H1-抗ヒスタミン薬でコントロール不十分な日本人CSU患者を対象としたリゲリズマブの安全性および有効性試験

基本情報

NCT ID

NCT03907878

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

66

治験依頼者名

Novartis

概要

The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses. The study population consisted of 66 male and female subjects aged ≥ 18 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-AH. This was a Phase III multi-center, open-label, single arm study. There was a screening period of up to 28 days, a 52 week treatment period, and a 12 week post-treatment follow-up period.

対象疾患

介入

依頼者（Sponsor）