中等度から重度の活動性潰瘍性大腸炎患者におけるドゥバキトゥグの有効性と安全性を調査するための導入試験
基本情報
- NCT ID
- NCT07184996
- ステータス
- 募集中
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 980
- 治験依頼者名
- Sanofi
概要
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction 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 35 weeks with: * Screening period * 12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction) * 12-week Sub-Study 3 (Extended Induction for non-responders) * 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359) The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.