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Study on Mepolizumab and Drug Combination for Patients with Eosinophilic Granulomatosis with Polyangiitis

Fast replyRegistered drugNo 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 Eosinophilic Granulomatosis with Polyangiitis (EGPA), which was previously called Churg-Strauss syndrome. EGPA is a rare disease that causes inflammation of blood vessels, leading to damage in various organs. The study aims to evaluate the effectiveness of a treatment regimen based on Mepolizumab, a medication that helps reduce inflammation by targeting specific cells in the immune system. This regimen will be compared to a conventional treatment strategy to see if it can help patients achieve remission, which means a reduction or disappearance of disease symptoms.

Participants in the study will receive either the Mepolizumab-based treatment or a conventional treatment, which may include medications like Cyclophosphamide and Azathioprine. Cyclophosphamide is a medication used to suppress the immune system, while Azathioprine is often used to prevent the body from rejecting transplanted organs and to treat autoimmune diseases. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will monitor the participants over a period to assess the impact of these treatments on their condition.

The main goal of the study is to determine if the Mepolizumab-based regimen can reduce the need for glucocorticoids, a type of steroid medication, in patients with newly diagnosed or relapsing EGPA. The study will track the dosage of a specific glucocorticoid called prednisone, aiming for a dose of 4.0 mg or less per day by a certain point in the study. Participants will be closely monitored for any changes in their condition, including any relapses or flare-ups of symptoms, as well as any side effects from the treatments. The study will provide valuable information on the potential benefits of Mepolizumab for managing EGPA.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) and ensuring the patient is 18 years or older.

    The assessment also checks for active disease status, defined by a Birmingham Vasculitis Activity Score (BVAS) of 3 or higher.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications. Patients receive either a mepolizumab-based regimen or a conventional therapeutic strategy.

    Mepolizumab is administered as a subcutaneous injection. The dosage and frequency are determined by the study protocol.

  3. Step 3

    Medication regimen

    Patients may receive cyclophosphamide or azathioprine as part of the conventional treatment strategy. Cyclophosphamide is given by injection, while azathioprine is taken orally in the form of film-coated tablets.

    Sodium chloride may be used as a solution for injection, and a placebo for azathioprine is also part of the study.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment. This includes measuring the prednisone dosage at specific intervals, such as days 168 and 364.

    The study aims to achieve a prednisone dose of 4.0 mg or less per day by day 168 without relapse.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the percentage of patients achieving the target prednisone dose without relapse.

    Secondary outcomes include the number of relapses, asthma and sinonasal exacerbations, and adverse events during the study period.

  6. Step 6

    Completion of study

    The study is expected to conclude by January 30, 2026. Final evaluations will be conducted to assess the long-term effects of the treatment strategies.

Who can join the trial?

6 criteria

  • Patients must have a diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA), regardless of their ANCA status. ANCA refers to a type of antibody that can be found in some people with this condition.
  • Patients must be aged 18 years or older.
  • Patients must have either newly-diagnosed or relapsing disease at the time of screening, with active disease defined by a Birmingham Vasculitis Activity Score (BVAS) of 3 or higher. BVAS is a way to measure how active the disease is.
  • Patients must be within the first 21 days after starting or increasing corticosteroids at a dose of 1 mg per kg per day or less. Corticosteroids are a type of medication used to reduce inflammation. Pulses of methylprednisolone, a specific corticosteroid, before starting oral corticosteroid therapy are allowed.
  • Patients must provide written informed consent before participating in the study. This means they agree to take part after being informed about the study details.
  • Patients must be affiliated with social security or CMU, either as a beneficiary or assignee. This means they should have some form of health coverage or insurance.

Who cannot join the trial?

5 criteria

  • Patients who have a different medical condition other than eosinophilic granulomatosis with polyangiitis (EGPA), which is a rare disease that causes inflammation of blood vessels.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have any other health issues that might interfere with the study or make it unsafe for them to participate.
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Investigated drugs

  • Mepolizumab

    is a medication used in this trial to help reduce the need for glucocorticoids, like prednisone, in patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA). It works by targeting and reducing the activity of certain immune cells that contribute to inflammation and symptoms in EGPA.

  • Prednisone

    is a type of glucocorticoid, which is a steroid medication used to reduce inflammation in the body. In this trial, it is used as part of the conventional therapeutic strategy to manage symptoms of EGPA. The study aims to see if using mepolizumab can help patients use less prednisone while still controlling their condition.

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 eosinophilic granulomatosis with polyangiitis (EGPA), a rare condition that causes inflammation of blood vessels. The main therapeutic indication for mepolizumab is to reduce the need for glucocorticoids, such as prednisone, in managing EGPA. At the molecular level, mepolizumab works by targeting and inhibiting interleukin-5 (IL-5), a protein that plays a key role in the growth and activation of eosinophils, which are a type of white blood cell involved in inflammation. Mepolizumab is classified as a monoclonal antibody, which is a type of biologic medication designed to target specific proteins in the body.

Investigated diseases

Eosinophilic Granulomatosis with Polyangiitis (EGPA) – This is a rare disease characterized by inflammation of small to medium-sized blood vessels, which can affect various organs. It often begins with asthma and allergic rhinitis, followed by an increase in eosinophils, a type of white blood cell. As the disease progresses, it can lead to symptoms such as skin rashes, nerve pain, and gastrointestinal issues. The inflammation can cause damage to organs like the lungs, heart, and kidneys. EGPA is known for its relapsing and remitting nature, meaning symptoms can improve and then worsen over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513653-75-00Protocol codeD20180135Estimated enrolment100 patientsSponsorAssistance Publique Hopitaux De Paris

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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).