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Активно (без набиране) Фаза 3 NCT06260163

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Colitis, Ulcerative

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
Кой може да участва
Inclusion Criteria: * Weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening * A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC. * Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy * Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator * Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids Exclusion Criteria: * Have UC limited to the rectum only or to less than (\<) 20 centimeter of the colon * Presence of a stoma * Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline * Have severe colitis or have evidence of Crohn's Disease (CD)
Места на провеждане 12
Австралия (1)
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands
Белгия (1)
CHU Charleroi Chimay
Charleroi
Китай (1)
Capital Center For Children's health Capital Medical University
Beijing
Дания (1)
Aarhus Universitetshospital
Aarhus N
Франция (1)
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron
Италия (1)
ASST Papa Giovanni XXIII Bergamo
Bergamo
Япония (1)
Tokyo Metropolitan Children's Medical Center
Fuchū
Норвегия (1)
Akershus Universitetssykehus
Lørenskog
Полша (1)
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk
Испания (1)
Hosp. Infantil Univ. Nino Jesus
Madrid
Турция (1)
Gazi University Medical Faculty
Ankara
САЩ (1)
Children's Hospital Oakland
Oakland , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
19.01.2024
Крайна дата
14.08.2028
Регистрационен номер
NCT06260163
Източник
anzctr
Запитване за медицински туризъм

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