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Study on Long-Term Safety of Itepekimab for Patients with 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 the long-term safety and tolerability of a treatment called itepekimab in individuals with Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic lung disease that makes it difficult to breathe and can lead to coughing, wheezing, and shortness of breath. The treatment being tested, itepekimab, is a solution for injection that is administered using a pre-filled syringe. It is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body that may contribute to inflammation and other symptoms associated with COPD.

The purpose of this study is to evaluate how safe and well-tolerated itepekimab is over a longer period in people who have already participated in previous studies involving this treatment. Participants in this study will have previously completed a treatment period in one of two earlier clinical studies. During the study, participants will receive either itepekimab or a matched placebo, which is a substance that looks like the treatment but does not contain the active ingredient. The study will monitor participants for any side effects or reactions to the treatment, as well as measure the levels of itepekimab in the blood.

Throughout the study, researchers will also observe how often participants experience flare-ups of their COPD symptoms, known as acute exacerbations, and how long it takes for these flare-ups to occur. Additionally, changes in lung function and quality of life from the baseline of the previous studies will be assessed. The study aims to provide valuable information on the long-term use of itepekimab in managing COPD symptoms and improving patient outcomes.

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

    Enrollment

    Eligibility for the study requires completion of a previous itepekimab COPD Phase 3 clinical study, specifically EFC16750 or EFC16819.

    The end-of-treatment visit from the previous study must have occurred no later than 3 days before the enrollment visit for this study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and confirm eligibility for the study.

    This assessment includes reviewing medical history and any recent changes in health.

  3. Step 3

    Treatment administration

    The treatment involves the administration of itepekimab, a solution for injection provided in a pre-filled syringe.

    The medication is administered subcutaneously, which means it is injected under the skin.

    The frequency and dosage of the medication are determined by the study protocol and are administered by healthcare professionals.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the long-term safety and tolerability of itepekimab.

    This includes tracking any side effects or adverse events that may occur during the study period.

    Follow-up visits are scheduled to evaluate the patient's response to the treatment and to make any necessary adjustments.

  5. Step 5

    Completion of study

    The study is estimated to conclude by December 1, 2026.

    Upon completion, a final assessment is conducted to evaluate the overall health status and any changes observed during the study.

Who can join the trial?

5 criteria

  • Must have **Chronic Obstructive Pulmonary Disease (COPD)**, which is a long-term lung condition that makes it hard to breathe.
  • Must have completed the treatment period in a previous study with the medicine **itepekimab** for COPD. This means you were part of a specific earlier study and finished the treatment there.
  • The end-of-treatment visit in the previous study must have happened no more than 3 days before joining this new study.
  • Both men and women can participate.
  • Participants should not be from a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who cannot join the trial?

3 criteria

  • Participants who have not been part of previous studies involving the medication itepekimab for **Chronic Obstructive Pulmonary Disease (COPD)**. COPD is a lung condition that makes it hard to breathe.
  • Individuals who are not within the specified age range for the study. The study is looking for participants in certain age groups.
  • People who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Itepekimab is a medication being studied for its long-term safety and tolerability in patients with chronic obstructive pulmonary disease (COPD). It is intended for individuals who have already participated in previous clinical studies involving itepekimab. The goal is to understand how well patients can tolerate this medication over an extended period and to ensure it is safe for long-term use in managing COPD symptoms.

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 long-term safety and tolerability in patients with chronic obstructive pulmonary disease (COPD). The main therapeutic indication for itepekimab is to help manage symptoms of moderate to severe COPD. At the molecular level, itepekimab works by targeting and inhibiting specific proteins involved in inflammation, which may help reduce lung inflammation and improve breathing. It is classified as a monoclonal antibody, a type of medication designed to target specific molecules in the body.

Investigated diseases

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease, commonly known as COPD, is a long-term lung condition that makes it difficult to breathe. It is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. The disease progresses slowly and is often caused by significant exposure to harmful particles or gases, most commonly from smoking. Over time, individuals with COPD may experience increased breathlessness, frequent coughing, and production of mucus. The condition can lead to episodes of worsening symptoms known as exacerbations, which can further impact lung function. COPD is a progressive disease, meaning it typically worsens over time, affecting the quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508085-15-00Protocol codeLTS18133Estimated enrolment722 patientsSponsorSanofi-Aventis Recherche & Developpement

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