A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants With Non-Cystic Fibrosis Bronchiectasis (NCFB)
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).
• 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