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NCT Number: NCT07547436

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400008, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR445399

Biological

Pharmaceutical form:

solution for injection

Route of administration:

injection

Placebo

Biological

Pharmaceutical form:

solution for injection

Route of administration:

injection

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

    Time frame: from baseline up to Week 24

    Post-bronchodilator forced expiratory volume in 1 second

  2. Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

    Time frame: from baseline up to Week 52

    Post-bronchodilator forced expiratory volume in 1 second

  3. Change from baseline to Week 24 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

    Time frame: from baseline up to Week 24

    Pre-bronchodilator forced expiratory volume in 1 second

  4. Change from baseline to Week 52 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

    Time frame: from baseline up to Week 52

    Pre-bronchodilator forced expiratory volume in 1 second

  5. Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 24

    Time frame: 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

  6. Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 52

    Time frame: 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

  7. Responder status for being exacerbation-free over the 24-week study period

    Time frame: from baseline up to Week 24

    Proportion of patients without a pulmonary exacerbation (PEx) event from baseline up to Week 24

  8. Responder status for being exacerbation-free over the 52-week study period

    Time frame: from baseline up to Week 52

    Proportion of patients without pulmonary exacerbation (PEx) event from baseline up to Week 52

  9. Annualized rate of severe pulmonary exacerbation (PEx) from baseline up to Week 24

    Time frame: from baseline up to Week 24

    A pulmonary exacerbation is classified as severe when it necessitates either:Intravenous antibacterial treatment, and/or hospital admission

  10. Annualized rate of severe pulmonary exacerbation (PEx) from baseline up to Week 52

    Time frame: from baseline up to Week 52

    A pulmonary exacerbation is classified as severe when it necessitates either:Intravenous antibacterial treatment, and/or hospital admission

  11. Responder status for being severe exacerbation-free over the 24-week study period

    Time frame: from baseline up to Week 24

    Proportion of patients without a severe pulmonary exacerbation (PEx) event from baseline up to Week 24

  12. Responder status for being severe exacerbation-free over the 52-week study period

    Time frame: from baseline up to Week 52

    Proportion of patients without a severe pulmonary exacerbation (PEx) event from baseline up to Week 52

  13. 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 participants with TEAEs, including AESIs, and SAEs

  14. 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

  15. Plasma concentration of SAR445399 at prespecified timepoints throughout the study

    Time frame: from baseline up to Week 66

  16. Incidence of anti-drug antibodies (ADAs) against SAR445399 throughout the study

    Time frame: from baseline up to Week 66

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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