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Набира участници Фаза 3 NCT07158242

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Moderately to Severely Active Ulcerative Colitis

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).
Кой може да участва
Inclusion Criteria: * Bodyweight \>= 10 kilogram (kg) * Confirmed diagnosis of UC * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol Exclusion Criteria: * Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD) * Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease * Presence of an ostomy or ileoanal pouch * Current diagnosis or suspicion of primary sclerosing cholangitis * Any major surgery within 6 weeks prior to screening or a major planned surgery during the study * Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)
Интервенции
Afimkibart
DRUG
Места на провеждане 9
Taiwan (1)
National Taiwan University Hospital
Taipei
Тайланд (3)
Chulalongkorn University
Bangkok
Siriraj Hospital
Bangkok
Ramathibodi Hospital
Bangkok
Великобритания (3)
Birmingham Children's Hospital
Birmingham
Addenbrooke's Hospital
Cambridge
Sheffield Childrens Hospital
Sheffield
САЩ (2)
Children's Healthcare of Atlanta
Atlanta , Georgia
NYU School of Medicine
New York , New York
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
15.04.2026
Крайна дата
31.03.2031
Регистрационен номер
NCT07158242
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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