SAR445399
BiologicalPharmaceutical form:
solution for injection
Route of administration:
injection
NCT Number: NCT07547436
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).
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400008, Phoenix, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Pharmaceutical form:
solution for injection
Route of administration:
injection
Pharmaceutical form:
solution for injection
Route of administration:
injection
Time frame: from baseline up to Week 24
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
Post-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 52
Post-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 24
Pre-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 52
Pre-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 24
Pulmonary exacerbations (PEx) were defined as a worsening of 3 or more major symptoms over a 48-hour period, including increased cough, increased sputum volume or changes in sputum consistency, increased sputum purulence, increased breathlessness, decreased exercise tolerance, fatigue and/or malaise, and hemoptysis. These symptoms had to lead to a healthcare provider's decision to prescribe systemic antibiotics
Time frame: from baseline up to Week 52
Pulmonary exacerbations (PEx) were defined as a worsening of 3 or more major symptoms over a 48-hour period, including increased cough, increased sputum volume or changes in sputum consistency, increased sputum purulence, increased breathlessness, decreased exercise tolerance, fatigue and/or malaise, and hemoptysis. These symptoms had to lead to a healthcare provider's decision to prescribe systemic antibiotics
Time frame: from baseline up to Week 24
Proportion of patients without a pulmonary exacerbation (PEx) event from baseline up to Week 24
Time frame: from baseline up to Week 52
Proportion of patients without pulmonary exacerbation (PEx) event from baseline up to Week 52
Time frame: from baseline up to Week 24
A pulmonary exacerbation is classified as severe when it necessitates either:Intravenous antibacterial treatment, and/or hospital admission
Time frame: from baseline up to Week 52
A pulmonary exacerbation is classified as severe when it necessitates either:Intravenous antibacterial treatment, and/or hospital admission
Time frame: from baseline up to Week 24
Proportion of patients without a severe pulmonary exacerbation (PEx) event from baseline up to Week 24
Time frame: from baseline up to Week 52
Proportion of patients without a severe pulmonary exacerbation (PEx) event from baseline up to Week 52
Time frame: from baseline up to Week 66
Incidence of participants with TEAEs, including AESIs, and SAEs
Time frame: from baseline up to Week 66
Time frame: from baseline up to Week 66
Time frame: from baseline up to Week 66
Contact information is provided by the study sponsor or research team.
Sanofi
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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