中等度から重度のアトピー性皮膚炎患者（12歳以上）を対象とした皮下投与アムリテリマブの安全性と有効性を評価するオープンラベル長期試験

基本情報

NCT ID

NCT05769777

ステータス

募集中

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

901

治験依頼者名

Sanofi

概要

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

対象疾患

介入

依頼者（Sponsor）