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).

Condition studied

Non-cystic fibrosis bronchiectasis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT)

Endpoint detail

Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1), Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1), Change from baseline to Week 24 in pre-bronchodilator forced expiratory volume in 1 second (FEV1), Change from baseline to Week 52 in pre-bronchodilator forced expiratory volume in 1 second (FEV1), Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 24, Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 52, Responder status for being exacerbation-free over the 24-week study period, Responder status for being exacerbation-free over the 52-week study period, Annualized rate of severe pulmonary exacerbation (PEx) from baseline up to Week 24, Annualized rate of severe pulmonary exacerbation (PEx) from baseline up to Week 52, Responder status for being severe exacerbation-free over the 24-week study period, Responder status for being severe exacerbation-free over the 52-week study period, Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), adverse events (AEs) leading to permanent study treatment discontinuation throughout the study, Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) throughout the study, Plasma concentration of SAR445399 at prespecified timepoints throughout the study, Incidence of anti-drug antibodies (ADAs) against SAR445399 throughout the study