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A Study of SAR445399 in Adults Aged 18‑80 with Non‑cystic Fibrosis Bronchiectasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on adults with Non-cystic fibrosis bronchiectasis, a lung condition in which the airways become permanently widened and fill with thick mucus, leading to frequent infections and breathing difficulty. Participants will receive either the investigational drug SAR445399, administered as a subcutaneous injection, or a matching placebo.

The purpose of the study is to assess whether SAR445399 can lower the amount of mucus plugs in the lungs and improve overall lung health compared with placebo. The main measurement is the change in mucus plug score obtained from high-resolution computerized tomography, a detailed chest scan that shows the presence of mucus blockages. Additional evaluations include changes in forced expiratory volume in 1 second, a test that measures how much air can be expelled in one second, and the frequency of pulmonary exacerbation, which refers to episodes of worsening breathing problems that may require extra treatment.

Participants will be randomly assigned to one of the two groups and will receive the assigned injection at regular clinic visits over a period of several months. Throughout the study, participants will undergo the chest scan and breathing tests at the start and at later visits, and their safety will be monitored through routine check‑ups and laboratory tests.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and assignment

    After joining the study, the participant is randomly assigned to receive either SAR445399 or a matched placebo. the assignment is double‑blinded, meaning neither the participant nor the study staff know which product is being given.

  2. Step 2

    Baseline assessments

    Before any medication is given, a series of baseline measurements are performed:

    chest high‑resolution computerized tomography (HRCT) – a detailed lung scan used to calculate the mucus plug score (MPS);

    forced expiratory volume in 1 second (FEV1) – a lung function test performed both after and before using a bronchodilator; and

    Standard laboratory tests, vital‑sign measurements, and a 12‑lead electrocardiogram (ECG) to record the participant’s health status.

  3. Step 3

    First dose administration

    The participant receives the first subcutaneous injection (injection under the skin) of the assigned product.

    The product is supplied as a powder for solution for injection; the dose listed in the protocol is 00 mg.

    The injection is prepared and administered by qualified study personnel in accordance with the study protocol.

  4. Step 4

    Regular dosing visits

    At each scheduled study visit, the participant receives another subcutaneous injection of the same product (either SAR445399 or placebo).

    The timing of these visits follows the study schedule, which continues for up to 52 weeks from the first dose.

  5. Step 5

    Interim safety and efficacy assessments

    Throughout the study, the participant undergoes periodic evaluations, including:

    Repeat HRCT scans to monitor changes in the mucus plug score;

    Repeated FEV1 measurements (both post‑ and pre‑bronchodilator) to assess lung function;

    Recording of any pulmonary exacerbations (PEx) – worsening of breathing symptoms;

    Monitoring for any adverse events (AEs), including serious events, events leading to discontinuation, and events of special interest;

    Laboratory tests, vital‑sign checks, and ECGs to detect any safety concerns.

  6. Step 6

    Week 24 assessment

    At week 24, a comprehensive set of evaluations is performed:

    HRCT to determine the change in mucus plug score from baseline;

    FEV1 measurements to evaluate lung function changes;

    Calculation of the annualized rate of pulmonary exacerbations and severe exacerbations up to week 24;

    Assessment of whether the participant remained free of exacerbations during the 24‑week period;

    Collection of blood samples to measure the plasma concentration of SAR445399 and to test for anti‑drug antibodies.

  7. Step 7

    Week 52 final assessment

    At week 52, the final study visit includes:

    Repeat HRCT and FEV1 testing to evaluate long‑term changes;

    Calculation of pulmonary exacerbation rates and severe exacerbation rates from baseline to week 52;

    Determination of exacerbation‑free status for the entire 52‑week period;

    Final safety review, including all adverse events, laboratory abnormalities, and ECG findings;

    Final blood sampling for drug concentration and anti‑drug antibody analysis.

  8. Step 8

    Study completion

    After the week 52 visit, the participant’s involvement in the trial ends.

    All study data are recorded, and the participant may be offered standard follow‑up care as determined by the treating physician.

Who can join the trial?

