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Study on Benralizumab and Mepolizumab for Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) Receiving Standard Care

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What is this study about?

This clinical trial is focused on studying a condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA). EGPA is a rare disease that causes inflammation of blood vessels, which can lead to damage in various organs. The study is comparing the effectiveness and safety of two treatments: Benralizumab and Mepolizumab. Both of these are medications given by injection and are designed to help reduce inflammation by targeting specific cells in the immune system. The trial also includes a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how well these treatments work in helping patients achieve remission, which means the symptoms of EGPA are reduced or disappear. Participants in the study will receive either Benralizumab, Mepolizumab, or a placebo, along with their usual care. The study will last for about 52 weeks, with an additional open-label extension period where all participants may receive Benralizumab. During the study, participants will have regular check-ups to monitor their health and the effects of the treatment.

In addition to Benralizumab and Mepolizumab, the study involves other medications such as Prednisolone, Prednisone, and Methylprednisolone, which are types of glucocorticoids, a class of drugs that help reduce inflammation. The study aims to see how these treatments can help manage EGPA symptoms and improve the quality of life for patients. Participants will be closely monitored for any side effects or changes in their condition throughout the trial.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either benralizumab or mepolizumab. These are medications used to treat eosinophilic granulomatosis with polyangiitis (EGPA).

The study is designed to last for 52 weeks, with an additional open-label extension period.

2 medication administration

The patient will receive benralizumab as a subcutaneous injection. The dosage is 30 mg, administered through a pre-filled syringe.

Alternatively, the patient may receive mepolizumab as a subcutaneous injection. The specific dosage and frequency will be determined by the study protocol.

3 oral medication

The patient will continue taking a stable dose of oral prednisolone or prednisone. The dose should be at least 7.5 mg per day but not exceed 50 mg per day.

If the patient is on methylprednisolone, it will also be administered orally.

4 monitoring and assessments

Throughout the study, the patient’s health will be monitored through various assessments, including blood tests and questionnaires about asthma symptoms and quality of life.

The study aims to evaluate the effectiveness and safety of the medications by checking the patient’s remission status at weeks 36 and 48.

5 open-label extension

After the initial 52-week period, the patient may enter an open-label extension phase where they will continue to receive the study medication.

During this phase, the focus will be on long-term safety and effectiveness, as well as monitoring any side effects.

Who Can Join the Study?

  • Participants must be male or female and 18 years or older.
  • Must have a diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA), which includes a history of asthma and high levels of a type of white blood cell called eosinophils. Additionally, they must have at least two of the following:
    • Biopsy showing certain types of inflammation.
    • Nerve problems.
    • Temporary lung issues.
    • Sinus problems.
    • Heart muscle disease.
    • Kidney inflammation.
    • Bleeding in the lungs.
    • Visible skin rash.
    • Positive test for specific antibodies (ANCA).
  • Must have a history of relapsing (at least one confirmed relapse in the last two years) or refractory (not achieving remission with standard treatment) EGPA.
  • Must be on a stable dose of the medication prednisolone or prednisone (at least 7.5 mg/day but not more than 50 mg/day) for at least four weeks before joining the study.
  • If taking other immune system-affecting medications (except cyclophosphamide), the dose must be stable for four weeks before joining the study and during the study.
  • Must have a heart test result called QTc(F) that is less than 450 milliseconds, or less than 480 milliseconds if there is a specific heart condition called bundle branch block.
  • Females who can have children must use an acceptable method of birth control from the start of the study until at least 12 weeks after the last dose of the study medication.

Who Cannot Join the Study?

  • Patients who have a different condition than Eosinophilic Granulomatosis with Polyangiitis (EGPA) cannot participate. EGPA is a rare disease that causes inflammation of blood vessels.
  • Patients who are not receiving the usual treatment for EGPA, known as Standard of Care Therapy, are excluded. This means they must be on the typical treatment plan for EGPA.
  • Patients who are not experiencing a relapsing or refractory form of EGPA are excluded. Relapsing means the disease comes back after getting better, and refractory means it does not respond to treatment.
  • Patients who are not in the age range specified for the study cannot participate. The study includes certain age groups only.
  • Both male and female patients are eligible, but those who do not fit the gender criteria are excluded.
  • Patients who are part of a vulnerable population may be excluded. This refers to groups who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Hospital Foch Suresnes France
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
medius KLINIKEN gGmbH Kirchheim Unter Teck Germany
Ksmviv Fwho Rbjzyajcgrdwd Uzv Kuqjkjvxj Iqnwxevzupq Luebeck Germany
Cwrjid Humtypocfys Uzlmjtmxkstnr Da Dfqsp Dijon France
Accpnsqbhd Porbaxbq Haunlgrh Dq Madabuksq Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
29.10.2019
France France
Not recruiting
29.10.2019
Germany Germany
Not recruiting
29.10.2019
Italy Italy
Not recruiting
29.10.2019

Trial locations

Investigated drugs:

Benralizumab is a medication used in this study to treat patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA). It works by targeting and reducing the number of eosinophils, which are a type of white blood cell involved in causing inflammation and tissue damage in EGPA. The goal of using benralizumab in this trial is to evaluate its effectiveness in maintaining remission in patients with relapsing or refractory EGPA.

Mepolizumab is another medication being compared in this study. It is also used to treat EGPA by reducing the number of eosinophils in the body. Mepolizumab helps to control the symptoms of EGPA and prevent flare-ups. The study aims to compare the effectiveness and safety of mepolizumab with benralizumab in maintaining remission in patients with EGPA.

Investigated diseases:

Eosinophilic Granulomatosis with Polyangiitis – This is a rare disease characterized by inflammation of small to medium-sized blood vessels, which can affect various organs. It often begins with symptoms like asthma and allergic rhinitis, followed by the development of eosinophilia, where there is an increased number of eosinophils, a type of white blood cell. As the disease progresses, it can lead to vasculitis, causing damage to organs such as the lungs, skin, heart, and nerves. Patients may experience symptoms like fatigue, weight loss, muscle and joint pain, and skin rashes. The disease can have periods of remission and relapse, with symptoms varying in severity.

Trial ID:
2023-510248-19-00
Protocol code:
D3253C00001
NCT ID:
NCT04157348
Trial Phase:
Therapeutic confirmatory (Phase III)

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