, 08308

  • Local Institution - 0053

    Seoul, 137-701

  • Local Institution

    Seoul, 156-755

  • Local Institution

    Suwon, 16499

Other trials in South Korea

China15 sites

  • Local Institution

    Beijing, Beijing Municipality, 100050

  • Local Institution

    Beijing, Beijing Municipality, 100069

  • Local Institution

    Changchun, Jilin, 130021

  • Local Institution

    Chengdu, Sichuan, 610041

  • Local Institution

    Chongqing, Chongqing Municipality, 630014

  • Local Institution

    Dalian, Liaoning, 116011

  • Local Institution

    Hangzhou, Zhejiang, 310000

  • Local Institution

    Hangzhou, Zhejiang, 310003

  • Local Institution

    Hangzhou, Zhejiang, 310014

  • Local Institution

    Hangzhou, Zhejiang, 310016

  • Local Institution - 0312

    Nanjing, Jiangsu, 210029

  • Local Institution - 0292

    Shanghai, Shanghai Municipality, 200443

  • Local Institution

    Taiyuan, Shan1xi, 030001

  • Local Institution

    Wuhan, Hubei, 430022

  • Local Institution

    Wuhan, Hubei, 430030

Other trials in China

Russia13 sites

  • Local Institution - 0172

    Kazan', 420012

  • Local Institution - 0187

    Krasnodar, 350020

  • Local Institution - 0171

    Moscow, 101000

  • Local Institution - 0175

    Moscow, 111398

  • Local Institution - 0169

    Moscow, 123098

  • Local Institution - 0190

    Ryazan, 390046

  • Local Institution - 0179

    Saint Petersburg, 191123

  • Local Institution - 0182

    Saint Petersburg, 192007

  • Local Institution - 0201

    Saint Petersburg, 194021

  • Local Institution - 0202

    Saratov, 410028

  • Local Institution - 0184

    Smolensk, 214019

  • Local Institution - 0222

    Yaroslavl, 150003

  • Local Institution - 0178

    Yekaterinburg, 620076

Other trials in Russia

United Kingdom13 sites

  • MAC Clinical Research - Cannock

    Cannock, WS11 0BN

  • Synexus - Lancashire Clinical Research Centre

    Chorley, PR7 7NA

  • Synexus - Manchester Clinical Research Centre

    Chorley, PR7 7NA

  • Synexus - Merseyside Clinical Research Centre

    Chorley, PR7 7NA

  • Mounts Bay Medical

    Cornwall, TR27 5DT

  • The Dudley Group NHS Foundation Trust

    Dudley, DY1 2HQ

  • Local Institution - 0212

    Durham, TS17 6EW

  • MAC Clinical Research - Blackpool

    Lancashire, FY2 0JH

  • Burbage Surgery

    Leicestershire, LE10 2SE

  • Guys and Saint Thomas NHS Foundation Trust

    London, SE1 9RT

  • MAC Clinical Research - Manchester

    Manchester, M13 9NQ

  • Salford Royal NHS Foundation Trust

    Manchester, M6 8HD

  • Local Institution - 0209

    Prescot, L34 1BH

Other trials in United Kingdom

Australia12 sites

  • The Skin Centre

    Benowa, Queensland, 4217

  • Local Institution - 0245

    Box Hill, Victoria, 3128

  • Skin and Cancer Foundation

    Carlton, Victoria, 3053

  • Local Institution - 0246

    Darlinghurst, New South Wales, 2010

  • Sinclair Dermatology

    East Melbourne, Victoria, 3002

  • North Eastern Health Specialists

    Hectorville, South Australia, 5073

  • St. George Dermatology & Skin Care Centre

    Kogarah, New South Wales, 2217

  • Local Institution - 0251

    Parkville, Victoria, 3050

  • Local Institution - 0247

    Perth, Western Australia, 6160

  • Woden Dermatology

    Phillip, Australian Capital Territory, 2606

  • Local Institution - 0250

    Westmead, New South Wales, 2145

  • Local Institution - 0241

    Woolloongabba, Queensland, 4102

Other trials in Australia

Hungary10 sites

  • Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

    Budapest, 1036

  • Synexus Magyarorszag

    Budapest, 1036

  • Semmelweis Egyetem

    Budapest, 1085

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula

    Gyula, 5700

  • Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

    Nyíregyháza, 4400

  • Local Institution - 0151

    Pécs, 7632

  • Allergo-Derm Bakos

    Szolnok, 5000

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

    Zalaegerszeg, 8900

Other trials in Hungary

Germany9 sites

  • Licca Clinical Research Institute

    Augsburg, 86179

  • Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

    Bochum, 44793

  • Hautarztpraxis Dr. Beatrice Gerlach

    Dresden, 01097

  • Synexus Frankfurt Clinical Research

    Frankfurt am Main, 60313

  • Local Institution - 0263

    Hamburg, 20253

  • Dermakiel - Allergie Und Haut Centrum

    Kiel, 24148

  • Praxis Dr. Beate Schwarz

    Langenau, 89129

  • Praxis Dr. med. Wilfried Steinborn

    Straubing, 94315

  • CentroDerm Privatklinik

    Wuppertal, 42287

Other trials in Germany

Spain9 sites

  • Local Institution - 0223

    Alcorcón, 28921

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Local Institution - 0230

    Barakaldo, 48903

  • Local Institution - 0225

    Córdoba, 14004

  • Local Institution - 0226

    Las Palmas de Gran Canaria, 35010

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Local Institution - 0227

    Málaga, 29010

  • Hospital de Manises

    Manises, 46940

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

Czechia7 sites

  • Nemocnice Jihlava

    Jihlava, 586 01

  • Nemocnice Novy Jicin a.s.

