H1抗ヒスタミン薬で十分な効果が得られない青年および成人の慢性蕁麻疹に対するリゲリズマブの第III相試験および有効性。

基本情報

NCT ID

NCT03580356

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

1,078

治験依頼者名

Novartis

概要

The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

対象疾患

介入

依頼者（Sponsor）