Език: EN EN
← Назад към резултатите
Набира участници Фаза 2/3 NCT05076175

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

Фаза 2/3 – комбинирано изпитване
Заболявания: Colitis, Ulcerative

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.
Кой може да участва
Inclusion Criteria * Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit * Evidence of UC extending beyond the rectum, as determined by baseline endoscopy * Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy Exclusion Criteria * Diagnosis of Crohn's disease or indeterminate colitis * Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool * Apheresis within 2 weeks of randomization * History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis * Other protocol-defined inclusion/exclusion criteria apply
Места на провеждане 13
Австралия (1)
The Children's Hospital at Westmead
Westmead , New South Wales
Shoma Dutt, Site 0094
Белгия (1)
Local Institution - 0076
Brussels , Bruxelles-Capitale, Région de
WITHDRAWN
Канада (1)
Local Institution - 0083
Hamilton , Ontario
WITHDRAWN
Франция (1)
CHU de Toulouse - Hôpital des Enfants
Toulouse , Haute-Garonne
EMMANUEL MAS, Site 0058
Германия (1)
Local Institution - 0032
München , Bavaria
COMPLETED
Израел (1)
Schneider Children's Medical Center
Petah Tikva , Central District
Dror Shouval, Site 0020
Япония (1)
Aichi Children's Health and Medical Center
Ōbu , Aichi-ken
Naomi Iwata, Site 0025
Полша (1)
Local Institution - 0084
Krakow , Lesser Poland Voivodeship
WITHDRAWN
Puerto Rico (1)
Clinical Research Puerto Rico
San Juan
Antonio Del Valle-Segarra, Site 0098
Russia (1)
Local Institution
Moscow
WITHDRAWN
Испания (1)
Local Institution - 0048
Badalona , Barcelona [Barcelona]
COMPLETED
Великобритания (1)
Birmingham Children's Hospital
Birmingham , England
Rafeeq Muhammed, Site 0054
САЩ (1)
Local Institution - 0041
Phoenix , Arizona
WITHDRAWN
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
30.05.2022
Крайна дата
14.08.2031
Регистрационен номер
NCT05076175
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.