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Study on Itepekimab for Former Smokers with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Fast replyInvestigationalNo placebo
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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 condition that affects the lungs and makes it difficult 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 being compared to a placebo to see how well it works in reducing the number of flare-ups or worsening of symptoms in people with moderate-to-severe COPD who used to smoke.

The purpose of the study is to evaluate the effectiveness, safety, and how well patients tolerate Itepekimab. Participants in the study will receive either Itepekimab or a placebo through an injection under the skin. The study will last for about a year, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to find out if Itepekimab can help reduce the frequency of COPD flare-ups and improve lung function over time.

Throughout the study, researchers will also look at other aspects such as changes in breathing tests, the time it takes for the first flare-up to occur, and any side effects that may arise. This information will help determine if Itepekimab is a safe and effective treatment option for people with COPD. Participants will be closely monitored to ensure their safety and well-being throughout the study period.

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 randomly assigned to receive either the test medication, itepekimab, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The medication, itepekimab, is administered as a solution for injection using a pre-filled syringe. The route of administration is subcutaneous, which means the injection is given under the skin.

    The frequency and dosage of the medication 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, participants will undergo regular monitoring to assess the efficacy and safety of the treatment. This includes measuring the annualized rate of acute moderate or severe exacerbations of chronic obstructive pulmonary disease (COPD).

    Additional assessments will include changes in lung function, specifically the forced expiratory volume in one second (FEV1), and the evaluation of respiratory symptoms using standardized questionnaires.

  4. Step 4

    Safety evaluations

    Participants will be monitored for any adverse events, including treatment-emergent adverse events, serious adverse events, and any events leading to discontinuation of the treatment.

    Regular laboratory tests, vital signs, and electrocardiograms (ECGs) will be conducted to ensure participant safety.

  5. Step 5

    Study completion

    The study is expected to conclude by September 2025. Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment on their COPD condition.

Who can join the trial?

11 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 smoking one pack of cigarettes per day for 10 years or an equivalent amount.
  • For former smokers, they must have quit smoking at least 6 months before the start of the study and intend to quit permanently.
  • For current smokers, they must be smoking at least one cigarette per day and not planning to quit during the study period.
  • Must have moderate-to-severe COPD.
  • Must have a history of chronic bronchitis, which is a long-term cough with mucus lasting at least 3 months in the past year, and other causes of cough have been ruled out.
  • Must have a history of high risk for COPD flare-ups, defined as having at least 2 moderate or 1 severe flare-ups in the past year. A moderate flare-up is a sudden worsening of symptoms needing medication, and a severe flare-up requires hospital care.
  • Must be on a stable dose of standard COPD treatment for at least 1 month before the study. This includes medications like inhaled corticosteroids, long-acting beta-agonists, or 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 20 weeks after the last dose of the study medication.
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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 is focused on understanding how effective and safe itepekimab 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, typically under the skin. It is currently being studied in clinical trials for its potential use in treating chronic obstructive pulmonary disease (COPD). The main therapeutic indication for itepekimab is to reduce the frequency of acute exacerbations in patients with moderate-to-severe COPD. At the molecular level, itepekimab works by targeting and inhibiting the activity of interleukin-33 (IL-33), a protein involved in inflammatory processes. It is classified as a monoclonal antibody, specifically an anti-IL-33 monoclonal antibody.

Investigated diseases

Chronic Obstructive Pulmonary Disease – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, leading to breathing difficulties. The disease progresses slowly and is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. Over time, individuals with COPD may experience worsening symptoms, including increased breathlessness, frequent coughing, and mucus production. The disease can lead to episodes of exacerbations, where symptoms become more severe for a period. COPD is not fully reversible, and its progression can vary among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512012-21-00Protocol codeEFC16819Estimated enrolment1 501 patientsSponsorSanofi-Aventis Recherche & Developpement

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).