Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC injection in adult participants with Moderate to Severe Atopic Dermatitis

This research study is looking at a new treatment called GSK1070806 for adults who have moderate to severe eczema, also known as atopic dermatitis. Eczema can make your skin very itchy, dry, and inflamed, which can be hard to live with. In this study, we're trying to find out how effective this new medicine is at improving eczema symptoms, how safe it is, and what the best amount (dose) to give patients might be. Participants will be randomly given either the new medicine or a 'dummy' medicine (placebo) by an injection under the skin. We'll be closely watching how their eczema changes over 16 weeks to understand if the new treatment helps.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

04 Mar 2024

Dermatitis Atopic

What is this study about?

Imagine you have eczema, and it's making your skin really uncomfortable. Scientists are always trying to find better ways to help people with conditions like this. This study is testing a new medicine called GSK1070806, which might help adults whose eczema is quite bad – what doctors call moderate to severe atopic dermatitis. Atopic dermatitis is a long-term condition that causes your skin to become red, itchy, dry, and sometimes cracked.

The main goal of this research is to see if this new medicine can make eczema symptoms better. We're also checking how safe it is and if there are any side effects. Another important part of the study is to work out the best amount (dose) of the medicine to give. This helps make sure that if the medicine works, we know how to use it safely and effectively in the future.

To make sure the results are fair and accurate, some people in the study will get the new medicine by injection under their skin, while others will get a 'dummy' injection that looks the same but contains no active medicine (this is called a placebo). Neither you nor your doctor will know which one you’re getting until the study is over. This helps us compare the new medicine directly to not having the active medicine, so we can be sure any improvements are due to the medicine itself.

Key takeaways

This study is for adults with moderate to severe eczema.
It tests a new medicine called GSK1070806 given by injection.
We're looking at how well it works, if it's safe, and the best dose.
Some participants will get a dummy medicine (placebo).
The main improvement will be measured after 16 weeks.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over. There's no upper age limit, meaning older adults are welcome to take part too.

Both men and women can join this study. The researchers want to include a wide range of people to make sure the results apply to many different individuals with eczema.

The most important thing is that you have been diagnosed with moderate to severe atopic dermatitis, which is a common type of eczema that can be quite troublesome for those who have it.

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 moderate to severe atopic dermatitis (eczema)?
Are you able to attend regular clinic visits?
Are you willing to receive injections under your skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in this study for a certain amount of time. You'll have regular visits to the clinic where the doctors and nurses will check on your health and your eczema. These visits will involve various tests and assessments, such as looking at your skin, asking you questions about how you feel, and taking blood samples.

You will receive either the new study medicine, GSK1070806, or a dummy medicine. This will be given as an injection under your skin. You or your doctor won't know which one you're getting until after the study is finished. The main part of the study where we look at how your eczema changes will last for 16 weeks, which is about four months. After this, there might be follow-up periods to see how you're doing long-term.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment before it's widely available, and close monitoring of your health by medical professionals. However, there are also potential risks, like side effects from the medicine, or the inconvenience of regular clinic visits. You might also receive the dummy medicine, meaning your eczema may not improve from the study treatment. It is very important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Czechia
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Unverified
Germany
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Unverified
France
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Unverified
Italy
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Unverified
Greece
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Unverified
Poland
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Unverified
Spain
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Unverified
Bulgaria

Common questions

What is atopic dermatitis?

Atopic dermatitis is a common type of eczema that makes your skin itchy, red, dry, and sometimes inflamed. It's often a long-term condition.

What is a 'Phase 2b' study?

This means it's a medium-stage study. We've checked the medicine is safe in a small group, and now we're looking to see how well it works and find the best dose in a larger group.

What does 'double-blind' mean?

It means neither you nor your study doctor will know if you're getting the new medicine or the dummy medicine. This helps make the study results fair.

What does an 'SC injection' mean?

SC stands for 'subcutaneous', which means the medicine will be given as an injection just under your skin, similar to an insulin jab.

What is 'brief summary: Percent Change From Baseline in the Eczema Area and Severity Index (EASI) to Week 16'?

This means the main way we'll measure if the medicine works is by looking at how much your eczema (its area and severity) improves after 16 weeks compared to how it was at the start.