Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

E-merge - Evaluation of MEpolizumab-based regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study

The E-merge study is looking for a better way to treat a rare condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA), which used to be known as Churg-Strauss syndrome. This condition causes inflammation in different parts of the body. The study will compare a new treatment approach that includes a drug called mepolizumab (also known as Nucala) against the usual treatments. The main goal is to find out if this new approach can help people with EGPA take less of a steroid medication called prednisone, without their symptoms getting worse (a 'relapse'). It's hoped this could improve their quality of life by reducing steroid side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

100

Start

04 Oct 2024

Eosinophilic granulomatosis with polyangiitis (EGPA)formerly called Churg-Strauss syndrome

What is this study about?

The E-merge study is a research project designed to find the most effective way to treat a rare illness called Eosinophilic Granulomatosis with Polyangiitis (EGPA), which was previously known as Churg-Strauss syndrome. EGPA is a long-term condition that causes inflammation in various organs, including the lungs, skin, heart, and nerves. Many people with EGPA need to take steroid medications like prednisone for a long time, which can have side effects.

This study aims to discover if a treatment plan involving a drug called mepolizumab (brand name Nucala) is better at helping patients reduce their daily dose of prednisone to a low level (4 mg or less) without their EGPA flaring up again. Mepolizumab is a drug that helps reduce certain types of white blood cells called eosinophils, which are often too high in people with EGPA.

The study will compare this mepolizumab-based treatment with the standard treatments currently used for EGPA. By doing this, researchers hope to improve how EGPA is managed, helping patients feel better and potentially lowering the risks associated with long-term steroid use. This is a "Phase III" study, which means it's one of the final steps before a new treatment might become widely available.

Key takeaways

This study tests a new treatment idea for EGPA to reduce reliance on steroids.
It compares mepolizumab-based treatment with standard care.
The main goal is to help patients lower their prednisone dose without relapse.
Participation involves regular clinic visits and close health monitoring.
This is a 'Phase III' study, a crucial step before a new treatment can be widely approved.

Who may be eligible?

This study is looking for adults aged 18 years and older who have been diagnosed with Eosinophilic Granulomatosis with Polyangiitis (EGPA).

Both men and women can take part in this research. The most important thing is that you have a confirmed diagnosis of EGPA. Your study doctor will check other medical details to make sure this study is right and safe for you.

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 18 years old or older?
Do you have a confirmed diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA)?
Are you able to attend regular clinic appointments?
Are you comfortable with the concept of being assigned a treatment by chance (randomly)?
Have you discussed your current medications with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two treatment groups – either the group receiving the mepolizumab-based treatment or the group receiving standard treatment. This is done by chance, like flipping a coin, and neither you nor your doctor will know which group you are in (this is called 'double-blind').

Throughout the study, you would have regular visits to the clinic where doctors and nurses would monitor your health and examine you. You'd likely provide blood samples for tests, and your medication doses would be carefully adjusted. The study would last for over a year (364 days), with key assessments at 168 days and at the end. Your doctor will explain all the visits, tests, and medicines in detail.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new treatments before they are widely available and close monitoring of your health by a specialist team. However, there are also potential risks, including side effects from the study medications, which will be fully explained to you. There's also no guarantee that the new treatment will be more effective than your current one. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is EGPA?

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

What is prednisone?

Prednisone is a type of steroid medication often used to reduce inflammation. While effective, long-term use can have side effects.

What is mepolizumab (Nucala)?

Mepolizumab is a drug that aims to reduce inflammation by targeting specific white blood cells called eosinophils, which are often overactive in people with EGPA.

Why is this study 'double-blind'?

Double-blind means neither you nor your doctors will know which treatment you are receiving. This helps make the study results more reliable and fair.

How long will the study last?

The main part of the study will last about a year (364 days) with regular check-ups and monitoring during that time.