RecruitingPHASE3INTERVENTIONAL

Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

This 52-week study is investigating a new medication called depemokimab for adults living with Hypereosinophilic Syndrome (HES) that isn't well controlled by their current treatment. Participants will be randomly assigned to receive either depemokimab or a dummy drug (placebo), in addition to their usual care. The research team is looking for people with a confirmed HES diagnosis, who have experienced at least two HES flare-ups in the past year, and have high levels of eosinophils (a type of white blood cell) in their blood. The main goals are to find out if depemokimab can help manage HES symptoms and reduce flare-ups, and to understand its potential side effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

GlaxoSmithKline

Enrolment target

123

Start

06 Sep 2022

Estimated completion

19 Dec 2028

Hypereosinophilic Syndrome

What is this study about?

This research study is looking into a new medication called depemokimab for people who have Hypereosinophilic Syndrome (HES). HES is a condition where a specific type of white blood cell, called eosinophils, are too high in your blood and tissues, which can lead to various health problems and symptoms known as 'flares'. Even with current treatments, some people still experience these problems.

The study aims to find out if depemokimab can help control HES better and reduce the number of flares compared to a placebo (a dummy drug). A placebo is used in studies like this to make sure any improvements seen are truly due to the new medication and not just other factors. Participants will continue to receive their usual HES treatment alongside either depemokimab or the placebo.

By carefully comparing the group receiving depemokimab with the group receiving the placebo, the researchers hope to understand if depemokimab is both effective in managing HES and safe for patients. This information is crucial for developing new and better ways to treat this condition.

Key takeaways

Tests a new drug (depemokimab) for uncontrolled HES.
Compares depemokimab to a dummy drug (placebo) for 52 weeks.
Participants continue their usual HES treatment.
Aims to check effectiveness and safety of the new drug.
Requires regular clinic visits and health checks.
You won't know if you're getting the drug or placebo.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older and weigh at least 40 kilograms (around 6 stone 4 pounds). You need to have a confirmed diagnosis of Hypereosinophilic Syndrome (HES) and have been on a steady HES treatment plan for at least four weeks before starting the study. It's important that your HES is currently 'uncontrolled', meaning you've had at least two HES flare-ups in the last 12 months, and current blood tests show a high level of eosinophils.

There are also some reasons why you might not be able to join. These include having certain other health conditions like active infections, known immune system problems (other than what's caused by HES treatment), a history of lymphoma, active cancer (or cancer in remission for less than 5 years, excluding certain skin cancers), or severe heart or liver problems. The research team will carefully review your medical history to make sure the study is a safe and appropriate option for you.

If you are a woman of childbearing potential, you would need to be using highly effective contraception during the study. If you are pregnant or breastfeeding, unfortunately, you wouldn't be able to participate.

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 or older?
Do you weigh at least 40 kg (about 6 stone 4 lbs)?
Do you have a confirmed diagnosis of Hypereosinophilic Syndrome (HES)?
Have you had at least two HES flare-ups in the last year?
Are your current HES treatments not fully controlling your condition (high eosinophil count)?
Are you able to attend regular clinic appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part, this study will last for 52 weeks (approximately one year). You'll be randomly assigned, by chance, to one of two groups: two out of three participants will receive depemokimab, and one out of three will receive a placebo, which looks identical but contains no active drug. You won't know which one you're receiving, and neither will your study doctor, to ensure the results are unbiased. You will continue to take your usual HES medication throughout the study.

During the study, you will have regular visits to the clinic for assessments. These visits will include checks of your general health, blood tests (to measure eosinophil levels and other markers), and discussions about your HES symptoms and any flare-ups you might experience. The research team will also monitor for any side effects. All these assessments help the researchers understand how the treatment is working and make sure you are safe.

Potential risks and benefits

While we cannot promise any direct benefit to you from taking part, the information gained from this study could help future patients with HES. It's possible you might experience an improvement in your HES symptoms or a reduction in flare-ups if you receive the active drug. However, like all medications, depemokimab may have side effects, which will be carefully monitored. The study also involves regular clinic visits and blood tests, which might be inconvenient. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (91)

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

GSK Investigational Site
Verified postcode
San Diego, United States· Recruiting
GSK Investigational Site
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Atlanta, United States· Recruiting
GSK Investigational Site
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Boston, United States· Recruiting
GSK Investigational Site
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Southfield, United States· Withdrawn
GSK Investigational Site
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Rochester, United States· Withdrawn
GSK Investigational Site
Verified postcode
Manhasset, United States· Completed
GSK Investigational Site
Verified postcode
Cincinnati, United States· Recruiting
GSK Investigational Site
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Columbus, United States· Recruiting
GSK Investigational Site
Verified postcode
Charleston, United States· Recruiting
GSK Investigational Site
Verified postcode
Nashville, United States· Completed
GSK Investigational Site
Verified postcode
Salt Lake City, United States· Recruiting
GSK Investigational Site
Verified postcode
Buenos Aires, Argentina· Recruiting

Common questions

What is Hypereosinophilic Syndrome (HES)?

HES is a rare condition where your body produces too many eosinophils, a type of white blood cell, which can cause damage to various organs and lead to flare-ups of symptoms.

What is a placebo?

A placebo is an inactive substance or treatment that looks the same as the real drug but contains no active ingredients. It's used to compare against the new drug to see if any effects are truly due to the medicine itself.

Will I know if I'm getting the active drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving depemokimab or the placebo. This helps ensure fair and accurate results.

What does a 'flare' mean in HES?

An HES flare refers to a worsening of your symptoms or blood eosinophil counts that requires your medical team to increase your treatment.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.