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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

Allergic Bronchopulmonary Aspergillosis

介入

dupilumab(DRUG)
Placebo(DRUG)

依頼者(Sponsor)

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