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Набира участници Фаза 3 NCT05923073

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Фаза 3 – широко изпитване преди одобрение
Заболявания: Crohn's Disease

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
Кой може да участва
Inclusion Criteria: * Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. * Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than or equal to \[\>=\] 30) * Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\>=) 6 (or \>=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0 * Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN) Exclusion Criteria: * Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery. * Participants must not have an abscess * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
Места на провеждане 15
Австралия (1)
Perth Children's Hospital
Nedlands
Белгия (1)
Universitair Ziekenhuis Brussel
Brussels
Бразилия (1)
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas
Канада (1)
Iwk Health Centre
Halifax , Nova Scotia
Франция (1)
CHU Amiens-Hopital Nord
Amiens
Израел (1)
Soroka University Medical Center
Beersheba
Италия (1)
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo
Япония (1)
Hirosaki University Hospital
Hirosaki
Нидерландия (1)
Erasmus Medisch Centrum
Rotterdam
Норвегия (1)
Akershus Universitetssykehus HF
Nordbyhagen
Полша (1)
Korczowski Bartosz Gabinet Lekarski
Rzeszów
Южна Корея (1)
Inje University Haeundae Paik Hospital
Busan
Испания (1)
Hosp Reina Sofia
Córdoba
Великобритания (1)
Royal Hospital for Sick Children
Glasgow
САЩ (1)
Cedars Sinai Medical Center
Los Angeles , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
13.03.2024
Крайна дата
12.07.2028
Регистрационен номер
NCT05923073
Източник
anzctr
Запитване за медицински туризъм

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