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Recruiting NCT06869551

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

Phase III Interventional Juvenile Psoriatic Arthritis

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deucravacitinib, Placebo.
Who it may be relevant to
Registry conditions: Juvenile Psoriatic Arthritis. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Brazil, Bulgaria, China, Czechia +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Deucravacitinib
    Specified dose on specified days
  • Other Placebo
    Specified dose on specified days

Primary outcome measures

  • Time to first flare during the withdrawal period [Time frame: From week 16 up to week 42]
Secondary outcome measures (12)
  • Trough concentration at steady state (Cminss) [Time frame: At week 16]
  • Time-averaged steady-state concentration (Cavgss) [Time frame: At week 16]
  • Steady-state maximum observed concentration (Cmaxss) [Time frame: At week 16]
  • Number of participants with flare during the withdrawal period [Time frame: From week 16 up to 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: Through week 16 and up to week 42]
  • Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1) [Time frame: Through week 16 and up to week 42]
  • Number of participants attaining clinical remission for at least 6 consecutive months [Time frame: At week 42]
  • Number of participants achieving psoriasis area and severity index (PASI) 75 [Time frame: At week 42]
  • Number of participants with adverse events (AEs) [Time frame: Up to week 42]
  • Number of participants with adverse event of special interest (AESIs) [Time frame: Up to week 42]
  • Number of participants with AEs leading to discontinuation [Time frame: Up to week 42]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to week 42]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 12 centers
  • Centro de Oncologia Leonardo Da Vinci - ATO Terapias — Fortaleza
  • Local Institution - 0032 — Cuiabá
  • Santa Casa de Misericordia de Belo Horizonte — Belo Horizonte
  • Local Institution - 0013 — Curitiba
  • Local Institution - 0072 — Curitiba
  • Hospital Das Clinicas Ufpe — Recife
  • Local Institution - 0033 — Porto Alegre
  • LMK Serviços Médicos S/S — Porto Alegre
  • … and 4 more centers
China · 8 centers
  • Local Institution - 0074 — Beijing
  • Local Institution - 0049 — Beijing
  • The Children's Hospital of Chongqing Medical University — Chongqing
  • Guangzhou Women and Children's Medical Center — Guangzhou
  • Childrens Hospital of Nanjing Medical University — Nanjing
  • The First Hospital of Jilin University — Changchun
  • The Children's Hospital of Zhejiang University School of Medicine — Hangzhou
  • Children's Hospital of Fudan University — Shanghai
United States · 7 centers
  • Local Institution - 0038 — Lancaster
  • Local Institution - 0020 — Chicago
  • Local Institution - 0023 — Indianapolis
  • Local Institution - 0059 — North New Hyde Park
  • Local Institution - 0065 — Cincinnati
  • Local Institution - 0066 — Cleveland
  • Local Institution - 0036 — Austin
Turkey (Türkiye) · 4 centers
  • Istanbul Universitesi Cerrahpasa — Istanbul- Fatih
  • Local Institution - 0061 — Ankara
  • Local Institution - 0044 — Ankara
  • Umraniye Training and Research Hospital — Istanbul
Bulgaria · 3 centers
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD — Plovdiv
  • Local Institution - 0069 — Sofia
  • Local Institution - 0062 — Sofia
Romania · 3 centers
  • Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca — Cluj-Napoca
  • Local Institution - 0048 — Iași
  • Sc Medaudio-Optica Srl — Râmnicu Vâlcea
Spain · 3 centers
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Hospital Universitario Ramón y Cajal — Madrid
  • Hospital Universitari i Politecnic La Fe — Valencia
Czechia · 2 centers
  • Fakultni nemocnice Olomouc — Olomouc
  • Fakultni nemocnice v Motole — Prague
Germany · 2 centers
  • Kinderklinik des Uni-Klinikums Erlangen — Erlangen
  • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari — Hamburg
Italy · 2 centers
  • University of Naples Federico II — Naples
  • Azienda Ospedaliera Universitaria Meyer IRCCS — Florence
Puerto Rico · 1 center
  • Local Institution - 0017 — San Juan

Identifiers

NCT: NCT06869551 · IM011-1071 · 2024-517262-41 · U1111-1311-9059

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