AzTrials
AzTrials

Plaque PsoriasisPhase 3POETYK-PsO-PedNCT06979453

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

A Phase 3 study testing Deucravacitinib in people with Plaque Psoriasis, run by Bristol-Myers Squibb at 133 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Deucravacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
133 sitesin 16 countries
Study dates
3 Dec 2025to 12 Aug 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
  • Participants must have moderate to severe psoriasis defined by:.
  • Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.
  • Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.
  • Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.
  • A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
  • Is not an individual of childbearing potential (IOCBP).
  • Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.

Who cannot join

  • Participants must not weigh < 30.0 kg at Screening and Day 1.
  • Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1.
  • Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1.
  • Participants must not have any untreated bacterial infection within 60 days prior to Day 1.
  • Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).
  • Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.
Show all 13Show fewer
  • Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention.
  • Participants must not have had any prior exposure to deucravacitinib.
  • Participants must not have received any medication that is specifically prohibited.
  • Participants must not have a laboratory finding that is exclusionary.
  • Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.
  • Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

133 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

133 sites in 16 countries

United States47 sites, 42 recruiting

  • Local Institution - 0271

    Ammon, Idaho, 83406

    Site 0271

    Not yet recruiting

  • Dermatology Affiliates Research Institute

    Atlanta, Georgia, 30305

    Adebayo Akinsola, Site 0244, 770-733-1077

    Recruiting

  • Local Institution - 0261

    Birmingham, Alabama, 35203

    Site 0261

    Not yet recruiting

  • Local Institution - 0041

    Birmingham, Alabama, 35243

    Withdrawn

  • Apex Clinical Research Center - Canton

    Canton, Ohio, 44716

    Jorge Garcia-Zuazaga, Site 0251, 14404404430440

    Recruiting

  • Local Institution - 0021

    Clearwater, Florida, 33756

    Site 0021

    Not yet recruiting

  • Local Institution - 0283

    Clifton, New Jersey, 07013

    Site 0283

    Not yet recruiting

  • Local Institution - 0233

    Columbia, Missouri, 65201

    Site 0233

    Not yet recruiting

  • Local Institution - 0278

    Columbia, Missouri, 65212

    Site 0278

    Not yet recruiting

  • C.S. Mott Clinical Research Center (CRC)

