SAR445399 versus placebo for adults 18–80 with non-cystic fibrosis bronchiectasis
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)
This Phase 2 trial will test whether SAR445399 reduces mucus plugs over 24 weeks in adults (18–80) with non-cystic fibrosis bronchiectasis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 1 site (Loxahatchee Groves, Florida) |
| Trial ID | NCT07547436 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 2 trial comparing SAR445399 to placebo over 24 weeks to measure change in mucus plug score on chest HRCT. Eligible adults must have HRCT-confirmed bronchiectasis with a minimum mucus plug score (MPS) of 4, chronic sputum production, and at least two antibiotic-treated pulmonary exacerbations in the prior year. Participants receive either SAR445399 or placebo and are monitored for changes in MPS, lung function, exacerbations, and safety outcomes. The protocol requires a post-bronchodilator FEV1 ≥30% and includes regular clinic visits at the study site for imaging and assessments.
Who should consider this trial
Good fit: Adults aged 18–80 with HRCT-confirmed non-cystic fibrosis bronchiectasis, an MPS ≥4, chronic sputum production, at least two physician-treated exacerbations in the prior 12 months, and post-bronchodilator FEV1 ≥30% are the ideal candidates.
Not a fit: Patients whose primary diagnosis is smoking-related COPD or asthma, those with MPS <4, without recurrent exacerbations, or with FEV1 <30% are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, SAR445399 could reduce mucus plugging, improve airway clearance, and potentially lower exacerbations and respiratory symptoms.
How similar studies have performed: Macrolide antibiotics and airway-clearance strategies have shown benefit in bronchiectasis, but novel targeted agents like SAR445399 have limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 immunosuppression, including history of invasive opportunistic infections (eg., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune-compromised status, as judged by the Investigator * Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease, including but not limited to connective tissue diseases (eg., systemic lupus erythematosus, scleroderma, polymyositis, dermatomyositis, mixed connective tissue disease), rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Hashimoto's thyroiditis, Graves' disease, primary biliary cirrhosis, and psoriasis vulgaris The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Where this trial is running
Loxahatchee Groves, Florida
- Advanced Pulmonary Research Institute- Site Number : 8400001 — Loxahatchee Groves, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.