NCT06979453RecruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 366 (estimated)
- First submitted
- 13 May 2025
- Start date
- 3 Dec 2025
- Primary completion date
- 12 Oct 2029
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Psoriasis
- NCT number
- NCT06979453
- EU CT number
- 2023-506296-97-00
- EudraCT number
- 2023-506296-97
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 366
- From 3 Dec 2025 to the primary completion date, 12 Oct 2029
- 131 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- 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 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.
- 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.
Lab values
- Participants must not have a laboratory finding that is exclusionary.
Other
- Participants must not weigh \< 30.0 kg at Screening and Day 1.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (131)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CONEXA Investigacion Clinica S.A. Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital de Niños Dr. Ricardo Gutiérrez Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Derma Internacional Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Instituto de Neumonologia Y Dermatologia Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Recruiting |
| Psoriahue Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Recruiting |
| Centro de Investigaciones Médicas Tucuman Coordinator of this site? Confirm its status | SAN M. de Tucuman | Argentina | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| - Coordinator of this site? Confirm its status | Campinas | Brazil | Not yet recruiting |
| Hospital Universitário Evangélico Mackenzie Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Not yet recruiting |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| Centro de Pesquisas da Clínica IBIS Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Alberta Dermasurgery Centre Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Dermeffects Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| The Centre for Dermatology Coordinator of this site? Confirm its status | Richmond Hill | Canada | Recruiting |
| Skincare Studio Coordinator of this site? Confirm its status | St. John's | Canada | Recruiting |
| AvantDerm Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| - Coordinator of this site? Confirm its status | Winnipeg | Canada | Not yet recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Children's Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Children's Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| - Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Guangdong Province Dermatology Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Affiliated Hospital of Hebei University of Engineering Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| The First People's Hospital of Hangzhou Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Shandong Provincial Dermatology Hospital and Shandong Institute of Dermatology and Venereology Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Shanghai Skin Disease Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The University of Hong Kong-Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| People's Hospital of Henan Province Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Barranquilla | Colombia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Bogota | Colombia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Medellín | Colombia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Medellín | Colombia | Not yet recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
| BAG Dres. med. Quist PartG Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Sant Joan de Déu Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Grupo Pedro Jaén Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| CHUS - Hospital Clinico Universitario Coordinator of this site? Confirm its status | Santiago de Compostela- A Coruna | Spain | Recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Università Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Mérida | Mexico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Monterrey | Mexico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Toluca | Mexico | Not yet recruiting |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Recruiting |
| Instituto Dermatologico de Jalisco Coordinator of this site? Confirm its status | Zapopan | Mexico | Recruiting |
| Specderm Poznanska sp.j. Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| La Clinique Centrum Dermatologii i Estetyki Coordinator of this site? Confirm its status | Garwolin | Poland | Recruiting |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Royalderm Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Klinika Ambroziak Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| - Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Not yet recruiting |
| GCM Medical Group, PSC - Hato Rey Site Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Policlinica CCBR S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Lotus Med S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Centrul de Medicina de Familie Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Policlinica Providența Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| New Derm Clinical SRL Coordinator of this site? Confirm its status | Timișoara | Romania | Recruiting |
| Kaohsiung Veterans General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Chang Gung Memorial Hospital at Kaohsiung Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| - Coordinator of this site? Confirm its status | Ammon | United States | Not yet recruiting |
| Dermatology Affiliates Research Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Birmingham | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Birmingham | United States | Withdrawn |
| Apex Clinical Research Center - Canton Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Clearwater | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Clifton | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Columbia | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Columbia | United States | Not yet recruiting |
| Henry Ford Medical Center Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| C.S. Mott Clinical Research Center (CRC) Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Fountain Valley | United States | Not yet recruiting |
| Center For Dermatology Clinical Research, Inc. Coordinator of this site? Confirm its status | Fremont | United States | Recruiting |
| ObjectiveHealth - Goodlettsville Dermatology Research Coordinator of this site? Confirm its status | Goodlettsville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Hickory | United States | Completed |
| - Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Dawes Fretzin Clinical Research Group, LLC Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| JDR Dermatology Research Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Dermatology and Skin Cancer Center Coordinator of this site? Confirm its status | Lee's Summit | United States | Recruiting |
| Apex Clinical Research Center Coordinator of this site? Confirm its status | Lorain | United States | Recruiting |
| Dermatology Research Associates Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Life Clinical Trials Coordinator of this site? Confirm its status | Margate | United States | Recruiting |
| Apex Clinical Research Center Coordinator of this site? Confirm its status | Mayfield Heights | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Metairie | United States | Not yet recruiting |
| Skin Research of South Florida Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Wellness Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Kuchnir Dermatology & Dermatologic Surgery Coordinator of this site? Confirm its status | Milford | United States | Recruiting |
| Frontier Derm Partners Coordinator of this site? Confirm its status | Mill Creek | United States | Recruiting |
| Kentucky Advanced Medical Research LLC Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Nashville | United States | Completed |
| - Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Norfolk | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Northridge | United States | Active, not recruiting |
| Paddington Testing Company Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Phoenix | United States | Withdrawn |
| Aura Dermatology Coordinator of this site? Confirm its status | Robbinsville | United States | Recruiting |
| Dermatology and Skin Cancer Specialists, LLC Coordinator of this site? Confirm its status | Rockville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Sacramento | United States | Not yet recruiting |
| Texas Dermatology and Laser Specialists Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Advanced Medical Research, PC. Coordinator of this site? Confirm its status | Sandy Springs | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Southlake | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Spokane | United States | Not yet recruiting |
| USF Health Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| - Coordinator of this site? Confirm its status | The Bronx | United States | Not yet recruiting |
| Golden State Dermatology - Walnut Creek - Ygnacio Valley Road Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Paradigm Clinical Research, LLC Coordinator of this site? Confirm its status | Wheat Ridge | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.