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Study on the Effectiveness and Safety of Depemokimab vs. Mepolizumab for Adults with Relapsing or Refractory Eosinophilic Granulomatosis with Polyangiitis

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What is this study about?

This clinical trial is focused on studying a condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA), which is a rare disease that causes inflammation of blood vessels and can affect various organs. The study aims to compare the effectiveness and safety of two treatments: Depemokimab and Mepolizumab. Both medications are given as a solution for injection under the skin. Depemokimab is administered every 26 weeks, while Mepolizumab is given every 4 weeks. The trial will also include a placebo group for comparison.

The purpose of the study is to evaluate how well Depemokimab works compared to Mepolizumab in adults with relapsing or refractory EGPA who are already receiving standard care. Participants will be randomly assigned to receive either Depemokimab, Mepolizumab, or a placebo. The study will last for 52 weeks, during which participants will receive regular injections and attend scheduled visits to monitor their health and the effects of the treatment.

Throughout the study, participants will be closely monitored to assess the duration of remission, which means a period when the disease is not active, and to track any relapses, which are episodes when the disease symptoms return. The study will also measure the amount of oral corticosteroids, a type of medication often used to manage EGPA, that participants need during the trial. This research will help determine if Depemokimab is as effective as Mepolizumab in managing EGPA symptoms and maintaining remission.

1 randomization and baseline assessment

Upon joining the study, participants are randomly assigned to receive either depemokimab or mepolizumab. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

Baseline assessments are conducted to evaluate the participant’s current health status and to confirm eligibility criteria, including a stable dose of oral corticosteroids and any ongoing immunosuppressive therapy.

2 treatment administration

Participants receive depemokimab as a subcutaneous injection every 26 weeks or mepolizumab as a subcutaneous injection every 4 weeks. The specific medication and schedule depend on the randomization group.

The study lasts for 52 weeks, during which the participant continues to receive their assigned treatment according to the schedule.

3 ongoing assessments

Throughout the study, regular assessments are conducted to monitor the participant’s health and response to treatment. These assessments include measuring the Birmingham Vasculitis Activity Score (BVAS) and the dose of oral corticosteroids.

The primary goal is to achieve remission, defined as a BVAS of 0 and a corticosteroid dose of 4 mg/day or less at both Week 36 and Week 52.

4 end of study evaluation

At the end of the 52-week period, a final evaluation is conducted to assess the overall efficacy and safety of the treatment.

The total duration of remission and any relapses are documented, along with the mean corticosteroid dose during the last four weeks of the study.

Who Can Join the Study?

  • The participant must be a male or female who is 18 years or older.
  • The participant must weigh at least 40 kg (about 88 pounds).
  • The participant must have a documented diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) for at least 6 months. This includes having asthma and a high number of a type of white blood cell called eosinophils, along with at least two other specific features of EGPA, such as:
    • A biopsy showing certain types of inflammation.
    • Nerve problems.
    • Lung issues that are not fixed.
    • Problems with the nose or sinuses.
    • Heart problems shown by specific tests.
    • Kidney problems.
    • Lung bleeding.
    • Visible skin spots.
    • Positive test for certain antibodies.
  • The participant must have a history of relapsing or refractory disease:
    • Relapsing disease: At least one confirmed relapse of EGPA in the past 2 years, needing more medication or hospital stay, and occurring at least 12 weeks before the first screening visit.
    • Refractory disease: Not achieving remission or having symptoms return while reducing medication within the last 6 months before the first screening visit.
  • The participant must be on a stable dose of oral corticosteroid medication (between 7.5 mg and 50 mg per day) for at least 4 weeks before the second visit.
  • If the participant is receiving immunosuppressive therapy (except cyclophosphamide), the dosage must be stable for 4 weeks before the second visit and during the study.
  • If the participant is a female, she must not be pregnant or breastfeeding and must meet one of the following conditions:
    • Not able to have children.
    • Able to have children but using a highly effective birth control method from at least 14 days before the first dose of the study medication until a specified time after the last dose.
  • The participant must be able to give signed informed consent, agreeing to follow the study’s requirements and restrictions.
  • For participants in France, they must be affiliated with or a beneficiary of a social security category.

Who Cannot Join the Study?

  • Patients who have a different condition than Relapsing or refractory 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 (SoC) therapy, are excluded. SoC therapy refers to the regular treatment that is commonly accepted for a condition.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who belong to a group that is not included in the study’s target population are excluded. The study is designed for specific groups of people.
  • Patients who are part of a vulnerable population that the study does not include are excluded. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.

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
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy
Medical University Of Graz Graz Austria
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Johannes Wesling Klinikum Minden Minden Germany
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Universita’ Politecnica Delle Marche Ancona Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Ldabh Updghdnlehjh Mipyhep Civonhc (bzdye Leiden The Netherlands
Uncptcbgeead Mhrxore Cendfwo Gakwloyow Groningen The Netherlands
Nsepvwvh Igrlyqzne Oh Teedcqrrmimr Aoj Lfwe Drmlqcln Warsaw Poland
Bahschtcns Ilouzfmbnuth Bnwvi Iudzzadvnjalf Kzdurg Budapest Hungary
Ucjaanldmcdtpm Cdijnir Kbxfofxtl Gdansk Poland
Fywncvgxg Pbyk Lq Ibmkfdmbeuixt Bgbcuwcyd Dez Howxyhma Uxcmxgxplqtyz Lo Plp Madrid Spain
Hgalzdtj Unybwlzatvdcg Huikufuv Tbzal y Punrnv Igmwdndp Csshlt dhxtwiscpeggujpjq (jtti Badalona Spain
Hyydqlmr Veul decypjpn Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
14.07.2022
Belgium Belgium
Not recruiting
14.07.2022
France France
Not recruiting
14.07.2022
Germany Germany
Not recruiting
14.07.2022
Hungary Hungary
Not recruiting
14.07.2022
Italy Italy
Not recruiting
14.07.2022
Poland Poland
Not recruiting
14.07.2022
Portugal Portugal
Not recruiting
14.07.2022
Spain Spain
Not recruiting
14.07.2022
Sweden Sweden
Not recruiting
14.07.2022
The Netherlands The Netherlands
Not recruiting
14.07.2022

Trial locations

Investigated drugs:

Depemokimab is a medication being studied for its effectiveness in treating adults with a condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA). This condition is characterized by inflammation of blood vessels and can cause a variety of symptoms. Depemokimab is given as an injection under the skin every 26 weeks. The study aims to see how well it works in reducing the symptoms of EGPA compared to another medication.

Mepolizumab is another medication used in the study for treating Eosinophilic Granulomatosis with Polyangiitis (EGPA). It is also given as an injection under the skin, but more frequently, every 4 weeks. Mepolizumab is already used to help control the symptoms of EGPA by reducing inflammation in the blood vessels. The study compares its effectiveness and safety to that of depemokimab.

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 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 damage in organs such as the lungs, skin, heart, and nerves due to the inflammation of blood vessels. Symptoms may include fatigue, weight loss, muscle and joint pain, and skin rashes. The disease can have periods of remission and relapse, where symptoms improve and then worsen again.

Trial ID:
2023-510019-20-00
Protocol code:
217102
Trial Phase:
Therapeutic confirmatory (Phase III)

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