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

September 24, 2025 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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 Investigacion Clinica 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
        • Universitatsklinikum Munster
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
Time Frame: Week 2
Part A
Week 2
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
Time Frame: Week 2
Part A
Week 2
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2
Time Frame: 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
Time Frame: 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
Time Frame: Week 16
Part B
Week 16
Incidence of Adverse Events (AEs)
Time Frame: Up to 316 weeks
Long-term extension (LTE) Period
Up to 316 weeks
Incidence of serious adverse events (SAEs)
Time Frame: Up to 316 weeks
LTE Period
Up to 316 weeks
Monitoring of growth: Body weight
Time Frame: Up to 316 weeks
LTE Period
Up to 316 weeks
Monitoring of growth: Height
Time Frame: Up to 316 weeks
LTE Period
Up to 316 weeks
Monitoring of growth: Tanner staging (sexual maturation)
Time Frame: Up to 316 weeks
LTE Period
Up to 316 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 424 days
Part A and Part B
Up to 424 days
Incidence of serious adverse events (SAEs)
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests
Time Frame: Up to 410 days
Part A and Part B
Up to 410 days
Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests
Time Frame: Up to 42 days
Part A and Part B
Up to 42 days
Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests
Time Frame: Up to 42 days
Part A and Part B
Up to 42 days
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Time Frame: Up to 368 days
Part A and Part B
Up to 368 days
Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests
Time Frame: Up to 368 days
Part A and Part B
Up to 368 days
Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests
Time Frame: Up to 368 days
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
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in lymphocyte subsets and function
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in cytokine levels
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in physical examination findings
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Monitoring of growth: Body weight
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Monitoring of growth: Height
Time Frame: Up to 466 days
Part A and Part B
Up to 466 days
Monitoring of growth: Tanner staging (sexual maturation)
Time Frame: Up to 466 days
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
Time Frame: Week 16
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
Time Frame: Week 16
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
Time Frame: Week 16
Part B
Week 16
Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo
Time Frame: Week 16
Part B
Week 16
Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo
Time Frame: Week 16
Part B
Week 16
Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo
Time Frame: Week 16
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
Time Frame: Week 16
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
Time Frame: Week 16
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
Time Frame: Week 16

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
Time Frame: Week 16
Part B
Week 16
Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16
Time Frame: Week 16
Part B
Week 16
Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16
Time Frame: Week 16
Part B
Week 16
Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16
Time Frame: Week 16
Part B
Week 16
Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16
Time Frame: Week 16
Part B
Week 16
Proportion of participants with 75% improvement in PASI (PASI 75) over time
Time Frame: Up to 316 weeks
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
Time Frame: Up to 316 weeks
LTE Period
Up to 316 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

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Dietary Supplements

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