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Study on the Effects of Itepekimab for Patients with Chronic Rhinosinusitis Without Nasal Polyps

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 a condition known as chronic rhinosinusitis without nasal polyps, which is a long-term inflammation of the sinuses that does not involve growths called polyps. The study 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 this study is to evaluate how effective itepekimab is compared to a placebo in reducing sinus inflammation. Participants in the study will receive either itepekimab or a placebo through an injection under the skin. The study will last for a period of up to 24 weeks, during which participants will have regular check-ups to monitor their condition and any changes in their symptoms. The main focus will be on changes in the amount of sinus blockage, as seen on a CT scan, which is a type of imaging test that helps doctors see inside the body.

Throughout the study, participants will also be asked to keep track of their symptoms, such as nasal congestion, runny nose, facial pain, and loss of smell, using a daily electronic diary. The study will also monitor the safety and tolerability of itepekimab, looking for any side effects or reactions to the treatment. This research aims to provide more information on how well itepekimab works for people with chronic rhinosinusitis without nasal polyps and to ensure it is safe for use.

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 assessment

    The trial begins with an initial assessment to confirm eligibility. This includes checking symptoms of nasal congestion and sinus issues, as well as reviewing medical history related to chronic rhinosinusitis.

    A CT scan is performed to assess sinus opacification, ensuring at least 25% opacification in specific sinus areas.

  2. Step 2

    Baseline evaluation

    Participants undergo a baseline evaluation to record initial symptoms and scores, such as the Sino-Nasal Outcome Test-22 (SNOT-22) and Total Symptom Score (sTSS).

    The use of mometasone furoate nasal spray is confirmed to be stable for at least three weeks prior to this evaluation.

  3. Step 3

    Randomization and treatment

    Participants are randomly assigned to receive either the study medication, itepekimab, or a placebo. Both are administered as a subcutaneous injection using a pre-filled syringe.

    The treatment phase involves regular administration of the assigned injection, with the frequency and duration specified by the study protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, participants are monitored for changes in symptoms and any side effects. This includes regular assessments of nasal congestion, rhinorrhea, facial pain, and loss of smell.

    Participants maintain a daily electronic diary to record symptom severity and any adverse events.

  5. Step 5

    Final assessment

    At the end of the treatment period, a final assessment is conducted to evaluate changes from baseline in sinus opacification and symptom scores.

    The presence of any treatment-emergent adverse events and the concentration of itepekimab in the serum are also assessed.

Who can join the trial?

11 criteria

  • Participant must be 18 years of age or older.
  • Participants must have ongoing symptoms of nasal congestion or blockage for at least 12 consecutive weeks before the first visit and a Nasal Congestion Score (NCS) of 2 or more at the first and second visits. The NCS is a way to measure how blocked your nose feels.
  • Participants must have a sinus Total Symptom Score (sTSS) of 5 or more at the first and second visits. This score includes symptoms like nasal congestion, runny nose, and facial pain or pressure.
  • Participants must have at least one of the following:
    • Previous sinus surgery for chronic rhinosinusitis (CRS), which is a long-term inflammation of the sinuses.
    • Treatment with systemic corticosteroids (SCS) in the last 2 years before the first visit. SCS are medications that reduce inflammation throughout the body.
    • Worsening symptoms of CRS in the past 2 years that would have needed treatment with SCS, but the participant cannot take SCS due to intolerance or other health reasons.
    • Participants must have inflammation in both sides of the paranasal sinuses, with at least 25% blockage in the ethmoid sinuses and at least one maxillary sinus as seen on a CT scan. The paranasal sinuses are air-filled spaces around the nose, and the ethmoid and maxillary sinuses are specific areas within them.
    • Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT-22) score of 20 or more at the first and second visits. This test measures the impact of sinus problems on daily life.
    • Participants must have been using a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before the second visit. This is a nasal spray used to reduce inflammation in the nose.
    • A female participant is eligible if she is not pregnant or breastfeeding and meets one of the following conditions:
      • She is not a woman of childbearing potential (WOCBP).
      • She is a WOCBP and agrees 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 treatment.

Who cannot join the trial?

4 criteria

  • Patients with certain **respiratory tract diseases** cannot participate. This refers to illnesses affecting the parts of the body involved in breathing, like the lungs and airways.
  • Individuals who do not fall within the specified age range for the study are excluded. This means only people of certain ages can join the trial.
  • Participants who are not part of the specified clinical trial groups are not eligible. This refers to specific categories or groups of people the study is focusing on.
  • People who are considered part of a **vulnerable population** are excluded. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Itepekimab is a medication being studied for its potential to help people with chronic rhinosinusitis who do not have nasal polyps. This condition involves inflammation of the sinuses, leading to symptoms like nasal congestion and facial pain. The trial aims to see if itepekimab can reduce the blockage in the sinuses, which is often seen in this condition.

What is already known about the treatment

Itepekimab – This medication is administered via injection and is currently being studied in clinical trials for its potential use in treating respiratory tract diseases, specifically chronic rhinosinusitis without nasal polyps. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for itepekimab is to improve sinus opacification in patients whose condition is not adequately controlled. At the molecular level, itepekimab works by targeting specific pathways involved in inflammation, helping to reduce symptoms associated with the disease. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Chronic Rhinosinusitis – This condition involves inflammation of the sinuses and nasal passages, leading to symptoms such as nasal congestion, facial pain or pressure, and a reduced sense of smell. It can cause the sinuses to become blocked with fluid, resulting in sinus opacification visible on imaging tests like CT scans. Over time, the persistent inflammation can lead to the thickening of the sinus lining and the formation of nasal polyps. The condition is often chronic, meaning it can last for several weeks or longer, and may recur frequently. It can significantly impact quality of life due to ongoing discomfort and difficulty breathing through the nose.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515576-12-00Protocol codeACT18421Estimated enrolment109 patientsSponsorSanofi-Aventis Recherche & Developpement

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