    Detroit, Michigan, 48201

    Geoffrey Potts, Site 0095, 248-581-5243

    Recruiting

  • Henry Ford Medical Center

    Detroit, Michigan, 48202-3141

    Linda Stein Gold, Site 0065, 248-884-5356

    Recruiting

  • Local Institution - 0025

    Fountain Valley, California, 92708

    Site 0025

    Not yet recruiting

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California, 94538

    Sunil Dhawan, Site 0090, 510-599-4750

    Recruiting

  • ObjectiveHealth - Goodlettsville Dermatology Research

    Goodlettsville, Tennessee, 37072

    Keith Loven, Site 0235, 615-241-2820

    Recruiting

  • Local Institution - 0234

    Hickory, North Carolina, 28602

    Completed

  • Local Institution - 0287

    Houston, Texas, 77030

    Site 0287

    Not yet recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

    Scott Fretzin, Site 0003, 317-516-5030

    Recruiting

  • JDR Dermatology Research

    Las Vegas, Nevada, 89148

    James Del Rosso, Site 0052, 702-596-6137

    Recruiting

  • Dermatology and Skin Cancer Center

    Lee's Summit, Missouri, 64064

    Mark Fleischman, Site 0266, 913-451-7546

    Recruiting

  • Apex Clinical Research Center

    Lorain, Ohio, 44053

    Garcia-Zuazaga Jorge, Site 0275

    Recruiting

  • Dermatology Research Associates

    Los Angeles, California, 90045

    Howard Sofen, Site 0006, 310-337-7171

    Recruiting

  • Life Clinical Trials

    Margate, Florida, 33063

    Eli Saleeby, Site 0185, 954-849-0902

    Recruiting

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124

    Brian Moore, Site 0055, 440-940-2739

    Recruiting

  • Local Institution - 0202

    Metairie, Louisiana, 70001

    Site 0202

    Not yet recruiting

  • Skin Research of South Florida

    Miami, Florida, 33173

    Giovanna Ciocca, Site 0043, 305-707-9852

    Recruiting

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

    David Rodriguez, Site 0014, 786-483-7856

    Recruiting

  • Kuchnir Dermatology & Dermatologic Surgery

    Milford, Massachusetts, 01757

    Shiu-Chung Au, Site 0220, 000-000-0000

    Recruiting

  • Frontier Derm Partners

    Mill Creek, Washington, 98012

    Eingun Song, Site 0071, 425-275-4404

    Recruiting

  • Kentucky Advanced Medical Research LLC

    Murray, Kentucky, 42071

    Hollis Clark, Site 0262

    Recruiting

  • Local Institution - 0248

    Nashville, Tennessee, 37205

    Completed

  • Local Institution - 0205

    New York, New York, 10075

    Site 0205

    Not yet recruiting

  • Local Institution - 0045

    Norfolk, Virginia, 23502

    Site 0045

    Not yet recruiting

  • Local Institution - 0214

    Northridge, California, 91325

    Active, not recruiting

  • Paddington Testing Company

    Philadelphia, Pennsylvania, 19103

    Jennifer Parish, Site 0073, 215-563-7330

    Recruiting

  • Local Institution - 0053

    Phoenix, Arizona, 85006

    Withdrawn

  • Aura Dermatology

    Robbinsville, New Jersey, 08691

    Darshan Vaidya, Site 0281

    Recruiting

  • Dermatology and Skin Cancer Specialists, LLC

    Rockville, Maryland, 20850

    Benjamin Lockshin, Site 0061, 301-355-3183

    Recruiting

  • Local Institution - 0077

    Sacramento, California, 95814

    Site 0077

    Not yet recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

    John Browning, Site 0033, 210-704-4037

    Recruiting

  • Advanced Medical Research, PC.

    Sandy Springs, Georgia, 30328

    Jamie Weisman, Site 0072, 404-939-9220

    Recruiting

  • Local Institution - 0280

    Southlake, Texas, 76092

    Site 0280

    Not yet recruiting

  • Local Institution - 0264

    Spokane, Washington, 99204

    Site 0264

    Not yet recruiting

  • MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research

    Tampa, Florida, 33607

    Stephen Lockwood, Site 0070, 813-948-7550

    Recruiting

  • USF Health

    Tampa, Florida, 33612

    Sharon Albers, Site 0171, 813-974-4381

    Recruiting

  • Local Institution - 0166

    The Bronx, New York, 10467

    Site 0166

    Not yet recruiting

  • Golden State Dermatology - Walnut Creek - Ygnacio Valley Road

    Walnut Creek, California, 94598

    Michael Wang, Site 0243, 507-261-3758

    Recruiting

  • Paradigm Clinical Research, LLC

    Wheat Ridge, Colorado, 80033

    Kimberly Neyman, Site 0231, 303-463-1947

    Recruiting

Other trials in United States

China11 sites, 11 recruiting

  • Beijing Children's hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

    Zigang Xu, Site 0134, 13370115021

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100091

    Wenhui Wang, Site 0222, 18618269437

    Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan, 410007

    Zhu Wei, Site 0148, 073185356114

    Recruiting

  • Local Institution - 0228

    Chengdu, Sichuan, 610091

    Site 0228

    Not yet recruiting

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong, 510018

    Zhimiao Lin, Site 0128, 13681438841

    Recruiting

  • The Affiliated Hospital of Hebei University of Engineering

    Handan, Hebei, 56029

    Guoying Miao, Site 0255, 0310-3962009

    Recruiting

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310006

    Liming Wu, Site 0224, 13750837205

    Recruiting

  • Shandong Provincial Dermatology Hospital and Shandong Institute of Dermatology and Venereology

