A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis

Last updated: June 5, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

3

Condition

Warts

Rosacea

Psoriasis And Psoriatic Disorders

Treatment

Placebo matching deucravacitinib

Deucravacitinib

Clinical Study ID

NCT04772079
IM011-126
2022-502519-13
2019-004879-39
  • Ages 4-18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 153
Treatment Group(s): 2
Primary Treatment: Placebo matching deucravacitinib
Phase: 3
Study Start date:
March 23, 2021
Estimated Completion Date:
September 08, 2033

Connect with a study center

  • Instituto de Neumonologia Y Dermatologia

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
    Argentina

    Active - Recruiting

  • Instituto de Neumonología Y Dermatología

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
    Argentina

    Active - Recruiting

  • Local Institution - 0042

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
    Argentina

    Active - Recruiting

  • Local Institution - 0045

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
    Argentina

    Active - Recruiting

  • Psoriahue

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG
    Argentina

    Active - Recruiting

  • Local Institution - 0044

    Ciudad Autónoma de Buenos Aires, Buenos Aires 1056
    Argentina

    Site Not Available

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Local Institution - 0043

    Buenos Aires, 1181
    Argentina

    Site Not Available

  • Local Institution - 0058

    Buenos Aires, 1012
    Argentina

    Active - Recruiting

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires 3435910, 1012
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    CABA, 1199
    Argentina

    Active - Recruiting

  • Local Institution - 0043

    Caba, 1199
    Argentina

    Active - Recruiting

  • Consultora Integral de Salud

    Córdoba, 5004
    Argentina

    Active - Recruiting

  • Local Institution - 0089

    Córdoba, 5004
    Argentina

    Site Not Available

  • The Skin Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • The Skin Hospital

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Local Institution

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Local Institution - 0002

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Local Institution - 0072

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Queensland Children's Hospital

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Local Institution - 0003

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Veracity Clinical Research

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Local Institution - 0001

    Melbourne, Victoria 3995
    Australia

    Completed

  • Local Institution - 0069

    Salvador, Bahia 41820-020
    Brazil

    Site Not Available

  • Centro de Pesquisas da Clínica IBIS

    Salvador, Estado de Bahia 41820-020
    Brazil

    Active - Recruiting

  • Local Institution - 0070

    Porto Alegre, Rio Grande Do Sul 90035001
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul 90560-032
    Brazil

    Active - Recruiting

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Active - Recruiting

  • Local Institution - 0064

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Site Not Available

  • Local Institution - 0083

    Rio de Janeiro, 22470-220
    Brazil

    Site Not Available

  • Local Institution - 0067

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Local Institution - 0010

    Calgary, Alberta T2J 7E1
    Canada

    Completed

  • Alberta Dermasurgery Centre

    Edmonton, Alberta T6G 1C3
    Canada

    Active - Recruiting

  • Local Institution - 0037

    Edmonton, Alberta T6G 1C3
    Canada

    Active - Recruiting

  • Local Institution - 0039

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Local Institution - 0008

    Markham, Ontario L3P 1X2
    Canada

    Active - Recruiting

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X3
    Canada

    Active - Recruiting

  • Local Institution - 0050

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Centre Hospitalier de Calais

    Calais, 62107
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology

    Dijon, 21000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, 06202
    France

    Active - Recruiting

  • Hopital Robert Debre

    Paris, 75019
    France

    Completed

  • Local Institution - 0021

    Paris, 75019
    France

    Completed

  • Local Institution - 0077

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia 48149
    Germany

    Active - Recruiting

  • Local Institution - 0075

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate 55131
    Germany

    Active - Recruiting

  • Local Institution - 0073

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117
    Germany

    Active - Recruiting

  • Local Institution - 0076

    Berlin, 10117
    Germany

    Site Not Available

  • Kath. Kinderkrankenhaus Wilhelmstift

    Hamburg, 22149
    Germany

    Active - Recruiting

  • Local Institution - 0074

    Hamburg, 22149
    Germany

    Site Not Available

  • Local Institution - 0033

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi-ken 467-8602
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka, Jonan-Ku, Fukuoka 814-0180
    Japan

    Active - Recruiting

  • Local Institution - 0032

    Fukuoka, Jonan-Ku, Fukuoka 814-0180
    Japan

    Active - Recruiting

  • Local Institution - 0040

    Isehara, Kanagawa 259-1193
    Japan

    Site Not Available

  • Local Institution - 0038

    Tsu, Mie 514-8507
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu, Mie-ken 514-8507
    Japan

    Active - Recruiting

  • Local Institution - 0034

    Itabashi-ku, Tokyo 173-8606
    Japan

    Active - Recruiting

  • Teikyo University Hospital

    Itabashi-ku, Tokyo 173-8606
    Japan

    Active - Recruiting

  • Local Institution - 0041

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Local Institution - 0035

    Osaka, 550-0006
    Japan

    Active - Recruiting

  • Nippon Life Hospital

    Osaka, 550-0006
    Japan

    Active - Recruiting

  • Local Institution - 0047

    Seoul, Seoul-teukbyeolsi [Seoul] 03722
    Korea, Republic of

    Completed

  • Local Institution - 0048

    Seoul, Seoul-teukbyeolsi [Seoul] 02447
    Korea, Republic of

    Completed

  • Local Institution - 0059

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    Korea, Republic of

    Active - Recruiting

  • Local Institution - 0052

    Mexico City, Distrito Federal 03100
    Mexico

    Active - Recruiting

  • Centro de Atención en Enfermedades Inflamatorias CATEI

    Guadalajara, Jalisco 44638
    Mexico

    Active - Recruiting

  • Crea de Guadalajara

    Guadalajara, Jalisco 44600
    Mexico

    Active - Recruiting

  • Grupo Clínico CATEI S.C.

