Идёт набор NCT06819878

A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

Фаза III С лечением Moderately to Severely Active Crohns Disease

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 Crohns Disease. 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 +33
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, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease

Обзор

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Вмешательства

Препарат Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Препарат Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Первичные конечные точки

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [Срок оценки: At Week 52]
Percentage of Participants with Endoscopic Response [Срок оценки: At Week 52]

Вторичные конечные точки (12)

Percentage of Participants with Clinical Remission [Срок оценки: At Week 12]
Percentage of Participants with Endoscopic Response [Срок оценки: At Week 12]
Percentage of Participants with Symptomatic Remission [Срок оценки: At Week 12]
Percentage of Participants with Endoscopic Remission [Срок оценки: At Week 12]
Percentage of Participants with Ulcer-free Endoscopy [Срок оценки: At Week 12]
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF) [Срок оценки: Baseline through Week 12]
Average of Daily Abdominal Pain Scores in the Past Week (APS) [Срок оценки: Baseline through Week 12]
Percentage of Participants with Endoscopic Remission [Срок оценки: At Week 52]
Percentage of Participants with Symptomatic Remission [Срок оценки: At Week 52]
Percentage of Participants with Corticosteroid-free Clinical Remission [Срок оценки: At Week 52]
Maintenance of Clinical Remission [Срок оценки: At Weeks 12 and 52]
Maintenance of Endoscopic Response [Срок оценки: At Weeks 12 and 52]

Критерии участия

Критерии включения

Confirmed diagnosis of CD
Moderately to severely active CD
Bodyweight >= 40 kilogram (kg)
Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Критерии исключения

Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
Diagnosis of short gut or short bowel syndrome
Presence of an ileostomy, colostomy or ileoanal pouch
Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
Presence of abdominal or perianal abscess
Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
Current diagnosis or suspicion of primary sclerosing cholangitis
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
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