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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 nasal passages. 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. Itepekimab is designed to target and block a protein called interleukin-33, which is involved in the inflammation process.

The purpose of the study is to evaluate how effective itepekimab is in reducing the size of nasal polyps and relieving nasal congestion compared to a placebo. Participants in the study will receive either itepekimab or a placebo through a subcutaneous injection, which means the medication is injected under the skin. The study will last for 52 weeks, during which participants will be monitored for changes in their symptoms and any side effects they might experience.

Throughout the study, participants will undergo various assessments to track their progress. These assessments will include checking the size of the nasal polyps and the level of nasal congestion. The study will also look at other symptoms like loss of smell and sinus opacification, which refers to the cloudiness seen in the sinuses on a computed tomography (CT) scan. The trial aims to provide valuable information on the safety and effectiveness of itepekimab for people with chronic rhinosinusitis with nasal polyps.

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

    Initial visit and screening

    Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Participants must have a history of chronic rhinosinusitis with nasal polyps for at least one year and meet specific criteria related to nasal symptoms and previous treatments.

  2. Step 2

    Randomization and baseline assessment

    Participants are randomly assigned to receive either the study medication, itepekimab, or a placebo (a substance with no active medication).

    Baseline assessments are conducted, including an endoscopic examination to score nasal polyps and evaluate nasal congestion.

  3. Step 3

    Treatment phase

    Participants receive the assigned treatment through a subcutaneous injection (an injection under the skin) using a pre-filled syringe.

    The treatment is administered regularly over a period of 52 weeks. The exact frequency and dosage are determined by the study protocol.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor the participant's health and response to the treatment.

    These visits include assessments of nasal polyp size, nasal congestion, and other related symptoms. Additional tests, such as CT scans, may be conducted to evaluate sinus opacification.

  5. Step 5

    Final assessment and study completion

    At the end of the 52-week treatment period, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

    Participants may be asked to complete questionnaires about their symptoms and quality of life. The study team will review all collected data to assess the outcomes.

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, as seen through an endoscope (a small camera used 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 a weekly average severity greater than 1 in the week before the second visit.
      • At least one of the following symptoms: 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 of childbearing potential, or
        • If they are of childbearing potential, they must agree to use a highly effective contraceptive method with a failure rate of less than 1% during the study and for at least 20 weeks after the last dose of the study medication.

Who cannot join the trial?

9 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 study is for adults and children of certain ages.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had recent surgery or plan to have surgery during the study cannot participate.
  • Patients who have a history of certain allergies or reactions to medications cannot participate.
  • Patients who have used certain medications recently that might interfere with the study cannot participate.
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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. This trial is designed to see how effective and safe itepekimab is for people who have not had success with other treatments for their condition.

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 the nasal passages become inflamed and swollen. It works by targeting specific proteins in the body that contribute to inflammation, helping to reduce the size of nasal polyps and relieve nasal congestion. Itepekimab is classified as a monoclonal antibody, a type of medication designed to interact with the immune system.

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 block nasal passages, causing breathing difficulties, a reduced sense of smell, and nasal congestion. The inflammation is persistent and can result in a thickened sinus lining and increased mucus production. Over time, the condition can lead to frequent sinus infections and a feeling of pressure in the face. The presence of nasal polyps is often associated with other conditions like asthma or aspirin sensitivity. The disease progresses with fluctuating symptoms, often worsening over time without intervention.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516814-39-00Protocol codeEFC18418Estimated enrolment382 patientsSponsorSanofi-Aventis Recherche & Developpement

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