A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric 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

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric 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 pediatric 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 pediatric participants with psoriasis who have completed Parts A or B of the study.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Deucravacitinib; Other: Placebo matching deucravacitinib

• Study Type: Interventional
• Enrollment (Estimated): 153
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1012
    • Recruiting
    • Conexa Investigación Clínica S.A.
    • Contact: Pablo Gonzalez, Site 0058; Phone Number: +5491154140381
  • Buenos Aires, Argentina, C1056ABI
    • Recruiting
    • Centro de Investigaciones Metabólicas (CINME)
    • Contact: Maria Laura Galimberti, Site 0044; Phone Number: 5491154583202
  • CABA, Argentina, 1199
    • Recruiting
    • Hospital Italiano de Buenos Aires
    • Contact: Maria Angles, Site 0043; Phone Number: +5491168360026
  • Córdoba, Argentina, 5004
    • Recruiting
    • Consultora Integral de Salud
    • Contact: Veronica Savio, Site 0089; Phone Number: +5493515337844
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
      • Recruiting
      • Instituto de Neumonologia Y Dermatologia
      • Contact: Paula Luna, Site 0042; Phone Number: 5491145404644
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DKG
      • Recruiting
      • Psoriahue
      • Contact: Gabriel Magariños, Site 0045; Phone Number: 5401148238755
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • The Skin Hospital
      • Contact: John Frew, Site 0020; Phone Number: 0280381044
    • Westmead, New South Wales, Australia, 2145
      • Withdrawn
      • Local Institution - 0002
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Queensland Children's Hospital
      • Contact: Tania Zappala, Site 0072; Phone Number: 30681111
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Veracity Clinical Research
      • Contact: Lynda Spelman, Site 0003; Phone Number: +61730391311
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health
      • Contact: Francis Lai, Site 0046; Phone Number: 0395936666
    • Melbourne, Victoria, Australia, 3995
      • Completed
      • Local Institution - 0001
• Brazil
  • Rio de Janeiro, Brazil, 22470-220
    • Not yet recruiting
    • Local Institution - 0083
    • Contact: Site 0083
  • São Paulo, Brazil, 05403-000
    • Withdrawn
    • Local Institution - 0067
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41820-020
      • Recruiting
      • Centro de Pesquisas da Clínica IBIS
      • Contact: Gleison Duarte, Site 0069; Phone Number: +557199628-2914
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90560032
      • Recruiting
      • Hospital Moinhos de Vento
      • Contact: André Carvalho, Site 0070; Phone Number: +5551993785952
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Recruiting
      • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
      • Contact: Cacilda da Silva Souza, Site 0064; Phone Number: 551636022302
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Completed
      • Local Institution - 0010
    • Edmonton, Alberta, Canada, T6G 1C3
      • Recruiting
      • Alberta Dermasurgery Centre
      • Contact: Jaggi Rao, Site 0037; Phone Number: 587-487-0187
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Withdrawn
      • Local Institution - 0039
    • Markham, Ontario, Canada, L3P 1X3
      • Recruiting
      • Lynderm Research Inc.