    Jinan, Shandong, 250022

    furen Zhang, Site 0265, 13608921718

    Recruiting

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200443

    Yangfeng Ding, Site 0131, +86 18017336636

    Recruiting

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

    zhenying zhang, Site 0226, 13923848084

    Recruiting

  • People's Hospital of Henan Province

    Zhengzhou, Henan, 450003

    hongwei liu, Site 0227, 18637110289

    Recruiting

Other trials in China

Canada8 sites, 8 recruiting

  • Alberta Dermasurgery Centre

    Edmonton, Alberta, T6G 1C3

    Jaggi Rao, Site 0241, 587-487-0187

    Recruiting

  • DermEffects

    London, Ontario, N6H 5L5

    Wei Jing Loo, Site 0143, 2269197887

    Recruiting

  • Local Institution - 0142

    Montreal, Quebec, H3T 1C5

    Site 0142

    Not yet recruiting

  • The Centre for Dermatology

    Richmond Hill, Ontario, L4B 1A5

    Mani Raman, Site 0144, 905-889-2005

    Recruiting

  • Skincare Studio

    St. John's, Newfoundland and Labrador, A1E 1V4

    Tracey Brown-Maher, Site 0242, 709-728-1563

    Recruiting

  • AvantDerm

    Toronto, Ontario, M5A 3R6

    Davindra Singh, Site 0156, (416) 869-3376

    Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Rebecca Levy, Site 0240, +1 416-813-7835

    Recruiting

  • Local Institution - 0164

    Winnipeg, Manitoba, R3C 0N2

    Site 0164

    Not yet recruiting

Other trials in Canada

Poland8 sites, 7 recruiting

  • SPECDERM Poznanska sp.j.

    Bialystok, Podlaskie Voivodeship, 15-375

    Maria Poznanska, Site 0103, 0048883251755

    Recruiting

  • Local Institution - 0282

    Gdansk, Pomeranian Voivodeship, 80-546

    Site 0282

    Not yet recruiting

  • "DERMED" Centrum Medyczne Sp. z o.o.

