Health TrialsbyHealthPanel

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

ConditionNon-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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SAR445399

    Biological/Vaccine

    Pharmaceutical form: solution for injection Route of administration: injection

  • Placebo

    Biological/Vaccine

    Pharmaceutical form: solution for injection Route of administration: injection

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Mucus plug score is determined by counting the number of bronchopulmonary segments that contain at least one mucus plug, defined as a complete occlusion of the airway The total MPS ranges from 0 to 18 with higher scores indicating worse outcome

Time frame
from baseline up to Week 24

Secondary outcomes

1

Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

Post-bronchodilator forced expiratory volume in 1 second

Time frame
from baseline up to Week 24
2

Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

Post-bronchodilator forced expiratory volume in 1 second

Time frame
from baseline up to Week 52
3

Change from baseline to Week 24 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

Pre-bronchodilator forced expiratory volume in 1 second

Time frame
from baseline up to Week 24
4

Change from baseline to Week 52 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

Pre-bronchodilator forced expiratory volume in 1 second

Time frame
from baseline up to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
Apply now