Active not recruitingPHASE2INTERVENTIONAL

Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis

This research, called RACEMATE, is testing a new drug named tezepelumab for adult patients with a rare condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA). The study wants to find out if tezepelumab can help improve EGPA symptoms and how it works in the body. Participants will receive either tezepelumab or a dummy drug (placebo) for 24 weeks, alongside their usual EGPA treatments, including steroids. A main goal is to see if patients can reduce their steroid dose while their EGPA remains under control. The study will also look at whether the drug helps with asthma, nose and sinus problems, and lung function. It’s taking place in 12 hospitals across the UK.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

15 May 2024

Estimated completion

01 Sep 2026

EGPA - Eosinophilic Granulomatosis With Polyangiitis

What is this study about?

This study, known as RACEMATE, is designed to investigate a new medication called tezepelumab for adults living with a rare condition called Eosinophilic Granulomatosis with Polyangiitis, or EGPA. EGPA is a long-term illness that can cause inflammation in different parts of the body, including the lungs, skin, nerves, and heart. Currently, steroids are often used to manage EGPA, but these can have side effects when used for a long time. This research aims to understand if tezepelumab can be an effective treatment for EGPA, potentially helping patients reduce their need for steroids.

The main purpose of this study is twofold: first, to see how well tezepelumab works in treating EGPA, and second, to understand exactly how it affects the body to bring about any changes. Around 12 hospitals in the UK will be taking part. Participants will be randomly assigned to receive either tezepelumab or a placebo (a dummy drug with no active ingredients). This is a common way to test new medicines fairly, so that researchers can accurately see the drug's effects compared to no treatment. Everyone will continue their usual EGPA medications alongside the study treatment.

Over a 24-week period, the research team will carefully monitor participants. A key goal is to see if tezepelumab helps patients achieve 'remission', which essentially means their EGPA is under control and they can significantly reduce or even stop their steroid medication. The study will also track other important aspects, such as whether the drug helps reduce flare-ups of the disease, improves asthma control, lessens nose and sinus problems, and improves breathing (lung function).

Key takeaways

This study is testing a new drug for EGPA called tezepelumab.
It aims to see if the drug works and how it helps the body fight EGPA.
Participants will continue their usual EGPA treatments, including steroids.
A key goal is to help patients reduce their steroid medication safely.
The study lasts 24 weeks and involves regular check-ups.
It's taking place in 12 hospitals across the UK.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 75 years old with EGPA. Your doctor will confirm your EGPA diagnosis based on specific medical findings, such as a history of asthma, high levels of certain white blood cells (eosinophils), and other symptoms or test results that are typical of EGPA.

Additionally, you must have experienced active EGPA recently. This means you’ve either had a flare-up of your EGPA in the last two years that required an increase in your medication, or your current treatments haven't quite brought your condition fully under control. Your doctor will also check your blood test results for specific cell counts.

It's important to remember that this study is not for everyone, and the research team will check all these detailed criteria to make sure it's the right fit for you. Even if you meet some of these points, your full medical history will be reviewed to ensure your safety in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you have a confirmed diagnosis of EGPA?
Have you had EGPA flare-ups or active disease despite your current treatment within the last two years?
Are you currently receiving standard EGPA treatment, including steroids?
Can you attend regular appointments at a study hospital in the UK?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for a total of 24 weeks. During this time, you will visit one of 12 study centres across the UK. You will receive the study medication (either tezepelumab or a placebo) as an injection under the skin every four weeks. All participants will continue to take their usual EGPA medications, including steroid tablets, throughout the study.

The research team will closely monitor your EGPA. This will involve regular check-ups, blood tests, and assessments of your symptoms, such as your asthma control, and nose and sinus health. The aim is to see if your steroid dose can be gradually lowered safely during the study. There will also be evaluations of your breathing using a simple test called spirometry. You'll have regular contact with the study team who will support you throughout your participation.

Potential risks and benefits

Participating in this study might offer you the potential benefit of a new treatment (tezepelumab) that could improve your EGPA symptoms and potentially help you reduce your steroid medication, which has its own side effects. However, there's also a chance you might receive the placebo and not the active drug. As with any medication, tezepelumab could have side effects, and the research team will discuss these with you in detail. You will be closely monitored for any changes to your health. Your decision to join is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Aberdeen Royal Infirmary - NHS Grampian
Verified postcode
Aberdeen, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
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Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
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Cambridge, United Kingdom
Royal Infirmary of Edinburgh - NHS Lothian
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Edinburgh, United Kingdom
Leeds Teaching Hospitals NHS Trust
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Leeds, United Kingdom
University Hospitals of Leicester NHS Trust
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Leicester, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
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Liverpool, United Kingdom
Barts Health NHS Trust
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London, United Kingdom
Royal Free London NHS Trust
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London, United Kingdom
Guy's Hospital - Guy's and St Thomas' NHS Foundation Trust
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London, United Kingdom
Royal Brompton Hospital - Guy's and St Thomas' NHS Foundation Trust
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London, United Kingdom
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom

Common questions

What is EGPA?

EGPA (Eosinophilic Granulomatosis with Polyangiitis) is a rare auto-immune condition that causes inflammation in various body parts, often affecting the lungs, skin, nerves, and heart.

What is tezepelumab?

Tezepelumab is a new drug being tested to see if it can help treat EGPA by reducing inflammation.

What does 'placebo-controlled' mean?

It means some participants will receive the active drug, and others will receive a 'dummy' injection (placebo) that looks identical but contains no medicine. This helps researchers accurately compare the drug's effects.

How long does the study last?

If you join, the main treatment period of the study will last for 24 weeks.

Can I stop taking part if I change my mind?

Yes, you can decide to leave the study at any time without giving a reason, and it won't affect your future medical care.