Идёт набор NCT06588855

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Фаза III С лечением Moderately to Severely Active Ulcerative Colitis

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: Afimkibart, Placebo.
Кому может быть актуально: Состояния в реестре: Moderately to Severely Active Ulcerative Colitis. Базовые параметры: 16 лет — 80 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, Австрия, Бельгия +25
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 III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

Обзор

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Вмешательства

Препарат Afimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Препарат Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Первичные конечные точки

Percentage of Participants with Clinical Remission [Срок оценки: At Week 12]

Вторичные конечные точки (12)

Change in Partial Modified Mayo Score (pmMS) [Срок оценки: From baseline to Week 2]
Percentage of Participants with Endoscopic Improvement [Срок оценки: At Week 12]
Percentage of Participants with Endoscopic Remission [Срок оценки: At Week 12]
Percentage of Participants with Clinical Response [Срок оценки: At Week 12]
Percentage of Participants with Histologic Improvement [Срок оценки: At Week 12]
Percentage of Participants with Histologic Remission [Срок оценки: At Week 12]
Participants with Histologic-Endoscopic Mucosal Improvement [Срок оценки: At Week 12]
Percentage of Participants with Histologic-Endoscopic Remission [Срок оценки: At Week 12]
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants [Срок оценки: At Week 12]
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants [Срок оценки: At Week 12]
Change in Bowel Urgency [Срок оценки: Baseline through Week 12]
Change in Abdominal Pain [Срок оценки: Baseline through Week 12]

Критерии участия

Критерии включения

Confirmed diagnosis of UC
Moderately to severely active UC assessed by mMS
Bodyweight >= 40 kilogram (kg)
Up to date with colorectal cancer (CRC) screening performed according to local standards
Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Критерии исключения

Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
Presence of an ostomy or ileoanal pouch
Current diagnosis or suspicion of primary sclerosing cholangitis
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

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