2歳以上12歳未満のコントロール不良慢性特発性蕁麻疹（CSU）患者を対象としたデュピルマブの薬物動態および安全性を調査する試験（LIBERTY-CSU CUPIDKids）

基本情報

NCT ID

NCT05526521

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

15

治験依頼者名

Sanofi

概要

This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.

対象疾患

介入

依頼者（Sponsor）