Non-cystic Fibrosis BronchiectasisPhase 2NCT07547436
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 study testing SAR445399 in people with Non-cystic Fibrosis Bronchiectasis, run by Sanofi at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- SAR445399
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Jun 2026to 11 May 2029
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Research Associates of Central Pennsylvania- Site Number : 8400006
DuBois, Pennsylvania, 15801
Advanced Pulmonary Research Institute- Site Number : 8400001
Loxahatchee Groves, Florida, 33470
Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400008
Phoenix, Arizona, 85006
Hull and Hull Medical Specialists- Site Number : 8400002
Plantation, Florida, 33324
About this study
Official title: 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 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
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- SAR445399, Placebo
- Keywords
- Non-Cystic Fibrosis Bronchiectasis, NCFB, Bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR445399Biological
Pharmaceutical form:
solution for injection
Route of administration:
injection
PlaceboBiological
Pharmaceutical form:
solution for injection
Route of administration:
injection
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will receive SAR445399 Receives: Biological: SAR445399 |
| Arm B | Placebo comparator | Participants will receive placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline up to Week 24
Secondary outcomes (16)
Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1)
Post-bronchodilator forced expiratory volume in 1 second
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from baseline up to Week 66
Plasma concentration of SAR445399 at prespecified timepoints throughout the study
Measured: from baseline up to Week 66
Incidence of anti-drug antibodies (ADAs) against SAR445399 throughout the study
Measured: from baseline up to Week 66
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start8 Jun 2026
- Primary completion29 Oct 2027 (estimated)
- Study completion11 May 2029 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547436
- Sponsor's protocol ID
- PDY19372
- Other IDs
- 2025-523403-29, U1111-1322-6304, 2025
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07547436
- Acronym / sponsor ID
- PDY19372
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Keywords
- Non-Cystic Fibrosis Bronchiectasis, NCFB, Bronchiectasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 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.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 11 May 2029 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: SAR445399Participants will receive SAR445399 |
| Arm B | Placebo comparator | Biological: PlaceboParticipants will receive placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR445399Pharmaceutical form: solution for injection Route of administration: injection | Biological | Arm A |
| PlaceboPharmaceutical form: solution for injection Route of administration: injection | Biological | Arm B |
Primary outcome
Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT)
Time frame: from baseline up to Week 24
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
16 secondary outcomes
Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1)
Time frame: from baseline up to Week 24
Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1)
Time frame: from baseline up to Week 52
Change from baseline to Week 24 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Time frame: from baseline up to Week 24
Change from baseline to Week 52 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Time frame: from baseline up to Week 52
Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 24
Time frame: from baseline up to Week 24
Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 52
Time frame: from baseline up to Week 52
Responder status for being exacerbation-free over the 24-week study period
Time frame: from baseline up to Week 24
Responder status for being exacerbation-free over the 52-week study period
Time frame: from baseline up to Week 52
Annualized rate of severe pulmonary exacerbation (PEx) from baseline up to Week 24
Time frame: from baseline up to Week 24
Annualized rate of severe pulmonary exacerbation (PEx) from baseline up to Week 52
Time frame: from baseline up to Week 52
Responder status for being severe exacerbation-free over the 24-week study period
Time frame: from baseline up to Week 24
Responder status for being severe exacerbation-free over the 52-week study period
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- pdy19372 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR445399 in people with Non-cystic Fibrosis Bronchiectasis, run by Sanofi at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT) (time frame: from baseline up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.