Clinical trial Recruiting at 45 sites Phase 3 Interventional Ages 4 to 18

Evaluating Deucravacitinib for Pediatric Plaque Psoriasis

Official title: 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

Run by Bristol-Myers Squibb · NCT04772079 · Data updated 2026-11-12

This study is testing a new medication called Deucravacitinib to see if it helps children and teens with moderate to severe plaque psoriasis feel better and is safe for them to use.

Quick facts

PhasePhase 3
Study typeInterventional
Ages4 Years to 18 Years
SexAll
Enrollment153 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionsdeucravacitinib
Locations65 sites (Ciudad Autonoma de Buenos Aires, Buenos Aires and 64 other locations)
StatusRecruiting
StartedMarch 23, 2021
Main results expectedJanuary 1, 2029
Study endsSeptember 8, 2033
Registry record updatedOctober 26, 2026
Trial IDNCT04772079 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include males and females aged 4 to less than 18 years with a diagnosis of moderate to severe plaque psoriasis.

Probably not a fit

Patients with other forms of psoriasis or those who have previously been treated with deucravacitinib may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the drug levels, efficacy, and safety of Deucravacitinib in children and adolescents aged 4 to less than 18 years with moderate to severe plaque psoriasis. The study is divided into two cohorts based on age, with Part A focusing on determining appropriate dosing and Part B evaluating the treatment's effectiveness and safety. Participants who complete the initial phases will have the opportunity to enter a long-term extension period to monitor ongoing safety and tolerability.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for pediatric patients suffering from moderate to severe plaque psoriasis.

How similar studies have gone: Other studies evaluating similar treatments for plaque psoriasis have shown promising results, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria

* 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.

Exclusion Criteria

* 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 forms of psoriasis.
* History of recent infection.
* Prior exposure to deucravacitinib (BMS-986165) or another active comparator.
* Evidence of active TB for LTE period.
* Other protocol-defined inclusion/exclusion criteria apply.

Where it's running

  • Instituto de Neumonologia Y Dermatologia
    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
    Recruiting
  • Psoriahue
    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
    Recruiting
  • CONEXA Investigacion Clinica S.A.
    Buenos Aires, Argentina
    Recruiting
  • Centro de Investigaciones Metabólicas (CINME)
    Buenos Aires, Argentina
    Recruiting
  • Hospital Italiano de Buenos Aires
    Caba, Argentina
    Recruiting
  • Consultora Integral de Salud
    Córdoba, Argentina
    Recruiting
Show 44 more locations
  • Queensland Children's Hospital
    Brisbane, Queensland, Australia
    Recruiting
  • Monash Health
    Clayton, Victoria, Australia
    Recruiting
  • Centro de Pesquisas da Clínica IBIS
    Salvador, Estado de Bahia, Brazil
    Recruiting
  • Hospital Moinhos de Vento
    Porto Alegre, Rio Grande do Sul, Brazil
    Recruiting
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
    Ribeirão Preto, São Paulo, Brazil
    Recruiting
  • Alberta Dermasurgery Centre
    Edmonton, Alberta, Canada
    Recruiting
  • Lynderm Research Inc.
    Markham, Ontario, Canada
    Recruiting
  • The Hospital for Sick Children
    Toronto, Ontario, Canada
    Recruiting
  • Centre Hospitalier de Calais
    Calais, France
    Recruiting
  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
    Dijon, France
    Recruiting
  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
    Nice, France
    Recruiting
  • Universitätsklinikum Münster
    Münster, North Rhine-Westphalia, Germany
    Recruiting
  • Universitätsmedizin Johannes Gutenberg Universität Mainz
    Mainz, Rhineland-Palatinate, Germany
    Recruiting
  • Universitaetsklinikum Carl Gustav Carus Dresden
    Dresden, Saxony, Germany
    Recruiting
  • Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
    Berlin, Germany
    Recruiting
  • Kath. Kinderkrankenhaus Wilhelmstift
    Hamburg, Germany
    Recruiting
  • Nagoya City University Hospital
    Nagoya, Aichi-ken, Japan
    Recruiting
  • Fukuoka University Hospital
    Fukuoka, Jonan-Ku, Fukuoka, Japan
    Recruiting
  • Mie University Hospital
    Tsu, Mie-ken, Japan
    Recruiting
  • Tokyo Medical University Hospital
    Shinjuku-ku, Tokyo, Japan
    Recruiting
  • Teikyo University Hospital
    tabashi City, Tokyo, Japan
    Recruiting
  • Nippon Life Hospital
    Osaka, Japan
    Recruiting
  • Crea de Guadalajara
    Guadalajara, Jalisco, Mexico
    Recruiting
  • Grupo Clínico CATEI S.C.
    Guadalajara, Jalisco, Mexico
    Recruiting
  • Arké SMO S.A de C.V
    Veracruz, Mexico
    Recruiting
  • Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
    Lodz, Poland
    Recruiting
  • Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii
    Warsaw, Poland
    Recruiting
  • WroMedica
    Wroclaw, Poland
    Recruiting
  • CCBR Clinical Research
    Bucharest, Bucharest, Romania
    Recruiting
  • Lotus-Med Tunari
    Bucharest, Romania
    Recruiting
  • Spitalul clinic de urgenta pentru copii Sf. Maria
    Iași, Romania
    Recruiting
  • Spitalul Clinic Judetean Mures
    Târgu Mureş, Romania
    Recruiting
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    Seoul, Seoul-teukbyeolsi [Seoul], South Korea
    Recruiting
  • Hospital General Universitario de Alicante-Dermatology
    Alicante, Spain
    Recruiting
  • Hospital Sant Joan de Déu-URC Dermatology
    Esplugues de Llobregat, Spain
    Recruiting
  • Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
    Las Palmas de GC, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre-DERMATOLOGY
    Madrid, Spain
    Recruiting
  • Hospital Universitario La Paz-UCICEC/DERMA
    Madrid, Spain
    Recruiting
  • Mounts Bay Medical
    Connor Downs, United Kingdom
    Recruiting
  • Local Institution - 0020
    Darlinghurst, New South Wales, Australia
    Active not recruiting
  • Local Institution - 0002
    Westmead, New South Wales, Australia
    Withdrawn
  • Local Institution - 0003
    Woolloongabba, Queensland, Australia
    Completed
  • Local Institution - 0001
    Melbourne, Victoria, Australia
    Completed
  • Local Institution - 0083
    Rio de Janeiro, Brazil
    Withdrawn

+15 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.