    Lodz, 90-265

    Andrzej Kaszuba, Site 0106, 0048603544222

    Recruiting

  • Local Institution - 0177

    Lublin, Lublin Voivodeship, 20-573

    Withdrawn

  • ETYKA Osrodek Badan Klinicznych

    Olsztyn, 10-117

    Agata Maciejewska - Radomska, Site 0101, +48895134629

    Recruiting

  • FutureMeds - Targowek

    Warsaw, Masovian Voivodeship, 03-291

    Patrycja Wislinska, Site 0212, 48722266055

    Recruiting

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953

    Monika Kalowska, Site 0178, +48601986646

    Recruiting

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-962

    Witold Owczarek, Site 0102, 00 48 601 316 460

    Recruiting

Other trials in Poland

Romania8 sites, 6 recruiting

  • Local Institution - 0174

    Bucharest, Bucharest, 020125

    Withdrawn

  • Lotus-Med Tunari

    Bucharest, Bucharest, 020528

    Adelina-Maria Sendrea, Site 0249, 0040760930352

    Recruiting

  • Local Institution - 0285

    Bucharest, Bucharest, 030463

    Site 0285

    Not yet recruiting

  • Local Institution - 0213

    Bucharest, Bucharest, 30463

    Withdrawn

  • Local Institution - 0286

    Cluj-Napoca, 400006

    Site 0286

    Not yet recruiting

  • Policlinica Providența

    Iași, 700259

    Elena Crihan, Site 0181, 0040746743561

    Recruiting

  • Centrul de Medicina de Familie

    Iași, 700556

    Petronela Cozma, Site 0173, 0743813380

    Recruiting

  • New Derm Clinical SRL

    Timișoara, 300757

    Stefania Avram, Site 0200, 40752976613

    Recruiting

Other trials in Romania

Argentina7 sites, 7 recruiting

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012

    Pablo Gonzalez, Site 0149, +5491154140381

    Recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, 1181

    Maria Angles, Site 0221, +5491168360026

    Recruiting

  • Hospital de Niños Dr. Ricardo Gutiérrez

    Buenos Aires, 1425

    Ianina Massimo, Site 0250, 0054115236-4056

    Recruiting

  • Derma Internacional

    Buenos Aires, 1426

    Maria Laura Galimberti, Site 0154, 5491154583202

    Recruiting

  • Instituto de Neumonologia Y Dermatologia

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425

    Paula Carolina Luna, Site 0115, 1545404644

    Recruiting

  • Psoriahue

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKG

    Gabriel Magariños, Site 0119, 5401148238755

    Recruiting

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

    Cecilia Santarelli, Site 0117, 381 5537821

    Recruiting

Other trials in Argentina

Brazil7 sites, 7 recruiting

  • Local Institution - 0284

    Campinas, São Paulo, 13086-888

    Site 0284

    Not yet recruiting

  • Hospital Universitário Evangélico Mackenzie

    Curitiba, Paraná, 80730-150

    Lincoln Fabricio, Site 0168, +55 41 3022-3482

    Recruiting

  • Local Institution - 0182

    Porto Alegre, Rio Grande do Sul, 90035-903

    Site 0182

    Not yet recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560-032

    André Carvalho, Site 0136, +5551993785952

    Recruiting

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP

    Ribeirão Preto, São Paulo, 14051-140

    Cacilda da Silva Souza, Site 0163, 551636022302

    Recruiting

  • Centro de Pesquisas da Clínica IBIS

    Salvador, Estado de Bahia, 41820-020

    Gleison Duarte, Site 0137, +557199628-2914

    Recruiting

  • Local Institution - 0170

    São Paulo, 05403-000

    Site 0170

    Not yet recruiting

Other trials in Brazil

Mexico7 sites, 7 recruiting

  • Local Institution - 0259

    Chihuahua City, 31217

    Site 0259

    Not yet recruiting

  • Local Institution - 0257

    Mérida, 97070

    Site 0257

    Not yet recruiting

  • Local Institution - 0253

    Mexico City, Mexico City, 06720

    Site 0253

    Not yet recruiting

  • Local Institution - 0155

    Monterrey, Nuevo León, 64718

    Site 0155

    Not yet recruiting

  • Local Institution - 0258

    Toluca, 50010

    Site 0258

    Not yet recruiting

  • Arké SMO S.A de C.V

    Veracruz, 91900

    Claudia Bernabe del Rio, Site 0096, +522299314102

    Recruiting

  • Instituto Dermatologico de Jalisco

    Zapopan, Jalisco, 45190

    Jose Alfredo Ortiz, Site 0238, 3339549360

    Recruiting

Other trials in Mexico

Germany5 sites, 5 recruiting

  • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

    Berlin, 10117

    Sonja Molin, Site 0211, 030450618343

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

    Susanne Abraham, Site 0204, +493514583401

    Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

    Lukas Sollfrank, Site 0193, 091318533861

    Recruiting

  • BAG Drs. Med. Quist PartG

    Mainz, Rhineland-Palatinate, 55128

    Sven Quist, Site 0194, 00496131 9722360

    Recruiting

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

    Nina Magnolo, Site 0195, 0049-251-8356558

    Recruiting

Other trials in Germany

Spain5 sites, 5 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [Cataluña], 08041

    Anna Lopez Ferrer, Site 0198, +34935537007

    Recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona], 08950

    Asuncion Vicente Villa, Site 0218, 936009733(ext.70034)

    Recruiting

  • Grupo Dermatológico y Estético Pedro Jaén S.A

    Madrid, 28002

    Alvaro Gonzalez-Cantero, Site 0196, +34620408898

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Raquel Rivera-Diaz, Site 0216, 34917792260

    Recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, 15706

    Isabel Rodríguez Blanco, Site 0197, 0034981956011

    Recruiting

Other trials in Spain

Belgium4 sites, 3 recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région de, 1200

    Pierre-Dominique Ghislain, Site 0209, 3227641472

    Recruiting

  • Local Institution - 0210

    Brussels, Bruxelles-Capitale, Région de, 1200

    Withdrawn

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

    Sofie De Schepper, Site 0207, 003293322287

    Recruiting

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

    Liège, 4000

    ARJEN NIKKELS, Site 0208, +3243237232

    Recruiting

Other trials in Belgium

Colombia4 sites, 4 recruiting

  • Local Institution - 0167

    Barranquilla, Atlántico, 080002

    Site 0167

    Not yet recruiting

  • Local Institution - 0125

    Bogota, Cundinamarca, 111 411

    Site 0125

    Not yet recruiting

  • Local Institution - 0225

    Medellín, Antioquia, 050012

    Site 0225

    Not yet recruiting

  • Local Institution - 0124

    Medellín, Antioquia, 50021

    Site 0124

    Not yet recruiting

Other trials in Colombia

Taiwan4 sites, 4 recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

    Chien-Hui Hong, Site 0201, 886-7-3422121x74300

    Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

    Ji-Chen Ho, Site 0114, 886 77317123 x2426

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Tsen-Fang Tsai, Site 0113, 886223123456

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Yu-Huei Huang, Site 0112, 886975360157

    Recruiting

Other trials in Taiwan

Hungary3 sites, 3 recruiting

  • Clinexpert Kft.

