RecruitingPhase 3NCT06869551

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

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


Sponsor

Bristol-Myers Squibb

Enrollment

60 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

DRUGDeucravacitinib

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days


Locations(47)

Local Institution - 0038

Lancaster, California, United States

Local Institution - 0020

Chicago, Illinois, United States

Local Institution - 0023

Indianapolis, Indiana, United States

Local Institution - 0059

North New Hyde Park, New York, United States

Local Institution - 0065

Cincinnati, Ohio, United States

Local Institution - 0066

Cleveland, Ohio, United States

Local Institution - 0036

Austin, Texas, United States

Local Institution - 0068

Fortaleza, Ceará, Brazil

Local Institution - 0032

Cuiabá, Mato Grosso, Brazil

Local Institution - 0030

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0013

Curitiba, Paraná, Brazil

Local Institution - 0072

Curitiba, Paraná, Brazil

Local Institution - 0007

Recife, Pernambuco, Brazil

Local Institution - 0033

Porto Alegre, Rio Grande do Sul, Brazil

LMK Serviços Médicos S/S

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0069

Xangri-lá, Rio Grande do Sul, Brazil

Local Institution - 0073

Vila Clementino, São Paulo-SP, Brazil

Local Institution - 0027

Rio de Janeiro, Brazil

Local Institution - 0047

São Paulo, Brazil

Local Institution - 0010

São Paulo, Brazil

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

Plovdiv, Bulgaria

Local Institution - 0062

Sofia, Bulgaria

Local Institution - 0074

Beijing, Beijing Municipality, China

Local Institution - 0049

Beijing, Beijing Municipality, China

The Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Childrens Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Children's Hospital of Fudan University

Shanghai, China

Fakultni nemocnice Olomouc

Olomouc, Olomoucký kraj, Czechia

Fakultni nemocnice v Motole

Prague, Praha 5, Czechia

Kinderklinik des Uni-Klinikums Erlangen

Erlangen, Germany

Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

Hamburg, Germany

University of Naples Federico II

Naples, Campania, Italy

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, Tuscany, Italy

Local Institution - 0017

San Juan, Puerto Rico

Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Local Institution - 0048

Iași, Iaşi, Romania

Sc Medaudio-Optica Srl

Râmnicu Vâlcea, Vâlcea County, Romania

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Istanbul Universitesi Cerrahpasa

Istanbul- Fatih, Istanbul, Turkey (Türkiye)

Local Institution - 0061

Ankara, Turkey (Türkiye)

Local Institution - 0044

Ankara, Turkey (Türkiye)

Umraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

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NCT06869551


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