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Study on Mepolizumab and Nasal Polypectomy for Patients with Chronic Rhinosinusitis

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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 rhinosinusitis (CRS), a condition where the sinuses become swollen and inflamed for a long time, often with nasal polyps, which are non-cancerous growths in the nose. The study will explore the effects of a treatment called mepolizumab, also known by its code name SB240563, which is given as an injection. Mepolizumab is a type of medication that targets specific proteins in the body to help reduce inflammation.

The purpose of the study is to see if mepolizumab can improve the quality of life for people with CRS, as measured by a questionnaire called the sinonasal outcome test (SNOT-22). Participants in the study will be divided into three groups. Some will receive mepolizumab, while others may undergo a procedure called nasal polypectomy, which is a minor surgery to remove polyps from the nose. There is also a possibility of receiving a placebo, which is a substance with no active medication. The study will monitor participants over a period of time to assess changes in their symptoms and overall well-being.

Throughout the study, various aspects will be evaluated, such as nasal symptoms, the need for additional treatments like corticosteroids, and any potential side effects of the treatment. The safety of mepolizumab will be closely monitored by collecting information on any adverse events during the study visits. The trial aims to provide valuable insights into how effective mepolizumab is in managing chronic rhinosinusitis with nasal polyps and improving patients' lives.

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, eligibility is confirmed based on specific criteria, including age, diagnosis of chronic rhinosinusitis with nasal polyps, and other health indicators.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the baseline condition. This includes a sino-nasal outcome test (SNOT-22) to measure quality of life related to nasal symptoms.

    Additional assessments may include a visual analog scale (VAS) score for nasal symptoms and examination using a nasopharyngoscope.

  3. Step 3

    Treatment administration

    The treatment involves the administration of mepolizumab, a medication given as a subcutaneous injection. The specific dosage is 100 mg, provided in a pre-filled syringe.

    The frequency and duration of the treatment are determined by the study protocol and will be communicated during the trial.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes repeated SNOT-22 tests and other evaluations as needed.

    The need for any additional treatments, such as rescue therapy with systemic corticosteroids or surgery, is evaluated during the study.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to evaluate the overall outcomes and any changes in symptoms or quality of life.

    The results are compared to the initial assessments to determine the effectiveness of the treatment.

Who can join the trial?

10 criteria

  • Participant must be **18 years of age or older**.
  • Must have a diagnosis of **chronic rhinosinusitis (CRS) with nasal polyps**. This means having two or more symptoms for at least 12 weeks, such as nasal blockage, nasal discharge, facial pain, or loss of smell, along with signs of nasal polyps or changes seen in a CT scan.
  • Must be suitable for **biologic treatment** as per specific guidelines. This includes having bilateral polyps and meeting three of the following criteria:
    • Evidence of **type 2 inflammation**, which can be shown by certain blood or tissue tests.
    • Need for **systemic corticosteroids** (a type of medication) or having a reason not to use them.
    • Significantly **impaired quality of life**.
    • Significant **loss of smell**.
    • Diagnosis of **comorbid asthma** (having asthma along with CRS).
    • For patients who have not had surgery and are not fit for it, or those who have had surgery and the condition has returned, a **basal eosinophil count** of 300 cells/µL or more is required. Eosinophils are a type of white blood cell.
    • Patients must be informed about the study and must **sign a consent form** to participate.
    • For patients not suitable for surgery, specific criteria for biological treatment will be used, including a basal eosinophil count of 300 cells/µL or more.

Who cannot join the trial?

3 criteria

  • Patients who have a different condition than chronic rhinosinusitis (CRS) cannot participate. CRS is a long-term inflammation of the sinuses and nasal passages.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, like children or the elderly.
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Investigated drugs

  • Mepolizumab

    is a medication used in this trial to help reduce inflammation in patients with chronic rhinosinusitis. It works by targeting specific proteins in the body that contribute to inflammation, which can help decrease the size of nasal polyps and improve breathing and overall quality of life.

  • In-office nasal polypectomy

    is a procedure performed in a medical office setting to remove nasal polyps. This therapy is used to physically eliminate the polyps that can block nasal passages, helping to improve airflow and reduce symptoms associated with chronic rhinosinusitis.

What is already known about the treatment

Mepolizumab – Mepolizumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating chronic rhinosinusitis (CRS), particularly in patients undergoing nasal polypectomy. The main therapeutic indication for Mepolizumab is to improve the quality of life for individuals with CRS, as measured by the sinonasal outcome test (SNOT-22). At the molecular level, Mepolizumab works by targeting and inhibiting interleukin-5 (IL-5), a protein involved in the inflammatory process, thereby reducing inflammation and symptoms associated with CRS. It is classified as a monoclonal antibody in pharmacology.

Investigated diseases

Chronic Rhinosinusitis – Chronic rhinosinusitis is a long-lasting inflammation of the nasal passages and sinuses. It is characterized by nasal congestion, facial pain or pressure, and a reduced sense of smell. The condition can lead to the formation of nasal polyps, which are non-cancerous growths in the nasal passages or sinuses. Symptoms often persist for more than 12 weeks despite treatment attempts. The inflammation can be caused by infections, allergies, or other factors that irritate the nasal passages. Over time, chronic rhinosinusitis can significantly impact a person's quality of life due to persistent discomfort and breathing difficulties.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505426-34-01Protocol codeMELYSAEstimated enrolment75 patientsSponsorInstituto De Investigacion Marques De Valdecilla

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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).