A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 1… (NCT07547436) | Clinical Trial Compass
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
United States70 participantsStarted 2026-06-08
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)