Sign in

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

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CONEXA Investigacion Clinica S.A.
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Centro de Investigaciones Metabólicas (CINME)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Hospital Italiano de Buenos Aires
Coordinator of this site? Confirm its status
CABAArgentinaRecruiting
Instituto de Neumonologia Y Dermatologia
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AiresArgentinaRecruiting
Psoriahue
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AiresArgentinaRecruiting
Consultora Integral de Salud
Coordinator of this site? Confirm its status
CórdobaArgentinaRecruiting
Queensland Children's Hospital
Coordinator of this site? Confirm its status
BrisbaneAustraliaRecruiting
Monash Health
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Local Institution - 0020
Coordinator of this site? Confirm its status
DarlinghurstAustraliaActive, not recruiting
Local Institution - 0001
Coordinator of this site? Confirm its status
MelbourneAustraliaCompleted
Local Institution - 0002
Coordinator of this site? Confirm its status
WestmeadAustraliaWithdrawn
Local Institution - 0003
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaCompleted
Hospital Moinhos de Vento
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
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 PretoBrazilRecruiting
Local Institution - 0083
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilWithdrawn
Centro de Pesquisas da Clínica IBIS
Coordinator of this site? Confirm its status
SalvadorBrazilRecruiting
Local Institution - 0067
Coordinator of this site? Confirm its status
São PauloBrazilWithdrawn
Local Institution - 0010
Coordinator of this site? Confirm its status
CalgaryCanadaCompleted
Alberta Dermasurgery Centre
Coordinator of this site? Confirm its status
EdmontonCanadaRecruiting
Local Institution - 0039
Coordinator of this site? Confirm its status
HamiltonCanadaWithdrawn
Lynderm Research Inc.
Coordinator of this site? Confirm its status
MarkhamCanadaRecruiting
The Hospital for Sick Children
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Technische Universitaet Dresden
Coordinator of this site? Confirm its status
DresdenGermanyRecruiting
Katholisches Kinderkrankenhaus Wilhelmstift gGmbH
Coordinator of this site? Confirm its status
HamburgGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Coordinator of this site? Confirm its status
MainzGermanyRecruiting
Universitaet Muenster
Coordinator of this site? Confirm its status
MuensterGermanyRecruiting
Hospital General Universitario de Alicante
Coordinator of this site? Confirm its status
AlicanteSpainRecruiting
Hospital Universitario de Cruces
Coordinator of this site? Confirm its status
BarakaldoSpainRecruiting
Sant Joan De Deu Barcelona Hospital
Coordinator of this site? Confirm its status
Esplugues De LlobregatSpainRecruiting
Hospital Universitario de Gran Canaria Dr Negrín
Coordinator of this site? Confirm its status
Las Palmas de Gran CanariaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Centre Hospitalier Dr Jean-Eric TECHER
Coordinator of this site? Confirm its status
CalaisFranceRecruiting
Centre Hospitalier Universitaire de Dijon
Coordinator of this site? Confirm its status
DijonFranceRecruiting
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Mounts Bay Medical
Coordinator of this site? Confirm its status
Connor DownsUnited KingdomRecruiting
Local Institution - 0092
Coordinator of this site? Confirm its status
LondonUnited KingdomNot yet recruiting
Local Institution - 0029
Coordinator of this site? Confirm its status
LondonUnited KingdomNot yet recruiting
Fukuoka University Hospital
Coordinator of this site? Confirm its status
Fukuoka, Jonan-KuJapanRecruiting
Local Institution - 0040
Coordinator of this site? Confirm its status
IseharaJapanWithdrawn
Nagoya City University Hospital
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
Nippon Life Hospital
Coordinator of this site? Confirm its status
OsakaJapanRecruiting
Tokyo Medical University Hospital
Coordinator of this site? Confirm its status
Shinjuku-kuJapanRecruiting
Teikyo University Hospital
Coordinator of this site? Confirm its status
tabashi CityJapanRecruiting
Mie University Hospital
Coordinator of this site? Confirm its status
TsuJapanRecruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Local Institution - 0047
Coordinator of this site? Confirm its status
SeoulSouth KoreaCompleted
Local Institution - 0048
Coordinator of this site? Confirm its status
SeoulSouth KoreaCompleted
Grupo Clínico CATEI S.C.
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting
Crea de Guadalajara
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting
Local Institution - 0052
Coordinator of this site? Confirm its status
Mexico CityMexicoCompleted
Arké SMO S.A de C.V
Coordinator of this site? Confirm its status
VeracruzMexicoRecruiting
Specjalistyczny Gabinet Dermatologiczno- Kosmetyczny
Coordinator of this site? Confirm its status
KrakówPolandRecruiting
Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
Coordinator of this site? Confirm its status
LodzPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
WroMedica I Bielicka A Strzalkowska s c
Coordinator of this site? Confirm its status
WroclawPolandRecruiting
Policlinica CCBR S.R.L.
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Lotus Med S.R.L.
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi
Coordinator of this site? Confirm its status
JassiRomaniaRecruiting
Spitalul Clinic Judeţean Mureş
Coordinator of this site? Confirm its status
Târgu MureşRomaniaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.