Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 (depemokimab) compared with mepolizumab or benralizumab

This research study is for adults and teenagers with severe asthma where a certain type of white blood cell, called eosinophils, is high. This type of asthma can be difficult to manage. The study is comparing a new medication called depemokimab with two treatments already available, mepolizumab (Nucala) and benralizumab (Fasenra). The main aim is to see how well the new medicine prevents asthma attacks over 52 weeks compared to the existing ones. Researchers will also look at whether it helps improve asthma control and overall quality of life. This is a large study (Phase III) to confirm if the new drug is safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

750

Start

19 Jun 2024

Severe asthma with an eosinophilic phenotype

What is this study about?

This study is a clinical trial looking into a new medication for people who have severe asthma. Severe asthma is a type of asthma that can be very hard to control, even with usual treatments. This specific study focuses on people whose severe asthma is linked to having higher levels of certain white blood cells called eosinophils. Our bodies naturally produce eosinophils, but in some types of asthma, having too many can make your asthma worse.

The new medicine being tested is called depemokimab. The doctors and researchers want to find out if depemokimab is as good as, or 'non-inferior' to, two medicines that are already used to treat severe eosinophilic asthma: mepolizumab (known by its brand name Nucala) and benralizumab (known as Fasenra). The study will last for 52 weeks, which is about a year.

The main thing the researchers will be watching is how often people have asthma attacks that are serious enough to need extra treatment or a hospital visit. They will also be checking other important things, like how well people can control their asthma symptoms, how their breathing improves, and how their quality of life changes, using special questionnaires that measure these things. This type of study (Phase III) is a big step to confirm if a new medicine works and is safe for general use.

Key takeaways

Tests a new medicine for severe asthma called depemokimab.
Compares it to two existing asthma treatments (Nucala, Fasenra).
Focuses on people with severe asthma linked to high eosinophil levels.
Measures how well it prevents asthma attacks over 52 weeks.
Also checks for improvements in breathing, symptoms, and quality of life.
It's a year-long study and involves regular clinic visits.

Who may be eligible?

This study is looking for adults and teenagers who are 18 years old or older. Both men and women can take part.

To be eligible, you must have severe asthma that is linked to higher levels of certain white blood cells called eosinophils. Your doctor will be able to confirm if your asthma fits this description through blood tests.

There will be other detailed medical checks to make sure the study is a good fit for you and that it's safe for you to take part. This includes reviewing your medical history and other medicines you might be taking.

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 severe asthma that is difficult to control?
Has your doctor told you that your asthma is linked to high eosinophil levels?
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 in this study, you would be assigned to receive either the new medicine (depemokimab), one of the existing medicines (mepolizumab or benralizumab), or a placebo (a dummy treatment that looks like the real medicine but contains no active drug). This is decided by chance, like flipping a coin, and neither you nor your study doctor will know which treatment you are getting. This helps us ensure the results are accurate.

The medicines in this study are given as injections, either in a pre-filled syringe or similar device. You would have regular visits to the clinic over 52 weeks. At these visits, doctors and nurses would perform various health checks, conduct breathing tests, ask you about your asthma symptoms, and have you complete questionnaires about your health and quality of life. They will also look at how often you have asthma attacks during this period. The full study would last for about 52 weeks.

Potential risks and benefits

Taking part in a clinical trial might offer benefits such as access to a new treatment before it's widely available and closer monitoring of your health by medical professionals. However, there are potential risks, including side effects from the study medication, which might be new or unknown. There's also a chance you might receive a placebo and not benefit from the active treatment. You will be fully informed about any known risks before you decide to join, 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.

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Unverified
Slovenia
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Unverified
Netherlands
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Unverified
Portugal
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Unverified
Italy
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Unverified
France
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Unverified
Sweden
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Unverified
Finland
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Unverified
Norway
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Unverified
Spain
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Unverified
Germany
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Unverified
Ireland
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Unverified
Austria

Common questions

What are 'eosinophils' and why are they important for this study?

Eosinophils are a type of white blood cell. In some people with severe asthma, having high levels of eosinophils can make their asthma symptoms worse. This study focuses on treatments that target these specific cells.

What does 'double-blind' mean in a study?

Double-blind means that neither you (the participant) nor your study doctor will know which treatment you are receiving. This helps make the study results as fair and accurate as possible.

What is a 'placebo'?

A placebo is an inactive substance or treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine more accurately.

Will I still take my regular asthma medicines?

Yes, you would typically continue to take your usual asthma medicines alongside the study treatment. The study team will give you specific guidance on all your medications.

How long will I be in the study?

The main part of this study will involve active treatment and follow-up for 52 weeks, which is about one year.