Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Expanded access program for mepolizumab in subjects with hypereosinophilic syndrome.

This study is for adults (18 years and older) who have a rare blood condition called Hypereosinophilic Syndrome, or HES. This condition means you have too many of a certain type of white blood cell, which can cause problems in your body. The study is looking at a medicine called mepolizumab to confirm if it's a safe and effective treatment for HES. This is an 'expanded access program', which means it might allow people to get a medicine that isn't widely available yet, under certain conditions. It's a Phase III trial, which means the medicine has already been studied and shown some promise, and now researchers are gathering more information about its benefits and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

30 Jul 2024

Hypereosinophilic Syndrome

What is this study about?

This clinical trial is designed for people living with a rare condition called Hypereosinophilic Syndrome (HES). In simple terms, HES is a condition where your body produces too many of a specific type of white blood cell, called eosinophils. These excess cells can travel through your bloodstream and settle in different parts of your body, potentially causing inflammation and damage to organs like your skin, heart, lungs, or digestive system. This can lead to a variety of symptoms, which can sometimes be serious.

The study is focusing on a medicine called mepolizumab. This medication aims to reduce the number of these problematic white blood cells. Researchers want to gather more information to confirm how safe and effective mepolizumab is for individuals with HES. This is an important step in potentially making mepolizumab a more widely available treatment option for those who need it.

This specific study is an 'expanded access program.' This often means that if you have a serious condition and there are no other suitable treatments, you might be able to access a promising medicine that is still being studied but isn't yet fully approved or available everywhere. It's a structured way to provide potential treatment while continuing to gather vital information about its use. The information collected from participants, such as any effects of the medication (both good and bad), will help doctors understand more about how best to use mepolizumab for HES.

Key takeaways

Study is for adults with Hypereosinophilic Syndrome (HES).
Investigating a medicine called mepolizumab.
Aims to confirm safety and effectiveness.
This is an expanded access program.
Participation involves regular checks and monitoring.
You can stop participating at any time.

Who may be eligible?

This study is for adults aged 18 years and older. Both men and women can take part in this research.

To be considered for this study, you must have been diagnosed with Hypereosinophilic Syndrome (HES). Other specific health conditions might also be checked to make sure this study is the right fit for you.

It's important to remember that joining a clinical trial is a significant decision. Your doctors will carefully review your medical history and current health to determine if you meet all the necessary criteria to ensure your safety and that the study can gather accurate information.

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?
Have you been diagnosed with Hypereosinophilic Syndrome (HES)?
Are you able to attend regular appointments for monitoring?
Are you willing to potentially receive study medication, mepolizumab?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would receive the study medication, mepolizumab, as prescribed. The study team will closely monitor your health throughout your involvement. This would involve regular check-ups, which include assessments by your doctor and possibly blood tests. These checks are to monitor how you are responding to the medication, track any effects you experience, and ensure your safety.

The study will specifically look at things like any serious unwanted effects, any non-serious unwanted effects that your doctor thinks might be related to mepolizumab, and the dose of the medication you receive over a certain period. The overall length of your participation would be discussed in detail with the study team, but it involves ongoing treatment and monitoring.

Potential risks and benefits

Taking part in a study like this might offer the possibility of receiving a new treatment for Hypereosinophilic Syndrome that isn't widely available yet, which could potentially improve your condition. However, as with any medication, there are potential risks and side effects that you might experience. These could range from mild to serious, and the study team will discuss all known potential side effects with you in detail. It's also important to remember that joining the study is voluntary, and you are free to withdraw 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
Poland

Common questions

What is Hypereosinophilic Syndrome (HES)?

HES is a rare condition where your body has too many of a specific type of white blood cell (eosinophils), which can cause problems in your organs.

What is mepolizumab?

Mepolizumab is a medicine being studied to see if it can help reduce the high number of eosinophils in people with HES.

Could I get this medicine if I'm not in the study?

Because this is an expanded access program, it might allow access to the medicine for people with HES who meet specific criteria and have no other treatment options, but it's not generally available outside of specific study settings yet.

What does 'Phase III' mean?

Phase III means the medicine has already shown promise, and researchers are now collecting more information on its safety and effectiveness on a larger scale.

Will I have to pay to be in the study?

Generally, clinical trials cover the costs of study medication and study-related visits. Your healthcare team can provide specific details for this trial.