非嚢胞性線維症性気管支拡張症患者におけるイテペキマブ（抗IL-33 mAb）の有効性、安全性および忍容性を評価する概念実証研究

基本情報

NCT ID

NCT06280391

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

312

治験依頼者名

Sanofi

概要

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.

対象疾患

介入

依頼者（Sponsor）