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

NCT06869551 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IM011-1071
• Study Type: interventional
• Target: 60
• Locations: 11 countries
• Sites: 47

Brief Summary

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.

Conditions

Juvenile Psoriatic Arthritis

Keywords

Juvenile Psoriatic Arthritis (JPsA); Juvenile Idiopathic Arthritis (JIA); Pediatric PsA; Deucravacitinib; BMS-986165

Outcome Measures

Primary Outcomes (1)

• Time to first flare during the withdrawal period

  From week 16 up to week 42

Secondary Outcomes (17)

• Trough concentration at steady state (Cminss)

  At week 16

• Time-averaged steady-state concentration (Cavgss)

  At week 16

• Steady-state maximum observed concentration (Cmaxss)

  At week 16

• Number of participants with flare during the withdrawal period

  From week 16 up to week 42

• Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)

  At week 16 and week 42

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Deucravacitinib

Arm B

PLACEBO COMPARATOR

Drug: Deucravacitinib; Other: Placebo

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Arm A; Arm B

Placebo OTHER

Specified dose on specified days

Arm B

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (47)

Local Institution - 0038

Lancaster, California, 93534, United States

WITHDRAWN

Local Institution - 0020

Chicago, Illinois, 60611, United States

WITHDRAWN

Local Institution - 0023

Indianapolis, Indiana, 46202, United States

WITHDRAWN

Local Institution - 0059

North New Hyde Park, New York, 11040, United States

WITHDRAWN

Local Institution - 0065

Cincinnati, Ohio, 45229, United States

WITHDRAWN

Local Institution - 0066

Cleveland, Ohio, 44109, United States

WITHDRAWN

Local Institution - 0036

Austin, Texas, 78723, United States

WITHDRAWN

Local Institution - 0068

Fortaleza, Ceará, 60140-025, Brazil

NOT YET RECRUITING

Local Institution - 0032

Cuiabá, Mato Grosso, 78020-500, Brazil

WITHDRAWN

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-221, Brazil

RECRUITING

Local Institution - 0013

Curitiba, Paraná, 80250-060, Brazil

WITHDRAWN

Local Institution - 0072

Curitiba, Paraná, 80250-060, Brazil

NOT YET RECRUITING

Local Institution - 0007

Recife, Pernambuco, 50670-420, Brazil

NOT YET RECRUITING

Local Institution - 0033

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

WITHDRAWN

LMK Serviços Médicos S/S

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

RECRUITING

Local Institution - 0069

Xangri-lá, Rio Grande do Sul, 95588-000, Brazil

NOT YET RECRUITING

Local Institution - 0073

Vila Clementino, São Paulo-SP, 04038-002, Brazil

NOT YET RECRUITING

Local Institution - 0027

Rio de Janeiro, 21941-612, Brazil

NOT YET RECRUITING

Local Institution - 0047

São Paulo, 01223-001, Brazil

NOT YET RECRUITING

Local Institution - 0010

São Paulo, 04022-001, Brazil

WITHDRAWN

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Plovdiv, 4002, Bulgaria

RECRUITING

Local Institution - 0062

Sofia, 1797, Bulgaria

NOT YET RECRUITING

Local Institution - 0074

Beijing, Beijing Municipality, 100020, China

NOT YET RECRUITING

Local Institution - 0049

Beijing, Beijing Municipality, 100045, China

NOT YET RECRUITING

The Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400065, China

RECRUITING

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Childrens Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310057, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, 201102, China

RECRUITING

Fakultni nemocnice Olomouc

Olomouc, Olomoucký kraj, 779 00, Czechia

RECRUITING

Fakultni nemocnice v Motole

Prague, Praha 5, 150 06, Czechia

RECRUITING

Kinderklinik des Uni-Klinikums Erlangen

Erlangen, 91054, Germany

RECRUITING

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, 22081, Germany

RECRUITING

University of Naples Federico II

Naples, Campania, 80131, Italy

RECRUITING

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Tuscany, 50139, Italy

RECRUITING

Local Institution - 0017

San Juan, 00917, Puerto Rico

WITHDRAWN

Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

Cluj-Napoca, Cluj, 400177, Romania

RECRUITING

Local Institution - 0048

Iași, Iaşi, 700135, Romania

WITHDRAWN

Sc Medaudio-Optica Srl

Râmnicu Vâlcea, Vâlcea County, 247065, Romania

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Istanbul Universitesi Cerrahpasa

Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Local Institution - 0061

Ankara, 06170, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 0044

Ankara, 06230, Turkey (Türkiye)

NOT YET RECRUITING

Umraniye Training and Research Hospital

Istanbul, 34766, Turkey (Türkiye)

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): March 6, 2030
• Study Completion (Estimated): March 4, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

ES (3); IT (2); TU (4); PR (1); CN (8); DE (2); RO (3); BU (2); US (7); BR (13); CZ (2)