Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

This research trial is looking at two medicines, benralizumab and mepolizumab, to treat a condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA). EGPA is a rare illness that causes inflammation in different parts of the body. The goal is to compare how well these two medicines work and how safe they are for people who experience flare-ups or whose EGPA hasn't improved much with current treatments, including steroids. Participants will be randomly assigned to receive either benralizumab or mepolizumab, or a placebo (a dummy treatment) alongside one of the active drugs, for about a year. After this, those who complete the initial phase might be able to continue receiving benralizumab in an extended study period. This study aims to help doctors find better ways to manage EGPA.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

140

Start

29 Oct 2019

Estimated completion

30 Nov 2026

Eosinophilic Granulomatous Vasculitis

What is this study about?

This clinical trial is designed to investigate a condition called Eosinophilic Granulomatosis with Polyangiitis, or EGPA for short. EGPA is a rare condition that causes inflammation in various parts of the body, often affecting the lungs, skin, nerves, and heart. It can cause symptoms like asthma and high levels of certain white blood cells called eosinophils. For many people, EGPA can be hard to control, with symptoms returning even after treatment, or not responding well to existing medicines.

Scientists are comparing two main treatments, benralizumab and mepolizumab, to see which one is more effective and safer for managing EGPA. Both of these medicines work by targeting specific parts of the immune system that cause inflammation. The key aim is to find out if either of these drugs can reduce flare-ups, improve symptoms, and potentially allow patients to reduce their reliance on steroid medications, which can have side effects when used for a long time.

Participants in this study will receive either benralizumab or mepolizumab, administered as an injection under the skin. Some people might also receive a placebo (an inactive substance designed to look like the study drug) alongside one of the active treatments. This helps researchers fairly compare how well each medicine works. The trial will last for about a year, and if successful, could provide new and better treatment options for people living with EGPA.

Key takeaways

Compares two new injectable medicines for EGPA: benralizumab and mepolizumab.
Aims to find out which treatment is safer and more effective for EGPA.
Designed for people whose EGPA keeps coming back or isn't well controlled.
Involves regular clinic visits and medication given by injection under the skin.
The main study period is one year, with a potential option to continue longer.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

To join this study, you must be 18 years old or older. You need to have a confirmed diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA). Your EGPA must have relapsed, meaning you’ve had at least one flare-up in the past two years, or it must be difficult to control even with current treatments. You'll also need to be taking a stable dose of steroid medication (like prednisolone) every day.

There are also some specific medical requirements related to your EGPA diagnosis, such as having asthma and high levels of eosinophils, along with other signs of the condition such as nerve problems, lung issues, or certain blood test results. If you are taking other medicines to suppress your immune system, their doses need to be stable before and during the study.

You would not be able to join if you have other specific types of inflammatory conditions that are similar to EGPA, or if your EGPA has recently caused life-threatening problems. If you are a woman who could become pregnant, you would need to use effective birth control during the study and for a period after the last dose of medication.

Quick self-check

Are you 18 years old or older?
Do you have a clear diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA)?
Has your EGPA had a flare-up in the last two years, or is it hard to control with current treatments?
Are you currently taking a stable daily dose of steroid medication (like prednisolone)?
If you are a woman who could get pregnant, are you willing to use effective birth control during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. If eligible, you would be randomly assigned to one of the treatment groups: either benralizumab or mepolizumab, or sometimes a placebo (a dummy injection) alongside one of the active treatments. The medicines are given as an injection under the skin.

The main part of the study lasts for about a year (52 weeks). During this time, you would have regular visits to the clinic for check-ups, assessments, blood tests, and to receive your study medication. These visits will help doctors monitor your EGPA, how you are responding to the treatment, and if you experience any side effects. After this year, if you complete the initial treatment period, you might have the option to continue receiving open-label benralizumab (meaning you would know you are getting the active drug) for an extended period, potentially for at least another year.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new and potentially effective treatment for your EGPA that you might not otherwise have access to, and contributing to medical knowledge that could help others with EGPA in the future. However, there are also potential risks, including side effects from the study medications (which would be explained in detail), or that the treatment might not work for you. You will be closely monitored throughout the study for any health changes. Remember, participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (50)

Research Site
Denver, United States
Research Site
Ann Arbor, United States
Research Site
Rochester, United States
Research Site
Albuquerque, United States
Research Site
Great Neck, United States
Research Site
New York, United States
Research Site
Philadelphia, United States
Research Site
Denison, United States
Research Site
Seattle, United States
Research Site
Brussels, Belgium
Research Site
Brussels, Belgium
Research Site
Calgary, Canada

+38 more sites — see the official record for the full list.

Common questions

What is EGPA?

EGPA is a rare condition that causes inflammation in several parts of the body, often affecting the lungs, skin, nerves, and heart.

What kind of treatments are being tested?

The study is comparing two injectable medicines, benralizumab and mepolizumab, which work by targeting specific parts of the immune system.

Will I know which treatment I'm getting?

For the first year of the study, it's 'double-blind,' meaning neither you nor your doctor will know if you're getting benralizumab, mepolizumab, or a placebo.

How long does the study last?

The main treatment period is about 52 weeks (one year). After that, some participants might continue in an extended study with benralizumab.

Do I have to stop my current EGPA medication?

No, you must continue taking a stable dose of your steroid medication. If you're on other immune-suppressing drugs, those doses also need to be stable.