A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis

April 13, 2026 updated by: Bristol-Myers Squibb

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21941-612
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
      • São Paulo, Brazil, 04022-001
        • Withdrawn
        • Local Institution - 0010
      • São Paulo, Brazil, 01223-001
        • Not yet recruiting
        • Local Institution - 0047
        • Contact:
          • Site 0047
    • Ceará
      • Fortaleza, Ceará, Brazil, 60140-025
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil, 78020-500
        • Withdrawn
        • Local Institution - 0032
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Santa Casa de Misericordia de Belo Horizonte
        • Contact:
          • Filipe Maciel, Site 0030
          • Phone Number: +5531984545405
    • Paraná
      • Curitiba, Paraná, Brazil, 80250-060
        • Not yet recruiting
        • Local Institution - 0072
        • Contact:
          • Site 0072
      • Curitiba, Paraná, Brazil, 80250-060
        • Withdrawn
        • Local Institution - 0013
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-420
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Withdrawn
        • Local Institution - 0033
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • Recruiting
        • LMK Serviços Médicos S/S
        • Contact:
          • maria Picarelli, Site 0008
          • Phone Number: 5551999897478
      • Xangri-lá, Rio Grande do Sul, Brazil, 95588-000
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • São Paulo-SP
      • Vila Clementino, São Paulo-SP, Brazil, 04038-002
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
        • Contact:
          • Krastina Stefanova-Kelly, Site 0054
          • Phone Number: +359876324578
      • Sofia, Bulgaria, 1797
        • Not yet recruiting
        • Local Institution - 0062
        • Contact:
          • Site 0062
  • China
      • Shanghai, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:
          • Li Sun, Site 0050
          • Phone Number: 862164931122
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100045
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
      • Beijing, Beijing Municipality, China, 100020
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400065
        • Recruiting
        • The Children's Hospital of Chongqing Medical University
        • Contact:
          • Xuemei Tang, Site 0056
          • Phone Number: 13012352441
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangzhou Women And Children's Medical Center
        • Contact:
          • Ping Zeng, Site 0060
          • Phone Number: +8613160897678
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Childrens Hospital of Nanjing Medical University
        • Contact:
          • Haiguo Yu, Site 0052
          • Phone Number: 13770757631
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • sirui yang, Site 0053
          • Phone Number: 13500889222
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310057
        • Recruiting
        • The Children's Hospital of Zhejiang University School of Medicine
        • Contact:
          • Meiping Lu, Site 0051
          • Phone Number: 13685773988
  • Czechia
    • Olomoucký kraj
      • Olomouc, Olomoucký kraj, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc
        • Contact:
          • Katerina Bouchalova, Site 0003
          • Phone Number: +420602668887
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole
        • Contact:
          • Rudolf Horvath, Site 0002
          • Phone Number: 420727812317
  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Kinderklinik des Uni-Klinikums Erlangen
        • Contact:
          • Tobias Krickau, Site 0063
          • Phone Number: 091318533118
      • Hamburg, Germany, 22081
        • Recruiting
        • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
        • Contact:
          • Ivan Foeldvari, Site 0026
          • Phone Number: 00494020923698
  • Italy
    • Campania
      • Naples, Campania, Italy, 80131
        • Recruiting
        • University of Naples Federico II
        • Contact:
          • Roberta Naddei, Site 0005
          • Phone Number: 00393272022085
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Recruiting
        • Azienda Ospedaliera Universitaria Meyer IRCCS
        • Contact:
          • Gabriele Simonini, Site 0004
          • Phone Number: +393297973141
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Withdrawn
        • Local Institution - 0017
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400177
        • Recruiting
        • Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca
        • Contact:
          • Mihaela Sparchez, Site 0067
          • Phone Number: +40723400453
    • Iaşi
      • Iași, Iaşi, Romania, 700135
        • Withdrawn
        • Local Institution - 0048
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Romania, 247065
        • Recruiting
        • Sc Medaudio-Optica SRL
        • Contact:
          • RAZVAN IONITESCU, Site 0040
          • Phone Number: 0040722557297
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politècnic La Fe
        • Contact:
          • LUCIA LACRUZ PEREZ, Site 0042
          • Phone Number: +34961244792
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Mireia Corbeto, Site 0046
          • Phone Number: 667517630
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • Alina Lucica Boteanu, Site 0041
          • Phone Number: +34913368571
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06170
        • Not yet recruiting
        • Local Institution - 0061
        • Contact:
          • Site 0061
      • Ankara, Turkey (Türkiye), 06230
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
      • Istanbul, Turkey (Türkiye), 34766
        • Recruiting
        • Ümraniye Training and Research Hospital
        • Contact:
          • Betul Sozeri, Site 0045
          • Phone Number: +905327629003
    • Istanbul
      • Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa
        • Contact:
          • Ozgur Kasapcopur, Site 0043
          • Phone Number: +905322129111
  • United States
    • California
      • Lancaster, California, United States, 93534
        • Withdrawn
        • Local Institution - 0038
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Local Institution - 0020
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Withdrawn
        • Local Institution - 0023
    • New York
      • North New Hyde Park, New York, United States, 11040
        • Withdrawn
        • Local Institution - 0059
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Withdrawn
        • Local Institution - 0065
      • Cleveland, Ohio, United States, 44109
        • Withdrawn
        • Local Institution - 0066
    • Texas
      • Austin, Texas, United States, 78723
        • Withdrawn
        • Local Institution - 0036

