A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age With Non-Cystic Fibrosis Bronchiectasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSanofi

About this trial

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 criteria

Qualifiers

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

Disqualifiers

A primary diagnosis of smoking-related COPD or asthma as determined by the Investigator. Participants with comorbid smoking-related COPD may be included if bronchiectasis is confirmed as their primary diagnosis and is the predominant cause of their respiratory symptoms

Diagnosis of ABPA or any of the allergic bronchopulmonary mycoses

Active NTM lung infection or incomplete NTM treatment course

Bronchiectasis due to any of the following: CF, CVID, AAT or PCD

Trial design

Treatments tested in this trial

  • SAR445399
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators