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Plaque PsoriasisPhase 3NCT04772079

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

A Phase 3 study testing Deucravacitinib in people with Plaque Psoriasis, run by Bristol-Myers Squibb at 65 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Deucravacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
65 sitesin 13 countries
Study dates
23 Mar 2021to 8 Sep 2033
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

65 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

65 sites in 13 countries

Japan7 sites, 6 recruiting

  • Fukuoka University Hospital

    Fukuoka, Jonan-Ku, Fukuoka, 814-0180

    Shinichi Imafuku, Site 0032, 81928011011

    Recruiting

  • Local Institution - 0040

    Isehara, Kanagawa, 259-1193

    Withdrawn

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173-8606

    Yayoi Tada, Site 0034, 81339641211

    Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

    Akimichi Morita, Site 0033, +81-52-851-5511

    Recruiting

  • Nippon Life Hospital

    Osaka, 550-0006

    Mari Higashiyama, Site 0035, +81664433446

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

    Yukari Okubo, Site 0041, 81-3-3342-6111

    Recruiting

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507

    Keiichi Yamanaka, Site 0038, 81-59-232-1111

    Recruiting

Other trials in Japan

Romania7 sites, 4 recruiting

  • Local Institution - 0080

    Bucharest, Bucharest, 012292

    Withdrawn

  • Local Institution - 0081

    Bucharest, Bucharest, 020125

    Withdrawn

  • Local Institution - 0088

    Bucharest, Bucharest, 020762

    Withdrawn

  • CCBR Clinical Research

    Bucharest, Bucharest, 30463

    Mara Mihai, Site 0082, 0040743364164

    Recruiting

  • Lotus-Med Tunari

    Bucharest, 020528

    Adelina-Maria Sendrea, Site 0087, 0040760930352

    Recruiting

  • Spitalul clinic de urgenta pentru copii Sf. Maria

    Iași, 700309

    Monica Cozorici, Site 0079, 0740303215

    Recruiting

  • Spitalul Clinic Judetean Mures

    Târgu Mureş, 540342

    Silviu Morariu, Site 0078, +40744757246

    Recruiting

Other trials in Romania

Argentina6 sites, 6 recruiting

  • CONEXA Investigacion Clinica S.A.

    Buenos Aires, 1012

    Pablo Gonzalez, Site 0058, +5491154140381

    Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

    Maria Laura Galimberti, Site 0044, 5491154583202

    Recruiting

  • Hospital Italiano de Buenos Aires

    CABA, 1199

    Maria Angles, Site 0043, +5491168360026

    Recruiting

  • Instituto de Neumonologia Y Dermatologia

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425

    Paula Luna, Site 0042, 5491145404644

    Recruiting

  • Psoriahue

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKG

    Gabriel Magariños, Site 0045, 5401148238755

    Recruiting

  • Consultora Integral de Salud

    Córdoba, 5004

    Veronica Savio, Site 0089, +5493515337844

    Recruiting

Other trials in Argentina

Australia6 sites, 2 recruiting

  • Queensland Children's Hospital

    Brisbane, Queensland, 4101

    Tania Zappala, Site 0072, 30681111

    Recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Francis Lai, Site 0046, 0395936666

    Recruiting

  • Local Institution - 0020

    Darlinghurst, New South Wales, 2010

    Active, not recruiting

  • Local Institution - 0001

    Melbourne, Victoria, 3995

    Completed

  • Local Institution - 0002

    Westmead, New South Wales, 2145

    Withdrawn

  • Local Institution - 0003

    Woolloongabba, Queensland, 4102

    Completed

Other trials in Australia

Spain6 sites, 6 recruiting

  • Hospital General Universitario de Alicante-Dermatology

    Alicante, 03010

    laura berbegal, Site 0017, +34965913723

    Recruiting

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

    Barakaldo, 48903

    Marta Mendieta Eckert, Site 0026, 946006149

    Recruiting

  • Hospital Sant Joan de Déu-URC Dermatology

    Esplugues de Llobregat, 08950

    Asuncion Vicente Villa, Site 0014, 936009733(ext.70034)

    Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología

    Las Palmas de GC, 35019

    ALICIA GONZALEZ QUESADA, Site 0016, +34928450659

    Recruiting

  • Hospital Universitario 12 de Octubre-DERMATOLOGY

    Madrid, 28041

    Raquel Rivera-Diaz, Site 0027, 34917792260

    Recruiting

  • Hospital Universitario La Paz-UCICEC/DERMA

    Madrid, 28046

    Raul de Lucas Laguna, Site 0022, 34917277231

    Recruiting

Other trials in Spain

Brazil5 sites, 3 recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560-032

    André Carvalho, Site 0070, +5551993785952

    Recruiting

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

    Ribeirão Preto, São Paulo, 14051-140

    Cacilda da Silva Souza, Site 0064, 551636022302

    Recruiting

  • Local Institution - 0083

    Rio de Janeiro, 22470-220

    Withdrawn

  • Centro de Pesquisas da Clínica IBIS

    Salvador, Estado de Bahia, 41820-020

    Gleison Duarte, Site 0069, +557199628-2914

    Recruiting

  • Local Institution - 0067

    São Paulo, 05403-000

    Withdrawn

Other trials in Brazil

Canada5 sites, 3 recruiting

  • Local Institution - 0010

    Calgary, Alberta, T2J 7E1

    Completed

  • Alberta Dermasurgery Centre

    Edmonton, Alberta, T6G 1C3

    Jaggi Rao, Site 0037, 587-487-0187

    Recruiting

  • Local Institution - 0039

    Hamilton, Ontario, L8N 1Y2

    Withdrawn

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X3

    Charles Lynde, Site 0008, 9054718011

    Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Rebecca Levy, Site 0050, 4168137654x428232

    Recruiting

Other trials in Canada

Germany5 sites, 5 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117

    Sonja Molin, Site 0076, 030450618343

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

    Susanne Abraham, Site 0073, +493514583401

    Recruiting

  • Kath. Kinderkrankenhaus Wilhelmstift

    Hamburg, 22149

    Peter Hoeger, Site 0074, 00494067377202

    Recruiting

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

    Petra Staubach-Renz, Site 0075, +496131175732

    Recruiting

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

    Nina Magnolo, Site 0077, 0049-251-8356558

    Recruiting

Other trials in Germany

France4 sites, 3 recruiting

  • Centre Hospitalier de Calais

    Calais, 62107

    Christopher COSSART, Site 0090, 0366256173

    Recruiting

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

    Dijon, 21000

    Bertille Bonniaud, Site 0028, 33380293336

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, 06202

    Thomas Hubiche, Site 0012, +33492036667

    Recruiting

  • Local Institution - 0021

    Paris, 75019

    Completed

Other trials in France

Mexico4 sites, 3 recruiting

  • Crea de Guadalajara

    Guadalajara, Jalisco, 44600

    Gabriel Vega Cornejo, Site 0054, 3314172229

    Recruiting

  • Grupo Clínico CATEI S.C.

    Guadalajara, Jalisco, 44638

    Delfina Villanueva Quintero, Site 0057, 3331151992

    Recruiting

  • Local Institution - 0052

    Mexico City, Mexico City, 03100

    Completed

  • Arké SMO S.A de C.V

    Veracruz, 91910

    Claudia Bernabe del Rio, Site 0053, +522299314102

    Recruiting

Other trials in Mexico

Poland4 sites, 3 recruiting

  • Local Institution - 0011

    Krakow, 30-438

    Completed

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

    Lodz, 90-436

    Joanna Narbutt, Site 0006, +48603756804

    Recruiting

  • Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii

    Warsaw, 02-507

    Irena Walecka Herniczek, Site 0004, 48603389394

    Recruiting

  • WroMedica

    Wroclaw, 51-620

    Wojciech Baran, Site 0005, +48 604058690

    Recruiting

Other trials in Poland

South Korea3 sites, 1 recruiting

  • Local Institution - 0048

    Seoul, Seoul-teukbyeolsi [Seoul], 02447

    Completed

  • Local Institution - 0047

    Seoul, Seoul-teukbyeolsi [Seoul], 03722

    Completed

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

    Seoul, Seoul-teukbyeolsi [Seoul], 06591

    JU HEE HAN, Site 0059, +821041383307

    Recruiting

Other trials in South Korea

United Kingdom3 sites, 3 recruiting

  • Mounts Bay Medical

    Connor Downs, TR27 5DT

    Richard Burkimsher, Site 0019, 01736 805460

    Recruiting

  • Local Institution - 0029

    London, London, City of, WC1N 3JH

    Site 0029

    Not yet recruiting

  • Local Institution - 0092

    London, SE1 7EH

    Site 0092

    Not yet recruiting

Other trials in United Kingdom

About this study

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

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.

