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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523403-29 | Registry Identifier | CTIS | |
| U1111-1322-6304 | Registry Identifier | WHO ICTRP |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Participants will receive SAR445399 |
|
| Arm B | Placebo Comparator | Participants will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR445399 | Biological | Pharmaceutical form: solution for injection Route of administration: injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1) | Post-bronchodilator forced expiratory volume in 1 second | from baseline up to Week 24 |
| Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400008 | Recruiting | Phoenix | Arizona | 85006 | United States |
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| Label | URL |
|---|---|
| pdy19372 Plain Language Results Summary | View source |
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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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[Specify Complex Masking]
| Placebo | Biological | Pharmaceutical form: solution for injection Route of administration: injection |
|
Post-bronchodilator forced expiratory volume in 1 second |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | from baseline up to Week 66 |
| Plasma concentration of SAR445399 at prespecified timepoints throughout the study | from baseline up to Week 66 |
| Incidence of anti-drug antibodies (ADAs) against SAR445399 throughout the study | from baseline up to Week 66 |
| Advanced Pulmonary Research Institute- Site Number : 8400001 | Recruiting | Loxahatchee Groves | Florida | 33470 | United States |
| Hull and Hull Medical Specialists- Site Number : 8400002 | Recruiting | Plantation | Florida | 33324 | United States |
| Clinical Research Associates of Central Pennsylvania- Site Number : 8400006 | Recruiting | DuBois | Pennsylvania | 15801 | United States |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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