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

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)

• ClinicalTrials.gov (NIH, США)

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