Being tested
Deucravacitinib, Placebo matching deucravacitinib
Keywords
Adolescent Psoriasis, BMS-986165, Clinical trial, Deucravacitinib, Children Psoriasis, Pediatric Psoriasis, Plaque Psoriasis, Psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeucravacitinibDrug

    Specified dose on specified days

  • Placebo matching deucravacitinibOther

    Specified dose on specified days

Study groups in NCT04772079
Study groupRoleWhat they receive
Active treatment deucravacitinib standard doseExperimentalNot described
Receives: Drug: Deucravacitinib
Active treatment deucravacitinib half-standard doseExperimentalNot described
Receives: Drug: Deucravacitinib
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo matching deucravacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observed average concentration at steady state for deucravacitinib at Week 2

    Part A

    Measured: Week 2

  2. Maximum observed plasma concentration at steady state for deucravacitinib at Week 2

    Part A

    Measured: Week 2

  3. Trough observed plasma concentration for deucravacitinib at Week 2

    Part A

    Measured: Week 2

  4. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16

    Part B

    Measured: Week 16

  5. Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16

    Part B

    Measured: Week 16

  6. Incidence of Adverse Events (AEs)

    Long-term extension (LTE) Period

    Measured: Up to 316 weeks

  7. Incidence of serious adverse events (SAEs)

    LTE Period

    Measured: Up to 316 weeks

  8. Monitoring of growth: Body weight

    LTE Period

    Measured: Up to 316 weeks

  9. Monitoring of growth: Height

    LTE Period

    Measured: Up to 316 weeks

  10. Monitoring of growth: Tanner staging (sexual maturation)

    LTE Period

    Measured: Up to 316 weeks

Secondary outcomes (36)

  1. Incidence of Adverse Events (AEs)

    Part A and Part B

    Measured: Up to Week 52

  2. Incidence of serious adverse events (SAEs)

    Part A and Part B

    Measured: Up to Week 52

  3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Part A and Part B

    Measured: Up to Week 52

  4. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests

    Part A and Part B

    Measured: Up to Week 52

  5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Part A and Part B

    Measured: Up to Week 52

  6. Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests

    Part A and Part B

    Measured: Up to Week 52

  7. Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests

    Part A and Part B

    Measured: Up to Week 52

  8. Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests

    Part A and Part B

    Measured: Up to Week 52

  9. Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests

    Part A and Part B

    Measured: Up to Week 52

  10. Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only

    Part A and Part B

    Measured: Up to Week 52

  11. Incidence of clinically significant changes in lymphocyte subsets and function

    Part A and Part B

    Measured: Up to Week 52

  12. Incidence of clinically significant changes in cytokine levels

    Part A and Part B

    Measured: Up to Week 52

  13. Incidence of clinically significant changes in physical examination findings

    Part A and Part B

    Measured: Up to Week 52

  14. Incidence of clinically significant changes in vital signs: Body temperature

    Part A and Part B

    Measured: Up to Week 52

  15. Incidence of clinically significant changes in vital signs: Respiratory rate

    Part A and Part B

    Measured: Up to Week 52

  16. Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure

    Part A and Part B

    Measured: Up to Week 52

  17. Incidence of clinically significant changes in vital signs: Heart rate

    Part A and Part B

    Measured: Up to Week 52

  18. Monitoring of growth: Body weight

    Part A and Part B

    Measured: Up to Week 52

  19. Monitoring of growth: Height

    Part A and Part B

    Measured: Up to Week 52

  20. Monitoring of growth: Tanner staging (sexual maturation)

    Part A and Part B

    Measured: Up to Week 52

  21. Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  22. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  23. Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  24. Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  25. Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  26. Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  27. Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  28. Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  29. Proportion of subjects achieving Juvenile Idiopathic Arthritis and the American College of Rheumatology 30 (JIA-ACR 30) response at Week 16 for subjects with confirmed JPsA prior to baseline

    Part B

    JIA-ACR 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by > 30% for comparison of deucravacitinib vs placebo

    Measured: Week 16

  30. Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo

    Part B

    Measured: Week 16

  31. Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16

    Part B

    Measured: Week 16

  32. Observed average concentration at steady state for deucravacitinib at Week 16

    Part B

    Measured: Week 16

  33. Maximum observed plasma concentration at steady state for deucravacitinib at Week 16

    Part B

    Measured: Week 16

  34. Trough observed plasma concentration for deucravacitinib at Week 16

    Part B

    Measured: Week 16

  35. Proportion of participants with 75% improvement in PASI (PASI 75) over time

    LTE Period

    Measured: Up to 316 weeks

  36. Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time

    LTE Period

    Measured: Up to 316 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start23 Mar 2021
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion8 Sep 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04772079
Sponsor's protocol ID
IM011-126
Other IDs
2022-502519-13
Status last verified
Aug 2026
First submitted
24 Feb 2021
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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