中等度から重度の活動性クローン病患者におけるデュ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

NCT07184931

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, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week 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). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)