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Набира участници Фаза 3 NCT07196748

A Protocol of Icotrokinra Therapy in Adult and Adolescent 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 protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
Кой може да участва
Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC * Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy * An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy * Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0) * Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests * Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocol Exclusion Criteria: * Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study * Presence of a stoma * Presence or history of a fistula * Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline * History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
Места на провеждане 26
Argentina (1)
GEDYT
AAI
Австралия (1)
Monash Medical Centre
Clayton
Белгия (1)
CHU Saint-Pierre
Brussels
Бразилия (1)
Hospital das Clinicas do HC/UFMG
Belo Horizonte
Канада (1)
South Edmonton Gastroenterology Research Clinic
Edmonton , Alberta
Китай (1)
China Japan Friendship Hospital
Beijing
Чехия (1)
Fakultni nemocnice Brno
Brno
Франция (1)
Centre Hospitalier de la Cote Basque
Bayonne
Германия (1)
Universitaetsklinikum der RWTH Aachen
Aachen
Гърция (1)
Evangelismos S A
Athens
Унгария (1)
Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz
Békéscsaba
Индия (1)
Mazumdar Shaw Medical Centre - Narayana Hrudayalaya Limited
Bangalore
Израел (1)
Haemek Medical Center
Afula
Италия (1)
Azienda Ospedaliero Universitaria Careggi
Florence
Япония (1)
Juntendo University Hospital Urayasu
Chiba
Malaysia (1)
Hospital Sultanah Bahiyah
Alor Star
Нидерландия (1)
Vrije Universiteit Medisch Centrum
Amsterdam
Полша (1)
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz
Румъния (1)
S C Delta Health Care S R L
Bucharest
Южна Корея (1)
Inje University Haeundae Paik Hospital
Busan
Испания (1)
Hosp. Clinic de Barcelona
Barcelona
Швеция (1)
Alingsas lasarett
Allingsas
Taiwan (1)
Changhua Christian Hospital
Changhua
Турция (1)
Hacettepe University Medical Faculty
Ankara
Великобритания (1)
Addenbrooke's Hospital
Cambridge
САЩ (1)
AZ Gastro Care
Chandler , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Здрави доброволци
Не
Начална дата
01.10.2025
Крайна дата
13.01.2032
Регистрационен номер
NCT07196748
Източник
anzctr
Запитване за медицински туризъм

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