      • Contact: Charles Lynde, Site 0008; Phone Number: 9054718011
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Rebecca Levy, Site 0050; Phone Number: 4168137654x428232
• France
  • Calais, France, 62107
    • Recruiting
    • Centre hospitalier de Calais
    • Contact: Christopher COSSART, Site 0090; Phone Number: 0366256173
  • Dijon, France, 21000
    • Recruiting
    • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
    • Contact: Bertille Bonniaud, Site 0028; Phone Number: 33380293336
  • Nice, France, 06202
    • Recruiting
    • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
    • Contact: Thomas Hubiche, Site 0012; Phone Number: +33492036667
  • Paris, France, 75019
    • Completed
    • Local Institution - 0021
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitaetsmedizin Berlin - Campus Mitte
    • Contact: Sonja Molin, Site 0076; Phone Number: 030450618343
  • Hamburg, Germany, 22149
    • Recruiting
    • Kath. Kinderkrankenhaus Wilhelmstift
    • Contact: Peter Hoeger, Site 0074; Phone Number: 00494067377202
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • Universitätsklinikum Münster
      • Contact: Nina Magnolo, Site 0077; Phone Number: 0049-251-8356558
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Recruiting
      • Universitätsmedizin Johannes Gutenberg Universität Mainz
      • Contact: Petra Staubach-Renz, Site 0075; Phone Number: +496131175732
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Universitaetsklinikum Carl Gustav Carus Dresden
      • Contact: Susanne Abraham, Site 0073; Phone Number: +493514583401
• Japan
  • Osaka, Japan, 550-0006
    • Recruiting
    • Nippon Life Hospital
    • Contact: Mari Higashiyama, Site 0035; Phone Number: +81664433446
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Recruiting
      • Nagoya City University Hospital
      • Contact: Akimichi Morita, Site 0033; Phone Number: +81-52-851-5511
  • Fukuoka
    • Fukuoka, Jonan-Ku, Fukuoka, Japan, 814-0180
      • Recruiting
      • Fukuoka University Hospital
      • Contact: Shinichi Imafuku, Site 0032; Phone Number: 81928011011
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Withdrawn
      • Local Institution - 0040
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Recruiting
      • Mie University Hospital
      • Contact: Keiichi Yamanaka, Site 0038; Phone Number: 81-59-232-1111
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Recruiting
      • Teikyo University Hospital
      • Contact: Yayoi Tada, Site 0034; Phone Number: 81339641211
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Recruiting
      • Tokyo Medical University Hospital
      • Contact: Yukari Okubo, Site 0041; Phone Number: 81-3-3342-6111
• Mexico
  • Veracruz, Mexico, 91910
    • Recruiting
    • Arké SMO S.A de C.V
    • Contact: Claudia Bernabe del Rio, Site 0053; Phone Number: +522299314102
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • Recruiting
      • Crea de Guadalajara
      • Contact: Gabriel Vega Cornejo, Site 0054; Phone Number: 3314172229
    • Guadalajara, Jalisco, Mexico, 44638
      • Recruiting
      • Grupo Clínico CATEI S.C.
      • Contact: Delfina Villanueva Quintero, Site 0057; Phone Number: 3331151992
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03100
      • Recruiting
      • RM Pharma Specialists
      • Contact: Zamira Barragan-Estudillo, Site 0052; Phone Number: 525565501629
• Poland
  • Krakow, Poland, 30-438
    • Completed
    • Local Institution - 0011
  • Lodz, Poland, 90-436
    • Recruiting
    • Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
    • Contact: Joanna Narbutt, Site 0006; Phone Number: + 48 603756804
  • Warsaw, Poland, 02-507
    • Recruiting
    • Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii
    • Contact: Irena Walecka Herniczek, Site 0004; Phone Number: 48603389394
  • Wroclaw, Poland, 51-620
    • Recruiting
    • WroMedica
    • Contact: Wojciech Baran, Site 0005; Phone Number: +48 604058690
• Romania
  • Bucharest, Romania, 020528
    • Recruiting
    • Lotus-Med Tunari
    • Contact: Adelina-Maria Sendrea, Site 0087; Phone Number: 0040760930352
  • Iași, Romania, 700309
    • Recruiting
    • Spitalul clinic de urgenta pentru copii Sf. Maria
    • Contact: Monica Cozorici, Site 0079; Phone Number: 0740303215
  • Târgu Mureş, Romania, 540342
    • Recruiting
    • Spitalul Clinic Judetean Mures
    • Contact: Silviu Morariu, Site 0078; Phone Number: +40744757246
  • București
    • Bucharest, București, Romania, 012292
      • Withdrawn
      • Local Institution - 0080
    • Bucharest, București, Romania, 020762
      • Withdrawn
      • Local Institution - 0088
    • Bucharest, București, Romania, 30463
      • Recruiting
      • CCBR Clinical Research
      • Contact: Mara Mihai, Site 0082; Phone Number: 0040743364164
    • Bucharest, București, Romania, 020125
      • Withdrawn
      • Local Institution - 0081
• South Korea
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
      • Recruiting
      • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Contact: Chul Hwan Bang, Site 0059; Phone Number: +82222581395
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02447
      • Completed
      • Local Institution - 0048