    Guadalajara, Jalisco 44638
    Mexico

    Active - Recruiting

  • Local Institution - 0054

    Guadalajara, Jalisco 44600
    Mexico

    Active - Recruiting

  • Local Institution - 0057

    Guadalajara, Jalisco 44638
    Mexico

    Active - Recruiting

  • Crea de Guadalajara

    Guadalajara 4005539, Jalisco 4004156 44600
    Mexico

    Active - Recruiting

  • RM Pharma Specialists

    Mexico City, Mexico City 03100
    Mexico

    Active - Recruiting

  • Arké SMO S.A de C.V

    Veracruz, 91910
    Mexico

    Active - Recruiting

  • Local Institution - 0053

    Veracruz, 91910
    Mexico

    Active - Recruiting

  • Local Institution - 0011

    Krakow, 30-438
    Poland

    Completed

  • Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436
    Poland

    Active - Recruiting

  • Local Institution - 0006

    Lodz, 90-436
    Poland

    Active - Recruiting

  • Local Institution - 0004

    Warsaw, 02-507
    Poland

    Active - Recruiting

  • Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii

    Warsaw, 02-507
    Poland

    Active - Recruiting

  • Local Institution

    Warszawa, 02-507
    Poland

    Active - Recruiting

  • Local Institution - 0005

    Wroclaw, 51-620
    Poland

    Active - Recruiting

  • WroMedica

    Wroclaw, 51-620
    Poland

    Active - Recruiting

  • CCBR Clinical Research

    Bucharest, Bucharest 30463
    Romania

    Active - Recruiting

  • Local Institution - 0080

    Bucharest, Bucharest 012292
    Romania

    Site Not Available

  • Local Institution - 0081

    Bucharest, Bucharest 020125
    Romania

    Site Not Available

  • Local Institution - 0088

    Bucharest, Bucharest 020762
    Romania

    Site Not Available

  • Local Institution - 0081

    Bucuresti, București 020125
    Romania

    Site Not Available

  • Local Institution - 0082

    Bucuresti, București 30463
    Romania

    Site Not Available

  • CCBR Clinical Research

    Bucharest 683506, București 683504 30463
    Romania

    Active - Recruiting

  • Local Institution - 0080

    Bucharest 683506, București 683504 012292
    Romania

    Site Not Available

  • Local Institution - 0081

    Bucharest 683506, București 683504 020125
    Romania

    Site Not Available

  • Local Institution - 0088

    Bucharest 683506, București 683504 020762
    Romania

    Site Not Available

  • Lotus-Med Tunari

    Bucharest 683506, București 683504 020528
    Romania

    Active - Recruiting

  • Local Institution - 0079

    Iasi, Iași 700309
    Romania

    Site Not Available

  • Local Institution - 0087

    Bucharest, 020528
    Romania

    Site Not Available

  • Lotus-Med Tunari

    Bucharest, 020528
    Romania

    Active - Recruiting

  • Spitalul clinic de urgenta pentru copii Sf. Maria

    Iași, 700309
    Romania

    Active - Recruiting

  • Local Institution - 0078

    Targu Mures, 540342
    Romania

    Site Not Available

  • Spitalul Clinic Judetean Mures

    Târgu Mureş, 540342
    Romania

    Active - Recruiting

  • Local Institution - 0047

    Seoul, Seoul-teukbyeolsi [Seoul] 03722
    South Korea

    Completed

  • Local Institution - 0048

    Seoul, Seoul-teukbyeolsi [Seoul] 02447
    South Korea

    Completed

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 06591
    South Korea

    Active - Recruiting

  • Local Institution - 0047

    Seoul 1835848, Seoul-teukbyeolsi [Seoul] 03722
    South Korea

    Completed

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul 1835848, Seoul-teukbyeolsi [Seoul] 06591
    South Korea

    Active - Recruiting

  • Hospital General Universitario de Alicante-Dermatology

    Alicante, 03010
    Spain

    Active - Recruiting

  • Local Institution

    Alicante, 03010
    Spain

    Active - Recruiting

  • Local Institution - 0017

    Alicante, 03010
    Spain

    Active - Recruiting

  • Local Institution

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Local Institution - 0026

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Hospital Sant Joan de Déu-URC Dermatology

    Esplugues de Llobregat, 08950
    Spain

    Active - Recruiting

  • Local Institution

    Esplugues de Llobregat, 08950
    Spain

    Active - Recruiting

  • Local Institution - 0014

    Esplugues de Llobregat, 08950
    Spain

    Active - Recruiting

  • Local Institution

    Las Palmas De GC, 35019
    Spain

    Active - Recruiting

  • Local Institution - 0016

    Las Palmas De GC, 35019
    Spain

    Active - Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología

    Las Palmas de GC, 35019
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre-DERMATOLOGY

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz-UCICEC/DERMA

    Madrid, 28046
    Spain

    Active - Recruiting

  • Local Institution

    Madrid, 28041
    Spain

    Active - Recruiting

  • Local Institution - 0022

    Madrid, 28046
    Spain

    Active - Recruiting

  • Local Institution - 0027

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz-UCICEC/DERMA

    Madrid 3117735, 28046
    Spain

    Active - Recruiting

  • Local Institution - 0029

    London, London, City Of WC1N 3JH
    United Kingdom

    Site Not Available

  • Local Institution - 0019

    Connor Downs, TR27 5DT
    United Kingdom

    Active - Recruiting

  • Mounts Bay Medical

    Connor Downs, TR27 5DT
    United Kingdom

    Active - Recruiting

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