Идёт набор NCT07196722

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Фаза II / Фаза III С лечением Crohn 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: Icotrokinra, Placebo.
Кому может быть актуально: Состояния в реестре: Crohn Disease. Базовые параметры: от 18 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 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Обзор

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Вмешательства

Препарат Icotrokinra
Icotrokinra will be administered orally, daily.
Препарат Placebo
Matching placebo will be administered orally, daily.

Первичные конечные точки

Induction Study 1: Number of Participants with Clinical Response at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint) [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint) [Срок оценки: At Week 12]
Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint) [Срок оценки: At Week 40]
Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint) [Срок оценки: At Week 40]

Вторичные конечные точки (12)

Induction Study 1: Number of Participants with Clinical Remission at Week 12 [Срок оценки: At Week 12]
Induction Study 1: Number of Participants with Endoscopic Response at Week 12 [Срок оценки: At Week 12]
Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)]
Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Clinical Response at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Clinical Response at Week 4 [Срок оценки: At Week 4]
Induction Study 2: Number of Participants with Endoscopic Remission at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Deep Remission at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Fatigue Response at Week 12 [Срок оценки: At Week 12]
Induction Study 2: Number of Participants with Clinical Remission at Week 4 [Срок оценки: At Week 4]

Критерии участия

Критерии включения

Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but <=450 and either mean daily SF count >=4, or mean daily AP score >=2
Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >= 6 for participants with colonic or ileocolonic disease, and SES-CD >= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-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 naïve to advanced therapies (advanced drug therapy \[ADT\]-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 CD- (ADT-inadequate responder \[IR\]) as defined in the protocol

Критерии исключения

Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
Presence of a stoma or ostomy
Participants with presence of active fistulas may be included if there is no surgery needed
Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

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