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Compares treatment options for Non-cystic Fibrosis Bronchiectasis
Official 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
ClinicalTrials.gov ID: NCT07547436
What this study is testing
What is SAR445399?
SAR445399 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for non-cystic fibrosis bronchiectasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- A primary diagnosis of smoking-related COPD or asthma as determined by the Investigator. Participants with comorbid smoking-related COPD may be...
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Loxahatchee Groves, Florida, United States
- Plantation, Florida, United States
- DuBois, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Loxahatchee Groves, Florida, United States; Plantation, Florida, United States; DuBois, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.