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Набира участници Фаза 3 NCT04772079

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Plaque Psoriasis

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.
Кой може да участва
Inclusion Criteria * Males and females aged 12 to \<18 years for Cohort 1. Males and females aged 4 to \<12 years for Cohort 2. * Plaque psoriasis for at least 6 months. * Moderate to severe disease. * Candidate for phototherapy or systemic therapy. * Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period. Exclusion Criteria * Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing ≤ 18.0 kg at screening for Cohort 2 (age 4 to \< 12 years), Part A and Part B. * Other forms of psoriasis. * History of recent infection. * Prior exposure to deucravacitinib (BMS-986165) or active comparator. * Evidence of active TB for LTE period. * Other protocol-defined inclusion/exclusion criteria apply.
Места на провеждане 13
Argentina (1)
Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires , Buenos Aires
Paula Luna, Site 0042
Австралия (1)
The Skin Hospital
Darlinghurst , New South Wales
John Frew, Site 0020
Бразилия (1)
Centro de Pesquisas da Clínica IBIS
Salvador , Estado de Bahia
Gleison Duarte, Site 0069
Канада (1)
Local Institution - 0010
Calgary , Alberta
COMPLETED
Франция (1)
Centre Hospitalier de Calais
Calais
Christopher COSSART, Site 0090
Германия (1)
Universitätsklinikum Münster
Münster , North Rhine-Westphalia
Nina Magnolo, Site 0077
Япония (1)
Nagoya City University Hospital
Nagoya , Aichi-ken
Akimichi Morita, Site 0033
Mexico (1)
Crea de Guadalajara
Guadalajara , Jalisco
Gabriel Vega Cornejo, Site 0054
Полша (1)
Local Institution - 0011
Krakow
COMPLETED
Румъния (1)
Local Institution - 0080
Bucharest , Bucharest
WITHDRAWN
Южна Корея (1)
Local Institution - 0048
Seoul , Seoul-teukbyeolsi [Seoul]
COMPLETED
Испания (1)
Hospital General Universitario de Alicante-Dermatology
Alicante
laura berbegal, Site 0017
Великобритания (1)
Mounts Bay Medical
Connor Downs
Richard Burkimsher, Site 0019
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
4 Years
Максимална възраст
18 Years
Здрави доброволци
Не
Начална дата
23.03.2021
Крайна дата
08.09.2033
Регистрационен номер
NCT04772079
Източник
anzctr
Запитване за медицински туризъм

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