About this trial
This is a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score at 24 weeks of treatment with SAR445399 compared with placebo in adult participants aged 18 to 80 years with non-cystic fibrosis bronchiectasis (NCFB).
Eligibility criteria
Qualifiers
Participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent
Clinical history consistent with NCFB, such as chronic productive cough and/or recurrent respiratory infections
Documented evidence of at least 2 PEx defined as episodes requiring a physician-prescribed course of antibiotics (oral and/or IV) for ≥5 days for signs and symptoms of respiratory infection within the 12 months prior to the Screening Visit
Radiologic evidence of bronchiectasis, confirmed by a chest HRCT
Disqualifiers
A primary diagnosis of smoking-related COPD or asthma as determined by the Investigator. Participants with comorbid smoking-related COPD may be included if bronchiectasis is confirmed as their primary diagnosis and is the predominant cause of their respiratory symptoms
Diagnosis of ABPA or any of the allergic bronchopulmonary mycoses
Active NTM lung infection or incomplete NTM treatment course
Bronchiectasis due to any of the following: CF, CVID, AAT or PCD
Trial design
Treatments tested in this trial
- SAR445399
- Placebo