    Nový Jičín, 741 01

  • Local Institution - 0163

    Olomouc, 779 00

  • Local Institution - 0165

    Ostrava, 708 52

  • Clintrial

    Prague, 100 00

  • Sanatorium profesora Arenbergera

    Prague, 110 00

  • Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

    Ústí nad Labem, 401 13

Other trials in Czechia

Taiwan7 sites

  • Local Institution - 0079

    Kaohsiung City, 81362

  • Local Institution - 0297

    Kaohsiung City, 83301

  • Local Institution

    Taipei, 100

  • Local Institution - 0153

    Taipei, 10449

  • Local Institution

    Taipei, 105

  • Local Institution

    Taipei, 11217

  • Local Institution

    Taipei, 114

Other trials in Taiwan

Israel3 sites

  • Local Institution - 0237

    Haifa, 3436212

  • Local Institution

    Petah Tikva, 49100

  • Local Institution

    Ramat Gan, 52621

Other trials in Israel

Sweden3 sites

  • Ladulaas Kliniska Studier

    Borås, 506 30

  • ProbarE i Lund

    Lund, 22222

  • Local Institution - 0186

    Solna, 171 76

Other trials in Sweden

New Zealand2 sites

  • Local Institution

    Mount Cook, 6021

  • Local Institution

    Tauranga, 3110

Other trials in New Zealand

Finland1 site

  • Local Institution - 0279

    Tampere, 33100

Other trials in Finland

France1 site

  • Centre Hospitalier Universitaire de Nice Hopital lArchet

    Nice, 06202

Other trials in France

Puerto Rico1 site

  • Local Institution - 0289

    San Juan, 917

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Psoriasis
Being tested
BMS-986165, Placebo
Keywords
Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986165Drug

    Also called Deucravacitinib

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

Study groups in NCT04036435
Study groupRoleWhat they receive
BMS-986165ExperimentalNot described
Receives: Drug: BMS-986165
Vaccine CohortExperimentalNot described
Receives: Drug: BMS-986165; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Measured: Up to 244 weeks

  2. Incidence of Serious Adverse Events (SAEs)

    Measured: Up to 244 weeks

  3. 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

    Measured: At Week 4 post vaccination

  4. 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

    Measured: At Week 4 post vaccination

Secondary outcomes (10)

  1. static Physician Global Assessment (sPGA) 0/1 response

    Measured: Up to 240 weeks

  2. Psoriasis Area and Severity Index (PASI) 75 response

    Measured: Up to 240 weeks

  3. Proportion of participants with anti-tetanus toxoid IgG geometric mean concentration (GMC) > 0.1 IU/mL

    Vaccine cohort only

    Measured: At Week 4 after vaccination

  4. Proportion of participants with IgG serologic response to the tetanus toxoid with ≥ 4-fold increase in antibody GMC

    Vaccine cohort only

    Measured: At Week 4 after vaccination

  5. Pneumococcal opsonophagocytic assay (OPA) geometric mean titers (GMTs)

    Vaccine cohort only

    Measured: At Week 4 after vaccination

  6. Pneumococcal OPA geometric mean fold rise (GMFRs)

    Vaccine cohort only

    Measured: At Week 4 after vaccination

  7. Incidence of treatment-emergent adverse events (TEAEs)

    Vaccine cohort only

    Measured: At Week 4 after vaccination

  8. Incidence of serious adverse events (SAEs)

    Vaccine cohort only

    Measured: At Week 4 after vaccination

  9. Incidence of AEs leading to discontinuation

    Vaccine cohort only

    Measured: At Week 4 after vaccination

  10. Incidence of vaccine-specific AEs

    Vaccine cohort only

    Measured: At Week 4 after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start12 Aug 2019
  3. Primary completion21 Jul 2026
  4. Study completion21 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04036435
Sponsor's protocol ID
IM011-075
Other IDs
2019-000612-29, 2019
Acronym
POETYK PSO-LTE
Status last verified
Aug 2026
First submitted
25 Jul 2019
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Publications

  • Armstrong AW, Lebwohl M, Warren RB, Morita A, Paul C, Thaci D, Augustin M, Puig L, Daamen C, Li J, Alio A, Aggrey-Amable A, Scotto J, Popmihajlov Z, Vaile J, Strober B. Deucravacitinib 5-Year Safety and Efficacy Results in Plaque Psoriasis: A Phase 3 Open-Label Extension of Randomized Clinical Trials. Am J Clin Dermatol. 2026 Aug 7. doi: 10.1007/s40257-026-01055-w. Online ahead of print.

    PubMed 42563042

  • 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.

    PubMed 40113724

  • 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.

    PubMed 40066907

  • 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.

    PubMed 39602111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 302 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 302 sites in United States, Poland, Japan, Canada, South Korea and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Up to 244 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04036435, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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