Меню
Идёт набор NCT07184944

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Фаза III С лечением Crohn's 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: Duvakitug, Placebo.
Кому может быть актуально
Состояния в реестре: Crohn's 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, Канада, Грузия, Япония, Moldova +2
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

Вмешательства

  • Препарат Duvakitug
    Pharmaceutical form:Injection solution-Route of administration:SC injection
  • Препарат Placebo
    Pharmaceutical form:Injection solution-Route of administration:SC injection

Первичные конечные точки

  • Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40 [Срок оценки: Week 40]
  • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40 [Срок оценки: Week 40]
  • Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40 [Срок оценки: Week 40]
Вторичные конечные точки (12)
  • Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical response Week 40 [Срок оценки: Week 40]
  • Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving SES-CD endoscopic remission at Week 40 [Срок оценки: Week 40]
  • US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission and endoscopic remission at Week 40 [Срок оценки: Week 40]
  • EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission and endoscopic remission at Week 40 [Срок оценки: Week 40]
  • US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving PRO-2 clinical remission at Week 40 [Срок оценки: Week 40]
  • EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving CDAI clinical remission at Week 40 [Срок оценки: Week 40]
  • US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free CDAI clinical remission at Week 40 [Срок оценки: Week 40]
  • EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving corticosteroids free PRO-2 remission at Week 40 [Срок оценки: Week 40]
  • Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving ulcer-free endoscopy (in the subset of participants with ulcers at Baseline) at Week 40 [Срок оценки: Week 40]
  • US/FDA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per CDAI at Week 40 in the subset of participants with clinical remission per CDAI at Week 0 (maintenance of clinical remission per CDAI) [Срок оценки: Week 40]
  • EU/EMA Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission per PRO-2 at Week 40 in the subset of participants with clinical remission per PRO-2 at Week 0 (maintenance of clinical remission per PRO-2) [Срок оценки: Week 40]
  • Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score at Week 40 [Срок оценки: Baseline, Week 40]

Критерии участия

Критерии включения

  • Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to <18 years of age who meet the definition of Tanner stage 5 for development)
  • Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
  • OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Критерии исключения

  • Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
  • Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 22 центра
  • Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039 — Colorado Springs
  • Clinical Research of Osceola-Site Number: 8400013 — Kissimmee
  • Bioresearch Partner-Kendale Lakes-Site Number: 8400053 — Miami
  • NMC Research LLC-Site Number: 8400033 — Tampa
  • Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100 — New Albany
  • GI Alliance - Baton Rouge-Site Number: 8400129 — Baton Rouge
  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400 — Mandeville
  • Gateway Gastroenterology-Site Number: 8400097 — St Louis
  • … и ещё 14 центров
Грузия · 4 центра
  • Investigational Site Number : 2680008 — Tbilisi
  • Investigational Site Number : 2680003 — Tbilisi
  • Investigational Site Number : 2680005 — Tbilisi
  • Investigational Site Number : 2680002 — Tbilisi
Украина · 3 центра
  • Investigational Site Number : 8040005 — Lviv
  • Investigational Site Number : 8040010 — Vinnytsia
  • Investigational Site Number : 8040009 — Vinnytsia
Канада · 2 центра
  • Investigational Site Number : 1240009 — Hamilton
  • Investigational Site Number : 1240003 — Toronto
Moldova · 2 центра
  • Investigational Site Number : 4980003 — Chisinau
  • Investigational Site Number : 4980004 — Chisinau
Япония · 1 центр
  • Investigational Site Number : 3920009 — Tsu
ЮАР · 1 центр
  • Investigational Site Number : 7100001 — Kempton Park

Идентификаторы

NCT: NCT07184944 · EFC18327 · 2025-521037-86 · U1111-1314-5471

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