PDY19372
Research type
Research Study
Full title
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).
IRAS ID
1013009
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Research summary
What is non-cystic fibrosis bronchiectasis?
Non-cystic fibrosis bronchiectasis (NCFB) is a lung disease. The tubes that carry air to your lungs get hurt and make too much thick mucus. People with NCFB cough a lot and make thick sputum. They get lung infections that keep coming back. As time goes on, breathing becomes increasingly difficult, making everyday life more challenging for patients.What is the reason for the study? (Rationale)
Researchers want to find out how well SAR445399 works compared to placebo (dummy medicine) as a treatment for people with NCFB, as well as how safe SAR445399 is.Goals (Objectives) and measurements (Endpoints)
Goals Measurements: Main (primary): To find out the effect of SAR445399 compared to placebo (a dummy medicine) Change in the amount of mucus blockages in different parts of the lungs, measured from detailed chest scans, from when the study started until Week 24.How the study is set up (Study Design)
This study is a double-blind, placebo-controlled, 2-arm study where each person participates for up to 66 weeks, with a treatment duration of up to 52 weeks. “Double-blinded” means that neither the people taking part nor the study doctors know who is given the study medicine or the placebo. This is done to make sure that the study results are not influenced in any way.
About the study setup: The study looks at the activity and safety of SAR445399 in 2 groups of people. Approximately the same number of patients are included in both groups: participants get the SAR445399 and participants get the placebo.What medicines are being studied? (Intervention)
SAR445399 is the medicine being studied. Participants will receive either test medication SAR445399 or a placebo. The placebo looks like the medicine being tested, but it does not have any real medicine in it. That is why we call it a “dummy medicine”. The treatment is randomly chosen for each participant meaning determined by chance using a computer program.REC name
South Central - Berkshire Research Ethics Committee
REC reference
26/SC/0004
Date of REC Opinion
30 Apr 2026
REC opinion
Further Information Favourable Opinion