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Study on the Effects of Itepekimab for Patients 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

This clinical trial is focused on studying a lung condition called non-cystic fibrosis bronchiectasis. This condition involves damage to the airways, leading to symptoms like a persistent cough and frequent lung infections. The study will test a treatment called itepekimab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific substances in the body. Itepekimab is designed to target and block a protein called interleukin-33, which is involved in inflammation.

The purpose of the study is to evaluate how effective itepekimab is compared to a placebo in reducing lung flare-ups, known as pulmonary exacerbations, in people with non-cystic fibrosis bronchiectasis. Participants in the study will receive either itepekimab or a placebo through an injection under the skin. The study will monitor participants over a period to see how often these lung flare-ups occur and to assess the safety and tolerability of the treatment.

Throughout the study, various aspects will be observed, such as the time it takes for the first lung flare-up to occur, the number of participants who remain free from these flare-ups, and any changes in lung function. The study will also look at the quality of life related to respiratory symptoms and any side effects that may arise from the treatment. The goal is to gather information that could help improve the management of non-cystic fibrosis bronchiectasis in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the itepekimab treatment or a matched placebo. This process is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.

  2. Step 2

    Treatment administration

    The treatment involves a subcutaneous injection of itepekimab or placebo. The solution is provided in a pre-filled syringe for ease of administration.

    The frequency and dosage of the injections will be determined by the study protocol and communicated to the participant at the start of the trial.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the participant will be monitored for any changes in their condition, specifically focusing on the occurrence of pulmonary exacerbations (PEs).

    Regular assessments will be conducted to evaluate lung function, using a measure called FEV1, which stands for forced expiratory volume in one second. This will be checked at specific intervals, such as Week 8 and Week 24.

  4. Step 4

    Quality of life evaluations

    The participant's quality of life will be assessed using standardized questionnaires, such as the QOL-B Respiratory Symptoms Domain Score and the SGRQ (St. George's Respiratory Questionnaire).

    These evaluations will help determine any changes in symptoms and overall well-being at different points during the study, particularly at Week 24.

  5. Step 5

    Safety monitoring

    Safety is a priority, and the participant will be monitored for any adverse effects, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

    Blood samples may be taken to measure serum concentrations of itepekimab and to check for any immune responses against the treatment.

  6. Step 6

    Completion of the study

    The study is expected to conclude by August 2026. Upon completion, the participant will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

4 criteria

  • Participant must be between 18 and 85 years old.
  • Have a clinical history that matches symptoms of **non-cystic fibrosis bronchiectasis (NCFB)**, such as a persistent cough, ongoing production of mucus, or frequent lung infections.
  • Have a **FEV1** (Forced Expiratory Volume in one second) that is at least 30% of what is predicted for a healthy person. This is a measure of how much air you can forcefully exhale in one second.
  • Have experienced at least 2 moderate or 1 severe **pulmonary exacerbations (PEs)** in the past year. A pulmonary exacerbation is a worsening of lung symptoms.

Who cannot join the trial?

10 criteria

  • Patients with a history of **cystic fibrosis**. Cystic fibrosis is a genetic disorder that affects the lungs and other organs.
  • Patients who have had a **lung transplant**. A lung transplant is a surgery to replace a diseased lung with a healthy one from a donor.
  • Patients with active **tuberculosis**. Tuberculosis is a serious infectious disease that mainly affects the lungs.
  • Patients with a history of **cancer** within the last 5 years, except for certain types of skin cancer. Cancer is a disease where cells in the body grow uncontrollably.
  • Patients with **HIV** infection. HIV is a virus that attacks the body's immune system.
  • Patients with **hepatitis B** or **hepatitis C**. These are viral infections that affect the liver.
  • Patients who are currently pregnant or breastfeeding. Pregnancy is the period during which a baby develops inside the mother's womb, and breastfeeding is feeding a baby with milk from the mother's breast.
  • Patients who have participated in another clinical trial within the last 30 days. A clinical trial is a research study to test new treatments.
  • Patients with a known allergy to the study medication or its ingredients. An allergy is a reaction by the immune system to something that is usually harmless.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Itepekimab is a medication being studied for its potential to help people with non-cystic fibrosis bronchiectasis. This condition involves damage to the airways in the lungs, leading to frequent lung infections and difficulty breathing. The trial aims to see if itepekimab can reduce the number of lung flare-ups, known as pulmonary exacerbations, in people with this condition. The study is designed to test how effective, safe, and well-tolerated itepekimab is for these patients.

What is already known about the treatment

Itepekimab – Itepekimab is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its potential use in treating non-cystic fibrosis bronchiectasis, a condition characterized by chronic lung infections and inflammation. The medication works by targeting and inhibiting specific proteins involved in the inflammatory process, which may help reduce lung exacerbations. Itepekimab is classified as a monoclonal antibody, a type of medication designed to interact with specific molecules in the body to modulate immune responses.

Investigated diseases

Bronchiectasis – This is a chronic lung condition where the airways become widened and scarred, leading to a build-up of mucus. This can cause frequent lung infections and persistent coughing. Over time, the airways lose their ability to clear out mucus, which can result in further lung damage. People with bronchiectasis often experience symptoms like shortness of breath, fatigue, and wheezing. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more severe respiratory issues. It is important to manage the condition to prevent further lung damage and maintain quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508663-70-00Protocol codeACT18018Estimated enrolment353 patientsSponsorSanofi-Aventis Recherche & Developpement

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