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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).

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523403-29-00
Enrollment
25
Registered
2026-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cystic fibrosis bronchiectasis

Brief summary

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

Detailed description

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

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 25, 2026