A Study to Evaluate the Efficacy and Safety of CHF10196 Tablets (Florensocatib) Compared With Pla… (NCT07577804) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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
904 participantsStarted 2026-11
Plain-language summary
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.
Who can participate
Age range
12 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated informed consent obtained prior to any study-related procedure; Adolescents: Written informed consent obtained from the parent(s)/legally authorised representative(s) (according to the local regulation) and written or verbal assent by the participant (when appropriate), obtained prior to any study-related procedures;
. Adults: Male or female participant ≥18 and ≤85 years of age; Adolescents: Male or female participant ≥12 and \<18 years of age;
. Adults: BMI (body mass index) \>18.5 kg/m² at screening; Adolescents: Body weight \>30 kg at screening;
. Clinical history consistent with bronchiectasis (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by centralised reading of a chest CT, not more than 5 years old demonstrating bronchiectasis affecting 1 or more lobes; Note: If no recent chest CT is available, or if the records/report is not available, a new CT chest will be performed during the screening period;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The annualised rate of adjudicated pulmonary exacerbations
. A history of at least 2 pulmonary exacerbations treated with antibiotics, or 1 pulmonary exacerbation treated with antibiotics with additional risk factors (SGRQ Symptoms score at screening \>40) in the past 12 months prior to screening; Adolescents: A history of at least 1 pulmonary exacerbation in the 12 months prior to screening;
. Post-bronchodilator FEV1 ≥30% of the predicted value, calculated using the Global Lung Function Initiative 2012 reference equations; Note: in case post-bronchodilator spirometry quality is not judged satisfactory as per ATS/ERS acceptability and usability criteria\*, it may be re-checked on the same day (after a sufficient period of rest) or once before randomisation if it cannot be performed on the same day;
. Participants may either be:
. Able to provide sputum at screening (adults only);
Exclusion criteria
. Participants who have experienced any degree of pulmonary exacerbation or are experiencing a pulmonary exacerbation within 4 weeks prior to screening or during the screening period; Note: Participants can be rescreened only after recovery and 4 weeks after the last dose of antibiotic treatment;
. Current diagnosis of CF (cystic fibrosis) as determined by Investigator;
. Known history of invasive opportunistic infections (such as but not limited to histoplasmosis, pneumocystosis, or aspergillosis) and/or abnormally frequent or prolonged infections suggesting an immunocompromised status judged incompatible with the introduction of a DPP1 inhibitor by the Investigator;
. Diagnosis of A1ATD -Alpha-1-antitrypsin deficiency- (defined as A1AT serum level \<110 mg/dL) currently being treated with augmentation therapy; Note: A prior test result of A1AT serum level to confirm the diagnosis will be acceptable;
. Participants with a diagnosis of non-tuberculosis mycobacteria, pulmonary infection or TB (tuberculosis), or allergic bronchopulmonary aspergillosis currently being treated or requiring treatment as determined by the Investigator;
. Participants receiving a systemic immunosuppressive therapy for the treatment of an autoimmune disease;
. History of malignancy in the past 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ and papillary thyroid carcinoma) or treatment of malignancy in the past 5 years;
. Have significant haemoptysis (≥300 mL or requiring blood transfusion) within 4 weeks prior to screening or during the screening period;