NCT04772079RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (estimated)
- First submitted
- 24 Feb 2021
- Start date
- 23 Mar 2021
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Psoriasis
- NCT number
- NCT04772079
- EU CT number
- 2022-502519-13-00
- EudraCT number
- 2019-004879-39
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 153
- From 23 Mar 2021 to the primary completion date, 1 Jan 2029
- 62 sites in 13 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
- Prior exposure to deucravacitinib (BMS-986165) or another active comparator.
Other illness
- History of recent infection.
Age
- Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing \< 18.0 kg at screening for Cohort 2 (age 4 to \< 12 years), Part A and Part B.
Other
- Other forms of psoriasis.
- Evidence of active TB for LTE period.
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- Males and females aged 12 to \<18 years for Cohort 1. Males and females aged 4 to \<12 years for Cohort 2.
- Plaque psoriasis for at least 6 months.
- Moderate to severe disease.
- Candidate for phototherapy or systemic therapy.
- Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (62)
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 |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | CABA | 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 |
| Consultora Integral de Salud Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Queensland Children's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Darlinghurst | Australia | Active, not recruiting |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Melbourne | Australia | Completed |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Westmead | Australia | Withdrawn |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Woolloongabba | Australia | Completed |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | 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 |
| Local Institution - 0083 Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Withdrawn |
| Centro de Pesquisas da Clínica IBIS Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Local Institution - 0067 Coordinator of this site? Confirm its status | São Paulo | Brazil | Withdrawn |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Calgary | Canada | Completed |
| Alberta Dermasurgery Centre Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Local Institution - 0039 Coordinator of this site? Confirm its status | Hamilton | Canada | Withdrawn |
| Lynderm Research Inc. Coordinator of this site? Confirm its status | Markham | Canada | Recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | 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 |
| Katholisches Kinderkrankenhaus Wilhelmstift gGmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Hospital General Universitario de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Recruiting |
| Hospital Universitario de Gran Canaria Dr Negrín Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centre Hospitalier Dr Jean-Eric TECHER Coordinator of this site? Confirm its status | Calais | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Mounts Bay Medical Coordinator of this site? Confirm its status | Connor Downs | United Kingdom | Recruiting |
| Local Institution - 0092 Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Local Institution - 0029 Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka, Jonan-Ku | Japan | Recruiting |
| Local Institution - 0040 Coordinator of this site? Confirm its status | Isehara | Japan | Withdrawn |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Nippon Life Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Recruiting |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Recruiting |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Local Institution - 0047 Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Local Institution - 0048 Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Grupo Clínico CATEI S.C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Crea de Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Local Institution - 0052 Coordinator of this site? Confirm its status | Mexico City | Mexico | Completed |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Recruiting |
| Specjalistyczny Gabinet Dermatologiczno- Kosmetyczny Coordinator of this site? Confirm its status | Kraków | Poland | Recruiting |
| Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| WroMedica I Bielicka A Strzalkowska s c Coordinator of this site? Confirm its status | Wroclaw | Poland | 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 De Urgenta Pentru Copii Sfanta Maria Iasi Coordinator of this site? Confirm its status | Jassi | Romania | Recruiting |
| Spitalul Clinic Judeţean Mureş Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.