A Study to Evaluate the Efficacy and Safety of CHF10196 Tablets (Florensocatib) Compared With Placebo in Male and Female Participants 12 to 85 Years of Age With Bronchiectasis

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Bronchiectasis

In brief

This study aims to find out whether the tablet CHF10196 is safe and effective for people with non-cystic fibrosis bronchiectasis, a long-term lung disease that causes widened airways, mucus buildup, infections, and flare ups of symptoms. The main goal is to see whether CHF10196 can reduce the number of lung flareups each year compared with placebo. The study will also assess whether it can improve lung function, quality of life, and overall safety. The study has two phases. In the first phase, participants receive either CHF10196 tablets or placebo without knowing which one they are taking. In the second phase, all participants receive CHF10196 so its long-term safety can be further studied. Adults aged 18 to 85 years and adolescents aged 12 to under 18 years can take part, while continuing their usual stable bronchiectasis treatment. Up to about 2.5 years of participation are planned. Around 904 participants will be enrolled, with regular clinic visits and phone check ins. In the first phase, participants take either CHF10196 or inactive tablets once daily; in the second phase, everyone takes CHF10196 once daily. Temporary treatment interruptions are allowed if needed, and participants who stop treatment early may still continue study visits, depending on the study phase.

Key facts

Study ID

NCT07577804

Run by

Chiesi Farmaceutici S.p.A.

People needed

904

Starts

2026-11-01

Expected to finish

2030-04-01

Last updated by the study team

2026-06-24

Who can join

Age: 12 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

Full record on ClinicalTrials.gov

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