7 criteria

  • Be between 18 and 80 years old when you sign the consent form.
  • Have a medical history that fits non‑cystic fibrosis bronchiectasis, such as a long‑lasting cough that brings up mucus (chronic productive cough) or repeated lung infections (recurrent respiratory infections).
  • Show documented proof of at least two pulmonary exacerbations (PEx) in the past year. A PEx is a worsening of lung symptoms that required a doctor‑prescribed antibiotic (by mouth or IV) for five days or more.
  • Have a chest scan called a high‑resolution CT (HRCT) that clearly shows bronchiectasis.
  • Score at least 4 out of 18 on the mucus plug score (MPS) from the HRCT taken before the baseline visit. The MPS measures how much mucus is blocking the airways.
  • Currently produce sputum (mucus you cough up) and have a recorded history of coughing up mucus for at least three months within the last year.
  • After using a medication that opens the airways (bronchodilator), your lung function test called FEV1 must be at least 30 % of the predicted normal value. FEV1 measures the amount of air you can forcefully exhale in one second.

Who cannot join the trial?

8 criteria

  • Having a main diagnosis of smoking‑related COPD (chronic lung disease caused by smoking) or asthma (a condition that makes breathing difficult), unless bronchiectasis is clearly the main problem causing symptoms.
  • Being diagnosed with ABPA (an allergic reaction in the lungs to a fungus) or any other allergic lung infection caused by fungi.
  • Having an active lung infection with NTM (a type of bacteria called nontuberculous mycobacteria) that needs treatment now, or a past NTM infection that was not fully treated; also excluded if NTM is found during screening with symptoms or X‑ray findings that would require treatment.
  • Having bronchiectasis that is caused by any of the following conditions: CF (cystic fibrosis), CVID (a disorder that weakens the immune system), AAT deficiency (a lack of a protein that protects the lungs), or PCD (a genetic problem that affects tiny hair‑like structures in the airways).
  • Having a history of serious hemoptysis (coughing up a large amount of blood that needed medical help or a blood transfusion).
  • Being a current tobacco smoker.
  • Having known or suspected immunosuppression (a weakened immune system), which includes a past history of serious infections caused by unusual germs (called opportunistic infections, such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, or aspergillosis), frequent infections, or infections that last a long time and suggest the immune system is not working well.
  • Having an active autoimmune disease (a condition where the body attacks itself) or using medicines that suppress the immune system to treat such diseases; examples include lupus, scleroderma, polymyositis, dermatomyositis, mixed connective tissue disease, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, thyroid diseases (Hashimoto’s or Graves’), primary biliary cirrhosis, and psoriasis.
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Investigated drugs

SAR445399 is an investigational medication being tested in this study. It is given as a subcutaneous injection, meaning it is injected under the skin. The drug comes as a powder that is mixed with a liquid to create a solution for the injection. In the trial, participants receive this medication to see if it can help reduce the amount of mucus plugging in the airways of adults with non‑cystic fibrosis bronchiectasis, which may improve breathing and overall lung health.

What is already known about the treatment

SAR445399 - It is supplied as a powder that is mixed with liquid and given by injection under the skin (subcutaneous injection). The drug is still investigational and is being studied in a Phase 2a clinical trial, so it is not yet approved for routine medical use. It is being tested for adults with non‑cystic fibrosis bronchiectasis, a lung disease that causes thick mucus and repeated infections. SAR445399 works by attaching to a specific protein that regulates mucus production, helping to lower mucus buildup and airway inflammation, and it is classified as an experimental biologic therapy.

Investigated diseases

Non-cystic fibrosis bronchiectasis - Non-cystic fibrosis bronchiectasis is a chronic condition in which the airways in the lungs become widened and damaged, leading to difficulty clearing mucus. The damaged airways become flabby and lose their normal shape, causing mucus to build up. Over time, the mucus can cause repeated infections and inflammation. The ongoing cycle of infection and inflammation can further enlarge the airways and increase mucus production. People with this condition may notice a persistent cough, shortness of breath, and frequent sputum production as the disease progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523403-29-00Protocol codePDY19372Estimated enrolment113 patientsSponsorSanofi-Aventis Recherche & Developpement

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