Идёт набор NCT07196748

A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis

Фаза III С лечением Colitis, Ulcerative

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Icotrokinra, Placebo.
Кому может быть актуально: Состояния в реестре: Colitis, Ulcerative. Базовые параметры: от 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Бельгия, Бразилия +23
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

Обзор

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).

Вмешательства

Препарат Icotrokinra
Icotrokinra tablet will be administered orally.
Препарат Placebo
Placebo tablet will be administered orally.

Первичные конечные точки

Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12 [Срок оценки: At Week I-12]
DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40 [Срок оценки: At Week M-40]
Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40 [Срок оценки: At Week M-40]

Вторичные конечные точки (12)

DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI) at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Fatigue Response at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-4 [Срок оценки: At Week I-4]
DB Induction Study: Percentage of Adult Participants in Endoscopic Remission at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with No Bowel Urgency at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with No Abdominal Pain at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with No Bowel Incontinence at Week I-12 [Срок оценки: At Week I-12]
DB Induction Study: Percentage of Adult Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to Week I-12]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Двойное слепое
Основная цель: Лечение