Study on the Effects of Mepolizumab on Nasal Health and Immune Response in Patients with Eosinophilic Granulomatosis with Polyangiitis (eGPA)

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What is this study about?

This clinical trial is focused on studying a condition called eosinophilic granulomatosis with polyangiitis (eGPA). This is a rare disease that causes inflammation of blood vessels, which can lead to damage in various organs. The study will use a treatment called mepolizumab, which is given as an injection under the skin. Mepolizumab is a type of protein that helps to reduce inflammation by targeting specific cells in the immune system.

The purpose of the study is to see how mepolizumab affects the nasal microbiome, which is the community of bacteria and other microorganisms living in the nose, and the immune response in people with eGPA. Participants in the study will receive mepolizumab treatment, and researchers will observe changes in the nasal microbiome and immune response over time. The study will last for a period of 36 months, with regular check-ups to monitor the effects of the treatment.

By participating in this study, researchers hope to better understand how mepolizumab can help restore a healthy balance of microorganisms in the nose and improve the immune response in patients with eGPA. This could lead to better treatment options for managing the disease in the future.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will need to provide informed consent, which means you agree to participate after understanding the study details.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This may include a review of your medical history and specific tests to ensure you meet the criteria for participation.

3 treatment phase

During the treatment phase, you will receive the medication mepolizumab. This medication is administered through a subcutaneous injection, which means it is given under the skin.

The dosage and frequency of the medication will be explained to you by the study team. The treatment will last for a period of three months.

4 monitoring and follow-up

Throughout the study, regular monitoring will be conducted to observe the effects of the treatment. This may include visits to the study site for check-ups and tests.

The primary focus will be on how the treatment affects the nasal microbiome, which refers to the community of microorganisms in the nasal area.

5 end of study

At the end of the study, a final assessment will be conducted to evaluate the overall impact of the treatment.

You will be informed about the results and any further steps, if necessary.

Who Can Join the Study?

Must be over 18 years old.
Must be able to give informed consent, meaning you understand the study and agree to participate.
If you have Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), you need to have nasal polyps on both sides of your nose, confirmed by a doctor using a camera or a special scan.
If you have Severe Asthma, you need a doctor’s diagnosis of asthma with a breathing test result (FEV1) less than 80% of normal, and either a breathing test that improves by more than 12% after treatment or a positive result on a special breathing challenge test.
If you have Eosinophilic Granulomatosis with Polyangiitis (eGPA), you must meet specific criteria set by experts in 2022.
If you have Granulomatosis with Polyangiitis (GPA), you must meet specific criteria set by experts in 2022.
If you are a healthy control, you should not have asthma symptoms or a condition where your airways are overly sensitive.

Who Cannot Join the Study?

Patients with any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have received any other investigational drug within the last 30 days.
Patients with a history of severe allergic reactions to any medication.
Patients who have been diagnosed with any other autoimmune disease, which is when the body’s immune system attacks its own healthy cells.
Patients who have a history of cancer, except for certain types of skin cancer that have been treated successfully.
Patients who have a history of drug or alcohol abuse within the past year.
Patients who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Ueltrezohmqd Mzsffoo Ccfxouz Gylocpnac	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Mepolizumab

Mepolizumab is a medication used in this clinical trial to help treat a condition called eosinophilic granulomatosis with polyangiitis (eGPA). This condition involves inflammation of blood vessels and can affect various parts of the body, including the nose. Mepolizumab works by targeting and reducing the number of eosinophils, which are a type of white blood cell that can cause inflammation and damage when present in high numbers. By reducing these cells, Mepolizumab aims to improve symptoms and restore a healthier balance in the nasal area, potentially leading to a more normal nasal microbiome and a better immune response both locally and throughout the body.

Investigated diseases:

Eosinophilic granulomatosis with polyangiitis

Eosinophilic Granulomatosis with Polyangiitis (eGPA) – Eosinophilic Granulomatosis with Polyangiitis is a rare autoimmune disease characterized by inflammation of small to medium-sized blood vessels. 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 affect various organs, including the lungs, skin, and nerves. Patients may experience symptoms such as fatigue, weight loss, and muscle or joint pain. The disease can lead to the formation of granulomas, which are small areas of inflammation. Over time, the inflammation can cause damage to the affected organs.

Trial ID:

2023-508029-28-00

Protocol code:

NL83176.042.23

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Mepolizumab on Nasal Health and Immune Response in Patients with Eosinophilic Granulomatosis with Polyangiitis (eGPA)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?