BENITIONSClinical Trial Intelligence

A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)

第2相 完了 NCT05865886

対象疾患Cystic Fibrosis, Bronchiectasis
第2相
スポンサーBoehringer Ingelheim
ステータス完了
参加者数22 名
介入(薬剤)BI 1291583, Placebo to BI 1291583
開始日2024年4月5日
完了日2024年10月7日
結果公開日2025年11月18日

概要

This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.

Occurrence of Any Treatment Emergent Adverse Events

From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks. · Percentage of participants

Placebo85.7 Percentage of participants
BI 1291583 5 mg93.3 Percentage of participants

BENITIONS で見る ClinicalTrials.gov の原文を見る

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