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Study on the Effects of Itepekimab in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

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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 Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes it hard to breathe. The study is testing 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 help the immune system fight diseases. In this study, itepekimab is given as a solution for injection using a pre-filled syringe. The purpose of the study is to evaluate how well itepekimab works compared to a placebo in reducing the number of flare-ups, or exacerbations, in people with moderate-to-severe COPD who used to smoke.

Participants in the study will receive either itepekimab or a placebo. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are not biased. The study will last for about a year, during which participants will receive regular injections and attend scheduled visits to monitor their health and the effects of the treatment. The researchers will be looking at how often participants experience COPD exacerbations, which are episodes where symptoms suddenly get worse and may require additional treatment.

Throughout the study, various health assessments will be conducted to ensure the safety and well-being of the participants. These assessments will include checking lung function, monitoring any side effects, and evaluating overall respiratory symptoms. The study aims to provide valuable information on the effectiveness and safety of itepekimab as a potential treatment for COPD, which could lead to improved management of this challenging condition.

The research process

The trial runs in 5 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 informed about the trial's purpose, which is to evaluate the effectiveness and safety of itepekimab in treating chronic obstructive pulmonary disease (COPD).

    The participant will be randomly assigned to receive either itepekimab or a 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 the administration of itepekimab or a placebo through a subcutaneous injection. This means the injection is given under the skin.

    The medication is provided in a pre-filled syringe, ensuring accurate dosage and ease of use.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, the participant's health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to track any changes in symptoms or side effects.

    The primary goal is to observe the annualized rate of moderate or severe acute exacerbations of COPD, which are episodes where symptoms suddenly worsen.

  4. Step 4

    Evaluation of results

    The study will also evaluate secondary outcomes, such as changes in lung function and respiratory symptoms, using tests like the forced expiratory volume in 1 second (FEV1) and questionnaires.

    The participant's experience with the treatment, including any adverse effects, will be documented to assess the overall safety and tolerability of itepekimab.

  5. Step 5

    Completion of the study

    The study is expected to conclude by November 2025. At the end of the trial, the collected data will be analyzed to determine the effectiveness of itepekimab in managing COPD.

    Participants will be informed about the study's findings and any potential implications for future COPD treatments.

Who can join the trial?

9 criteria

  • Participant must be between 40 and 85 years old.
  • Must have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) for at least 1 year. COPD is a lung condition that makes it hard to breathe.
  • Must have a history of smoking at least 10 pack-years. This means the number of packs of cigarettes smoked per day multiplied by the number of years the person has smoked. They must have quit smoking at least 6 months before the study starts and intend to quit permanently.
  • Must have moderate-to-severe COPD.
  • Must have a history of chronic bronchitis, which means having a long-term cough that produces mucus for at least 3 months in the year before the study, and other causes of cough have been ruled out.
  • Must have a history of high risk for exacerbations, which are flare-ups of COPD symptoms. This means having at least 2 moderate or 1 severe exacerbations in the year before the study, with at least one treated with systemic corticosteroids. Moderate exacerbations require medication like corticosteroids or antibiotics, while severe ones require hospital care.
  • Must be on a stable dose of standard COPD treatment for at least 1 month before the study. This includes combinations of inhaled medications like corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists.
  • Must have a Body Mass Index (BMI) of at least 18.0 kg/m², or at least 16.0 kg/m² for participants from East-Asian countries. BMI is a measure of body fat based on height and weight.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for at least 20 weeks after the last dose of the study medication.

Who cannot join the trial?

7 criteria

  • Patients who have a history of other serious lung diseases besides Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe.
  • Patients who have had a recent lung infection or flare-up of their COPD symptoms.
  • Patients who are currently smoking or have smoked recently. The study is for former smokers.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

SAR440340/REGN3500/itepekimab is a medication being studied for its potential to help people with moderate-to-severe chronic obstructive pulmonary disease (COPD). It is an antibody that targets a specific protein in the body called IL-33, which is thought to play a role in inflammation. By blocking this protein, itepekimab may help reduce the number of flare-ups or worsening of symptoms in people with COPD. This study aims to see how well itepekimab works and how safe it is for patients who have previously smoked and are dealing with this condition.

What is already known about the treatment

Itepekimab – Itepekimab is administered as an injection and is currently being studied in clinical trials for its potential use in treating chronic obstructive pulmonary disease (COPD). It is in the Phase 3 stage of clinical trials, which means it is being tested for efficacy, safety, and tolerability in a larger group of patients. The main therapeutic indication for itepekimab is to reduce the frequency of acute exacerbations in patients with moderate-to-severe COPD. It works by targeting and inhibiting the activity of interleukin-33 (IL-33), a protein involved in inflammatory processes, thereby potentially reducing inflammation in the lungs. Itepekimab is classified as a monoclonal antibody, which is a type of biologic drug designed to target specific molecules in the body.

Investigated diseases

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung condition that causes breathing difficulties. It is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. The disease progresses with increasing breathlessness, frequent coughing, and production of mucus. Over time, individuals may experience exacerbations, which are episodes where symptoms become worse than the usual day-to-day variation. These exacerbations can be triggered by infections or environmental pollutants. COPD is commonly associated with a history of smoking or exposure to harmful particles and gases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512013-41-00Protocol codeEFC16750Estimated enrolment2 401 patientsSponsorSanofi-Aventis Recherche & Developpement

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