A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 1… (NCT07547436) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
70 participantsStarted 2026-04-13
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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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 performed before Baseline Visit
* Current sputum production with a documented history of chronic expectoration lasting ≥3 months within the previous 12 months
* Participants must have a post-bronchodilator FEV1 ≥30% of predicted normal value
Exclusion Criteria:
* 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
* History of significant hemoptysis (requiring medical intervention and/or requiring blood transfusion)
* Current tobacco smokers
* Known or suspected immunosuppressio…
What they're measuring
1
Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT)
Timeframe: from baseline up to Week 24
Trial details
NCT IDNCT07547436
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-10-29
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)