SuspendedNCT07547436Updated Jul 29, 2026

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

A Phase 2 interventional study of SAR445399 and Placebo in Non-cystic Fibrosis Bronchiectasis, sponsored by Sanofi. Suspended at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Why this study was suspended

The pause is for strategic business reasons to facilitate internal portfolio review. The pause is not due to any concerns with patient safety, with program benefit/risk, or with trial integrity.

Phase: Phase 2
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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).

Conditions studied

Non-cystic Fibrosis Bronchiectasis

Browse trials for

Bronchiectasis 369

Keywords

Non-Cystic Fibrosis Bronchiectasis
NCFB
Bronchiectasis

In context

Bronchiectasis

369 studies on the registry are indexed under Bronchiectasis; 105 are open to participants now.

This study's planned enrollment of 70 is above the median of 60 across 233 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 70 participants (estimated)

Study arms

Experimental
Arm A
Participants will receive SAR445399
Biological: SAR445399
Placebo comparator
Arm B
Participants will receive placebo
Biological: Placebo

Interventions

BiologicalSAR445399
Pharmaceutical form: solution for injection Route of administration: injection
BiologicalPlacebo
Pharmaceutical form: solution for injection Route of administration: injection

What researchers measure

Primary outcomes

Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT)
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

Secondary outcomes

Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1)
Post-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 24
Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1)
Post-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 52
Change from baseline to Week 24 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Pre-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 24
Change from baseline to Week 52 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Pre-bronchodilator forced expiratory volume in 1 second
Time frame: from baseline up to Week 52
Annualized rate of pulmonary exacerbation (PEx) 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 24
Annualized rate of pulmonary exacerbation (PEx) 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 52
Responder status for being exacerbation-free over the 24-week study period
Proportion of patients without a pulmonary exacerbation (PEx) event from baseline up to Week 24
Time frame: from baseline up to Week 24
Responder status for being exacerbation-free over the 52-week study period
Proportion of patients without pulmonary exacerbation (PEx) event from baseline up to Week 52
Time frame: from baseline up to Week 52
Annualized rate of severe pulmonary exacerbation (PEx) 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 24
Annualized rate of severe pulmonary exacerbation (PEx) 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 52
Responder status for being severe exacerbation-free over the 24-week study period
Proportion of patients without a severe pulmonary exacerbation (PEx) event from baseline up to Week 24
Time frame: from baseline up to Week 24
Responder status for being severe exacerbation-free over the 52-week study period
Proportion of patients without a severe pulmonary exacerbation (PEx) event from baseline up to Week 52
Time frame: from baseline up to Week 52
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), adverse events (AEs) leading to permanent study treatment discontinuation throughout the study
Incidence of participants with TEAEs, including AESIs, and SAEs
Time frame: from baseline up to Week 66
Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) throughout the study
Time frame: from baseline up to Week 66
Plasma concentration of SAR445399 at prespecified timepoints throughout the study
Time frame: from baseline up to Week 66
Incidence of anti-drug antibodies (ADAs) against SAR445399 throughout the study
Time frame: from baseline up to Week 66

Study locations

4 sites

Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400008
Phoenix, Arizona 85006, United States
Advanced Pulmonary Research Institute- Site Number : 8400001
Loxahatchee Groves, Florida 33470, United States
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation, Florida 33324, United States
Clinical Research Associates of Central Pennsylvania- Site Number : 8400006
DuBois, Pennsylvania 15801, United States

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07547436
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Apr 23, 2026
Start date: Jun 8, 2026
Primary completion: Oct 29, 2027 (estimated)
Completion: May 11, 2029 (estimated)
Last update: Jul 29, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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