中等度から重度のアトピー性皮膚炎の成人患者を対象に、皮下投与のルンセキミグ（SAR443765）とプラセボを比較した有効性と安全性を検討する試験
基本情報
- NCT ID
- NCT06790121
- ステータス
- 実施中（募集終了）
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 150
- 治験依頼者名
- Sanofi
概要
This is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD). This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD who have a documented history, within 6 months prior to baseline, of an inadequate response to topical treatments or for whom topical therapies are not advised. The study consists of 6 arms: 3 parallel dosing regimens and matching placebo arms. Additionally, participants have the option of engaging in a dense pharmacokinetic/pharmodynamic (PK/PD) sampling subgroup. The study duration will be up to approximately 36 weeks, including up to 4 weeks of screening, 24 weeks of treatment period and an 8-week safety follow-up period.