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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Deucravacitinib
  Specified dose on specified days
• Другое Placebo
  Specified dose on specified days

Первичные конечные точки

• Time to first flare during the withdrawal period [Срок оценки: From week 16 up to week 42]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 12 центров

• 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
• … и ещё 4 центра

Китай · 8 центров

• Local Institution - 0074 — Пекин
• Local Institution - 0049 — Пекин
• The Children's Hospital of Chongqing Medical University — Чунцин
• Guangzhou Women and Children's Medical Center — Гуанчжоу
• Childrens Hospital of Nanjing Medical University — Нанкин
• The First Hospital of Jilin University — Changchun
• The Children's Hospital of Zhejiang University School of Medicine — Ханчжоу
• Children's Hospital of Fudan University — Шанхай

США · 7 центров

• 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 центра

• Istanbul Universitesi Cerrahpasa — Istanbul- Fatih
• Local Institution - 0061 — Ankara
• Local Institution - 0044 — Ankara
• Umraniye Training and Research Hospital — Istanbul

Болгария · 3 центра

• University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD — Plovdiv
• Local Institution - 0069 — Sofia
• Local Institution - 0062 — Sofia

Румыния · 3 центра

• Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca — Cluj-Napoca
• Local Institution - 0048 — Iași
• Sc Medaudio-Optica Srl — Râmnicu Vâlcea

Испания · 3 центра

• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitari i Politecnic La Fe — Valencia

Чехия · 2 центра

• Fakultni nemocnice Olomouc — Olomouc
• Fakultni nemocnice v Motole — Prague

Германия · 2 центра

• Kinderklinik des Uni-Klinikums Erlangen — Erlangen
• Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari — Hamburg

Италия · 2 центра

• University of Naples Federico II — Naples
• Azienda Ospedaliera Universitaria Meyer IRCCS — Florence

Пуэрто-Рико · 1 центр

• Local Institution - 0017 — San Juan

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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