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
      • Completed
      • Local Institution - 0047
• Spain
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Universitario de Alicante-Dermatology
    • Contact: laura berbegal, Site 0017; Phone Number: +34965913723
  • Barakaldo, Spain, 48903
    • Recruiting
    • OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology
    • Contact: Marta Mendieta Eckert, Site 0026; Phone Number: 946006149
  • Esplugues de Llobregat, Spain, 08950
    • Recruiting
    • Hospital Sant Joan de Déu-URC Dermatology
    • Contact: Asuncion Vicente Villa, Site 0014; Phone Number: 936009733(ext.70034)
  • Las Palmas de GC, Spain, 35019
    • Recruiting
    • Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
    • Contact: ALICIA GONZALEZ QUESADA, Site 0016; Phone Number: +34928450659
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre-DERMATOLOGY
    • Contact: Raquel Rivera-Diaz, Site 0027; Phone Number: 34917792260
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz-UCICEC/DERMA
    • Contact: Raul de Lucas Laguna, Site 0022; Phone Number: 34917277231
• United Kingdom
  • Connor Downs, United Kingdom, TR27 5DT
    • Recruiting
    • Mounts Bay Medical
    • Contact: Richard Burkimsher, Site 0019; Phone Number: 01736 805460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 active comparator.
• Evidence of active TB for LTE period.
• Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo matching deucravacitinib; Specified dose on specified days
Experimental: Active treatment deucravacitinib standard dose	Drug: Deucravacitinib; Specified dose on specified days
Experimental: Active treatment deucravacitinib half-standard dose	Drug: Deucravacitinib; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2	Part A	Week 2
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2	Part A	Week 2
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2	Part A	Week 2
Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16	Part B	Week 16
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	Week 16
Incidence of Adverse Events (AEs)	Long-term extension (LTE) Period	Up to 316 weeks
Incidence of serious adverse events (SAEs)	LTE Period	Up to 316 weeks
Monitoring of growth: Body weight	LTE Period	Up to 316 weeks
Monitoring of growth: Height	LTE Period	Up to 316 weeks
Monitoring of growth: Tanner staging (sexual maturation)	LTE Period	Up to 316 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)	Part A and Part B	Up to 424 days
Incidence of serious adverse events (SAEs)	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests	Part A and Part B	Up to 410 days
Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests	Part A and Part B	Up to 42 days
Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests	Part A and Part B	Up to 42 days
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests	Part A and Part B	Up to 368 days
Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests	Part A and Part B	Up to 368 days
Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests	Part A and Part B	Up to 368 days
Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in lymphocyte subsets and function	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in cytokine levels	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in physical examination findings	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in vital signs: Body temperature	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure	Part A and Part B	Up to 466 days
Incidence of clinically significant changes in vital signs: Heart rate	Part A and Part B	Up to 466 days
Monitoring of growth: Body weight	Part A and Part B	Up to 466 days
Monitoring of growth: Height	Part A and Part B	Up to 466 days
Monitoring of growth: Tanner staging (sexual maturation)	Part A and Part B	Up to 466 days
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	Week 16
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	Week 16
Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo	Part B	Week 16
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
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	Week 16
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	Week 16
Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline	Part B ACR Pedi 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	Week 16
Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo	Part B	Week 16
Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16	Part B	Week 16
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16	Part B	Week 16
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16	Part B	Week 16
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16	Part B	Week 16
Proportion of participants with 75% improvement in PASI (PASI 75) over time	LTE Period	Up to 316 weeks
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	Up to 316 weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): September 8, 2033

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis; Pediatric; Plaque Psoriasis; Clinical trial; Deucravacitinib; BMS-986165; Adolescent Psoriasis; Pediatric Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; deucravacitinib
• Other Study ID Numbers: IM011-126; 2019-004879-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No