アレルギー性気管支肺アスペルギルス症(ABPA)患者におけるデュピルマブ治療の検討(LIBERTY ABPA AIRED)
基本情報
- NCT ID
- NCT04442269
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 62
- 治験依頼者名
- Regeneron Pharmaceuticals
概要
The primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA). The secondary objectives of the study are: * To evaluate the effects of dupilumab on exacerbations in participants with ABPA * To evaluate the effects of dupilumab on ABPA-related exacerbations * To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent care visits in participants with ABPA * To evaluate the effects of dupilumab on asthma control in participants with ABPA * To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in participants with ABPA * To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and Aspergillus-specific IgE concentrations * To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels * To evaluate safety and tolerability of dupilumab in participants with ABPA * To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with ABPA
対象疾患
介入
実施施設 (7)
Regeneron Study Site
Yanagawa, Japan
東海大学医学部付属病院
Kanagawa, Japan
藤田医科大学ばんたね病院
Nagoya, Japan
Regeneron Study Site
Sakai, Japan
Regeneron Study Site
Naka-gun, Japan
横浜市立みなと赤十字病院
Yokohama, Japan
Regeneron Study Site
Fukuyama, Japan