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants must have been diagnosed with Juvenile Psoriatic Arthritis (JPsA).
  • Participants must have at least three joints that are affected by arthritis.
  • Participants must have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems.

Exclusion Criteria

  • Participants must not have been diagnosed with JPsA before 5 years of age.
  • Participants must not have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA,
  • Participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months.
  • 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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Deucravacitinib
Specified dose on specified days
Placebo Comparator: Arm B
Drug: Deucravacitinib
Specified dose on specified days
Other: Placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first flare during the withdrawal period
Time Frame: From week 16 up to week 42
From week 16 up to week 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Trough concentration at steady state (Cminss)
Time Frame: At week 16
At week 16
Time-averaged steady-state concentration (Cavgss)
Time Frame: At week 16
At week 16
Steady-state maximum observed concentration (Cmaxss)
Time Frame: At week 16
At week 16
Number of participants with flare during the withdrawal period
Time Frame: From week 16 up to week 42
From week 16 up to week 42
Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)
Time Frame: At week 16 and week 42
At week 16 and week 42
Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Pedi Core Criteria
Time Frame: At week 16 and week 42
At week 16 and week 42
Number of participants achieving low disease activity (Juvenile arthritis disease activity 71-joint score based on C-reactive protein (JADAS71-CRP) score: for oligoarthritis 1.1 to 2; for polyarthritis 1.1 to 3.8)
Time Frame: At week 16 and week 42
At week 16 and week 42
Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)
Time Frame: At week 16 and week 42
At week 16 and week 42
Number of participants attaining clinical remission for at least 6 consecutive months
Time Frame: At week 42
At week 42
Number of participants achieving psoriasis area and severity index (PASI) 75
Time Frame: At week 42
At week 42
Number of participants for each assessment who evaluate palatability scale as ≥ 3 (good or better), swallowability scale as ≤ 4 (neutral or easier), and taste scales (Sweetness, Bitterness, Flavor, and Overall Taste) as "None" or "Weak"
Time Frame: At week 16
At week 16
Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using ACR Pedi 30
Time Frame: At week 16
At week 16
Number of participants with adverse events (AEs)
Time Frame: Up to week 42
Up to week 42
Number of participants with adverse event of special interest (AESIs)
Time Frame: Up to week 42
Up to week 42
Number of participants with AEs leading to discontinuation
Time Frame: Up to week 42
Up to week 42
Number of participants with serious adverse events (SAEs)
Time Frame: Up to week 42
Up to week 42
Number of participants with Uveitis
Time Frame: Up to week 42
Up to week 42

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • 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)

March 13, 2025

Primary Completion (Estimated)

March 6, 2030

Study Completion (Estimated)

March 4, 2031

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-1071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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