A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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 Ulcerative Colitis

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). 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 Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 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

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by modified Mayo Score (mMS). [Срок оценки: Week 40]

Вторичные конечные точки (12)

• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic improvement. [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving histologic endoscopic mucosal improvement. [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with corticosteroid-free clinical remission. [Срок оценки: Week 40]
• Proportion of participants with no bowel urgency. [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Change from Baseline in PROMIS-Fatigue Short Form 7a T-score. [Срок оценки: Baseline, Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with endoscopic remission. [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission by mMS, in the subset of participants who achieved clinical remission by mMs at the end of induction period (maintenance of clinical remission). [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with no abdominal pain by Numerical Rating Scale (NRS). [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Incidence of UC-related hospitalizations. [Срок оценки: Week 0 through Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission. [Срок оценки: Week 40]
• Pivotal Maintenance Sub-Study Cohort 1: Proportion of participants achieving clinical remission and no steroid use from the baseline to the time of endpoint analysis. [Срок оценки: 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 SUNSCAPE-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 participant'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 · 28 центров

• Del Sol Research Management, LLC - Site Number: 8400012 — Tucson
• Southern California GI & Liver Centers - Site Number: 8400062 — Coronado
• United Medical Doctors CA - Site Number: 8400044 — Murrieta
• Om Research, LLC - Victorville - Site Number: 8400022 — Victorville
• Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039 — Colorado Springs
• Royal Palm Clinical Research - Site Number: 8400065 — Fort Myers
• Clinical Research of Osceola - Site Number: 8400013 — Kissimmee
• Bioresearch Partner-Kendale Lakes - Site Number: 8400053 — Miami
• … и ещё 20 центров

Япония · 6 центров

• Tokai University Hachioji Hospital - Site Number : 3920031 — Hachiōji
• Investigational Site Number : 3920049 — Kagoshima
• Investigational Site Number : 3920030 — Kamakura
• Investigational Site Number : 3920019 — Kobe
• Investigational Site Number : 3920029 — Sapporo
• Investigational Site Number : 3920009 — Tsu

Украина · 5 центров

• Investigational Site Number : 8040001 — Kyiv
• Investigational Site Number : 8040002 — Kyiv
• Investigational Site Number : 8040005 — Lviv
• Investigational Site Number : 8040006 — Uzhhorod
• Investigational Site Number : 8040008 — Vinnytsia

Канада · 2 центра

• Investigational Site Number : 1240003 — Toronto
• Charlton Digestive Disease Centre - Site Number : 1240009 — Hamilton

Сербия · 2 центра

• Investigational Site Number : 6880001 — Belgrade
• Investigational Site Number : 6880002 — Belgrade

Грузия · 1 центр

• Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC - Site Number : 2680002 — Tbilisi

Литва · 1 центр

• Investigational Site Number : 4400002 — Panevezys

Польша · 1 центр

• SONOMED - Site Number : 6160020 — Szczecin

Идентификаторы

NCT: NCT07185009 · EFC18359 · 2025-521038-27

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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