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)
Sanofi
Summary
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 p…
Interventions
- BiologicalSAR445399
Pharmaceutical form: solution for injection Route of administration: injection
- BiologicalPlacebo
Pharmaceutical form: solution for injection Route of administration: injection
Locations (3)
- Advanced Pulmonary Research Institute- Site Number : 8400001Loxahatchee Groves, Florida
- Hull and Hull Medical Specialists- Site Number : 8400002Plantation, Florida
- Clinical Research Associates of Central Pennsylvania- Site Number : 8400006DuBois, Pennsylvania