    Budapest, Pest County, 1033

    Dorottya Asboth, Site 0153, +3612108139

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Andrea Szegedi, Site 0133, +3652255204

    Recruiting

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád megye, 6720

    Zsanett Csoma, Site 0203, 36304723487

    Recruiting

Other trials in Hungary

Puerto Rico3 sites, 3 recruiting

  • Local Institution - 0254

    Bayamón, 00960

    Site 0254

    Not yet recruiting

  • Local Institution - 0008

    Caguas, 00725

    Site 0008

    Not yet recruiting

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

    Jose Gonzalez Chavez, Site 0012, 0000000000

    Recruiting

Other trials in Puerto Rico

Italy2 sites, 2 recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168

    Ketty Peris, Site 0188, 39 0630154227

    Recruiting

  • Fondazione Policlinico Tor Vergata

    Rome, Lazio, 00133

    Luca Bianchi, Site 0187, 00390620902739

    Recruiting

Other trials in Italy

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

Being tested
Deucravacitinib, Placebo
Keywords
Psoriasis, Rash, Itch, Teen, Dermatology, Derm, POETYK-PsO-Peds-1
Medical subject headings
Psoriasis, Exanthema, Pruritus

What participants receive

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

  • DeucravacitinibDrug

    Also called BMS-986165

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT06979453
Study groupRoleWhat they receive
Administration of DeucravacitinibActive comparatorNot described
Receives: Drug: Deucravacitinib
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

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

  1. Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)

    Measured: At week 16

  2. Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline

    Measured: At week 16

Secondary outcomes (18)

  1. Number of participants achieving at least 90% improvement in PASI (PASI 90)

    Measured: At week 16

  2. Change from baseline in PASI

    Measured: At week 16

  3. Change from baseline in body surface area (BSA) involvement

    Measured: At week 16

  4. Change from baseline in worst itch numeric rating scale (WI-NRS)

    Measured: At week 16

  5. Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)

    Measured: At week 16

  6. Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score

    Measured: At week 16

  7. Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2)

    Measured: At week 16

  8. Number of participants with treatment emergent adverse events

    Measured: Up to 5 years

  9. Number of participants with serious adverse events

    Measured: Up to 5 years

  10. Number of participants with clinically significant changes in laboratory parameters

    Measured: Up to 5 years

  11. Number of participants with clinically significant changes in physical examinations

    Measured: Up to 5 years

  12. Number of participants with clinically significant changes in vital signs

    Measured: Up to 5 years

  13. Number of participants with protective titers of antibodies to measles

    Measured: At week 16

  14. Number of participants with protective titers of antibodies to tetanus

    Measured: At week 16

  15. Number of participants with protective titers of antibodies to pertussis

    Measured: At week 16

  16. Body weight

    Measured: Up to 5 years

  17. Height

    Measured: Up to 5 years

  18. Sexual maturation

    Measured: Up to 5 years

Timeline

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

  1. First posted20 May 2025
  2. Study start3 Dec 2025
  3. Primary completion12 Oct 2029 (estimated)
  4. Study completion12 Aug 2034 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979453
Sponsor's protocol ID
IM011-1128
Other IDs
2023-506296-97, U1111-1289-8030, 2023
Acronym
POETYK-PsO-Ped
Status last verified
Oct 2026
First submitted
13 May 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Deucravacitinib in people with Plaque Psoriasis, run by Bristol-Myers Squibb at 133 sites in 16 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, China, Canada, Poland, Romania and 11 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) (time frame: At week 16). The study lists 2 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 NCT06979453.

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 27 Oct 2026.

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