Actively Recruiting
Randomized, Double-blind, Placebo-controlled Phase 2a Study of SAR445399 in Adults with Non-Cystic Fibrosis Bronchiectasis
Led by Sanofi · Updated on 2026-06-03
70
Participants Needed
3
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the activity, safety, and tolerability of SAR445399 in adults aged 18 to 80 years with non-cystic fibrosis bronchiectasis (NCFB). This randomized, double-blind, placebo-controlled Phase 2a study aims to measure how SAR445399 reduces mucus plug score compared with a placebo over 24 weeks of treatment. The study focuses on adults with clinical and radiologic evidence of NCFB and a history of pulmonary exacerbations requiring antibiotic treatment. Participants will be randomly assigned to receive either SAR445399 or a placebo, both given as injections. The treatment period lasts 24 weeks, during which the primary outcome is the change in mucus plug score measured by chest high-resolution computerized tomography (HRCT). Secondary outcomes include lung function changes measured by forced expiratory volume in 1 second (FEV1), rates of pulmonary exacerbations, safety events, and drug concentration and antibody levels, with monitoring continuing up to 66 weeks. During the study, participants will undergo chest HRCT scans, lung function tests, and assessments for exacerbations and adverse events. Researchers will monitor blood samples for drug levels and immune responses. Follow-up visits will continue through Week 66 to assess long-term safety and treatment effects. Overall, participant involvement includes clinical evaluations, imaging studies, laboratory tests, and careful safety monitoring throughout the trial period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 to 80 years old at consent
- Clinical history consistent with non-cystic fibrosis bronchiectasis such as chronic productive cough or recurrent respiratory infections
- Documented at least 2 pulmonary exacerbations requiring antibiotics for 5 or more days within the past 12 months
- Radiologic confirmation of bronchiectasis by chest high-resolution CT
- Minimum mucus plug score of 4 on chest HRCT before baseline
- Current sputum production with chronic expectoration lasting 3 or more months within the previous year
- Post-bronchodilator FEV1 of at least 30% of predicted normal value
You will not qualify if you...
- Primary diagnosis of smoking-related COPD or asthma
- Diagnosis of allergic bronchopulmonary aspergillosis or other allergic bronchopulmonary mycoses
- Active nontuberculous mycobacterial lung infection or incomplete treatment
- Bronchiectasis caused by cystic fibrosis, common variable immunodeficiency, alpha-1 antitrypsin deficiency, or primary ciliary dyskinesia
- History of significant hemoptysis requiring medical intervention or blood transfusion
- Current tobacco smokers
- Known or suspected immunosuppression, including history of invasive opportunistic infections
- Active autoimmune disease or use of immunosuppressive therapy for autoimmune conditions such as lupus, rheumatoid arthritis, or multiple sclerosis
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either SAR445399 or placebo to assess the activity and safety of the study drug.
Regular visits for study drug administration and assessments
Duration - Up to 42 weeks after treatment
Participants are monitored for safety and long-term outcomes after treatment ends.
Visits up to Week 66 for safety and outcome assessments
Trial Site Locations
Total: 3 locations
1
Advanced Pulmonary Research Institute- Site Number : 8400001
Loxahatchee Groves, Florida, United States, 33470
Actively Recruiting
2
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation, Florida, United States, 33324
Actively Recruiting
3
Clinical Research Associates of Central Pennsylvania- Site Number : 8400006
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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