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Study on Itepekimab for Adults with Chronic Rhinosinusitis and Nasal Polyps

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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 condition known as chronic rhinosinusitis with nasal polyps. This is a long-term inflammation of the sinuses that leads to the growth of polyps, which are small, non-cancerous swellings inside the nose. The trial 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. In this case, itepekimab targets a protein called interleukin-33, which is involved in the inflammation process. The study will compare the effects of itepekimab to a placebo, which is a substance with no active medication, to see how well it works in reducing the size of nasal polyps and relieving nasal congestion.

The purpose of the study is to evaluate the effectiveness, safety, and tolerability of itepekimab in adults who have chronic rhinosinusitis with nasal polyps that are not well controlled. Participants in the study will receive either itepekimab or a placebo through an injection once a week for a total of 52 weeks, which is about one year. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to see if itepekimab can help reduce the symptoms of nasal polyps and improve the quality of life for those affected by this condition.

By participating in this study, researchers hope to gather important information about how itepekimab can help people with chronic rhinosinusitis with nasal polyps. This could lead to better treatment options in the future for those suffering from this condition. The study will also monitor any side effects or adverse reactions to ensure the safety of the participants. The results of this study could provide valuable insights into managing and treating chronic rhinosinusitis with nasal polyps more effectively.

The research process

The trial runs in 4 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, you will be randomly assigned to receive either the study medication, itepekimab, or a placebo. A placebo is a substance that looks like the study medication but does not contain the active ingredient.

    The study is designed to be 'double-blind,' meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    You will receive the medication as a solution for injection using a pre-filled syringe. The exact dosage and frequency will be determined by the study protocol and communicated to you by the study team.

    The treatment period will last for 52 weeks, during which you will continue to receive the injections at regular intervals as specified by the study team.

  3. Step 3

    Regular assessments

    Throughout the study, you will undergo regular assessments to monitor the size of your nasal polyps and the level of nasal congestion. These assessments will help determine the effectiveness of the treatment.

    You may also be asked to complete questionnaires about your symptoms and overall health. This information is important for evaluating the impact of the treatment on your quality of life.

  4. Step 4

    End of study

    At the end of the 52-week treatment period, you will have a final assessment to evaluate the overall effects of the treatment.

    The study team will discuss the results with you and provide information on any further steps or follow-up care that may be necessary.

Who can join the trial?

9 criteria

  • Participants must be 18 years of age or older.
  • Participants must have a history of chronic rhinosinusitis with nasal polyps for at least 1 year before joining the study. This means they have had long-term inflammation of the sinuses with growths in the nasal passages.
  • Participants must have at least one of the following:
    • Previous surgery on the sinuses for nasal polyps.
    • Worsening symptoms of chronic rhinosinusitis that required treatment with systemic corticosteroids (medications that reduce inflammation) within the last year.
    • Participants must have a Nasal Polyp Score of at least 5 out of 8, with at least 2 in each nasal cavity. This score is determined by a doctor using a small camera to look inside the nose.
    • Participants must have ongoing symptoms for at least 12 weeks before the first visit, including:
      • Nasal congestion (blocked or stuffy nose) that is moderate or severe at the first visit and has been more than mild in the week before the second visit.
      • At least one of the following: loss of smell or rhinorrhea (runny nose, either from the front or back of the nose).
      • Female participants must not be pregnant or breastfeeding. They must either:
        • Not be able to become pregnant, or
        • If they can become pregnant, agree to use a highly effective birth control method with less than 1% failure rate during the study and for at least 20 weeks after the last dose of the study medication.

Who cannot join the trial?

4 criteria

  • Patients who do not have chronic rhinosinusitis with nasal polyps cannot participate. This is a condition where the spaces inside your nose and head (sinuses) are swollen and have growths called polyps.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not provided here.
  • Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
  • Patients who do not meet other specific health criteria set by the study may be excluded. These criteria are not detailed here.
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Investigated drugs

Itepekimab is a medication being studied for its potential to help people with chronic rhinosinusitis who have nasal polyps. This condition can cause symptoms like a stuffy nose and difficulty breathing through the nose. Itepekimab works by targeting specific proteins in the body that are involved in inflammation, which is a part of the body's immune response. By reducing this inflammation, itepekimab may help to shrink the size of the nasal polyps and relieve nasal congestion, making it easier for patients to breathe and improving their overall quality of life. The trial aims to see how effective and safe itepekimab is for people who have not had enough relief from other treatments.

What is already known about the treatment

Itepekimab – Itepekimab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main use of itepekimab is to help treat chronic rhinosinusitis with nasal polyps, a condition where growths in the nasal passages cause congestion and discomfort. At the molecular level, itepekimab works by targeting specific proteins in the body that are involved in inflammation, helping to reduce the size of nasal polyps and ease nasal congestion. It belongs to a class of medications known as monoclonal antibodies, which are designed to target and neutralize specific substances in the body.

Investigated diseases

Chronic rhinosinusitis with nasal polyps – This condition involves long-term inflammation of the nasal passages and sinuses, leading to the growth of soft, painless, noncancerous masses called polyps. These polyps can cause nasal congestion, a reduced sense of smell, and a feeling of fullness in the face. Over time, the polyps can grow larger, potentially blocking nasal passages and making it difficult to breathe through the nose. The inflammation can also lead to mucus buildup, resulting in a runny nose or postnasal drip. The condition often occurs alongside other respiratory issues, such as asthma, and can be exacerbated by allergies or infections. Chronic rhinosinusitis with nasal polyps is a persistent condition that can significantly impact quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516815-26-00Protocol codeEFC18419Estimated enrolment382 patientsSponsorSanofi-Aventis Recherche & Developpement

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