SAR445399 compared with placebo in adults with non-cystic fibrosis bronchiectasis

Who can take part

• 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
• A minimum MPS of 4 (out of maximum 18) on chest HRCT performed before Baseline Visit
• Current sputum production with a documented history of chronic expectoration lasting ≥3 months within the previous 12 months
• Participants must have a post-bronchodilator FEV1 ≥30% of predicted normal value

Who cannot take part

• Diagnosis of ABPA or any of the allergic bronchopulmonary mycoses
• Active NTM lung infection or incomplete NTM treatment course
• History of significant hemoptysis (requiring medical intervention and/or requiring blood transfusion)
• Known or suspected immunosuppression, including history of invasive opportunistic infections (eg., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune-compromised status, as judged by the Investigator
• Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease, including but not limited to connective tissue diseases (eg., systemic lupus erythematosus, scleroderma, polymyositis, dermatomyositis, mixed connective tissue disease), rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Hashimoto's thyroiditis, Graves' disease, primary biliary cirrhosis, and psoriasis vulgaris; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
• 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
• Bronchiectasis due to any of the following: CF, CVID, AAT or PCD
• Current tobacco smokers