Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A multi-centre, single arm, open-label extension study to evaluate the long-term safety of GSK3511294 (Depemokimab) in adult and adolescent participants with severe asthma with an eosinophilic phenotype from studies 206713 or 213744

This research is an 'open-label extension study', meaning everyone involved knows they are receiving the study medicine. It focuses on the long-term safety of a medicine called GSK3511294 (also known as Depemokimab) for people aged 18 and over, including teenagers, who have a specific type of severe asthma (called eosinophilic asthma). Participants in this study will have already taken part in previous studies of this medicine (studies 206713 or 213744). Over 52 weeks (about one year), we will carefully monitor any side effects and check if the body develops a reaction to the medicine. We will also look at how often asthma flare-ups happen, and how the medicine affects their asthma control and quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

372

Start

14 Feb 2024

Severe asthma with an eosinophilic phenotype

What is this study about?

This study is particularly important because it's looking at the long-term effects of a new medicine, GSK3511294 (Depemokimab), for a specific type of severe asthma. Severe asthma can be very difficult to manage, and treatments that target the 'eosinophilic' type of asthma aim to reduce the specific immune cells (eosinophils) that drive inflammation in the airways in some people. By extending earlier studies, researchers can gather more information about how safe the medicine is over a longer period.

The main goal of this study is to closely monitor any side effects that might occur over one year. This helps researchers understand the full safety profile of the medicine. They will also be checking for something called 'immunogenicity', which means whether the body develops antibodies against the medicine. If the body develops these antibodies, it might affect how well the medicine works in the long run.

Beyond safety, the study also aims to see how the medicine helps with asthma control. Researchers will look at how often participants have severe asthma attacks (exacerbations), how well they can breathe (measured by FEV1), and how their quality of life improves. This long-term picture is vital for understanding the full benefits and any potential challenges of this new treatment for severe asthma.

Key takeaways

This study is for adults and teenagers with severe eosinophilic asthma.
It's an extension for people who have been in earlier studies with the same medicine.
The main focus is to check the long-term safety of the medicine over one year.
Researchers will also track asthma flare-ups and how well asthma is controlled.
All participants will know they are receiving the study medicine.

Who may be eligible?

To be able to join this study, everyone must have already taken part in one of two specific earlier studies involving the same medicine (either study 206713 or study 213744).

Participants must be 18 years old or older, including adults and some teenagers. The study is open to both men and women.

Because this study is an extension, the main criteria for joining are based on having completed one of those previous studies and meeting certain health requirements to safely continue receiving the study medicine.

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.

Have you taken part in GSK studies 206713 or 213744 previously?
Are you 18 years old or older?
Do you have a diagnosis of severe eosinophilic asthma?
Are you able to attend regular study appointments for about one year?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to receive the study medicine, GSK3511294, as part of the research. You will have regular appointments at the study centre over a period of 52 weeks (approximately one year). During these visits, the study team will carry out various assessments. These will include checking for any side effects you might experience, taking blood and urine samples, performing breathing tests, and asking questions about your asthma symptoms and how you are feeling. You will also be asked to complete questionnaires about your asthma control and quality of life. The study team will provide all necessary care and monitor your health closely throughout your participation. You can withdraw from the study at any time.

Potential risks and benefits

The potential benefit of taking part is that you would continue to receive a new medicine that may help manage your severe asthma. As with all medicines, there is a risk of side effects, some of which may be serious. The study team will monitor you closely for any adverse events. You are free to withdraw from the study at any time and for any reason, which will not affect your usual medical care.

Locations (7)

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

—
Unverified
Germany
—
Unverified
Spain
—
Unverified
Poland
—
Unverified
Hungary
—
Unverified
Czechia
—
Unverified
France
—
Unverified
Italy

Common questions

What is an 'eosinophilic phenotype' of asthma?

This is a specific type of severe asthma where certain immune cells called eosinophils are more active, causing inflammation in your airways.

What does 'extended study' mean?

It means this study is a continuation for people who have already taken part in a previous research study with the same medicine.

What does 'open-label' mean?

It means that both you and the study doctors will know you are receiving the study medicine, rather than a dummy treatment (placebo).

What are 'immunogenicity' checks?

These check if your body develops antibodies against the study medicine, which could affect how well it works.

How long will I be in the study?

Participation in this study will last for 52 weeks, which is about one year.

How to find out more

Official trial record

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