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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Enrollment | 153 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | deucravacitinib |
| Locations | 65 sites (Ciudad Autonoma de Buenos Aires, Buenos Aires and 64 other locations) |
| Status | Recruiting |
| Started | March 23, 2021 |
| Main results expected | January 1, 2029 |
| Study ends | September 8, 2033 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT04772079 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
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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
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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
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term safety of deucravacitinib versus ustekinumab for plaque psoriasis (PRAGMATYK)
This study will test whether deucravacitinib or ustekinumab has better long-term safety for adults with moderate-to-severe plaque psoriasis who have cardiovascular risk factors.
-
Deucravacitinib for teens with moderate to severe plaque psoriasis
This trial will test whether deucravacitinib helps teens with moderate to severe plaque psoriasis while tracking safety and drug levels.
-
Comparing the effectiveness of deucravacitinib and apremilast for plaque psoriasis in adults in Japan
This study is testing whether a new medication called deucravacitinib works better than apremilast for adults with plaque psoriasis in Japan.
-
How safe and well ZP9830 works in people with plaque psoriasis over 8 weeks
This study tests whether ZP9830 is safe and tolerable in adults with plaque psoriasis for 8 weeks, with a comparison to placebo.
-
Secukinumab retention in adults with plaque psoriasis and MASLD in Spain
This study tests how long people with plaque psoriasis and MASLD stay on secukinumab in real-world Spain, using EMR data from several hospitals.
-
Deucravacitinib for scarring hair loss (frontal fibrosing and central centrifugal alopecia)
This trial will test whether taking deucravacitinib once daily for 48 weeks helps adults with frontal fibrosing alopecia or central centrifugal cicatricial alopecia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.