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AuthorisedTherapeutic use (Phase IV)Interventional

An interventional, Open-label Study to Evaluate the effect of lebrikizumab on eczema and Skin Barrier Function parameters in lesional and non-lesional skin in Adults and Adolescents with Moderate to Severe Atopic Dermatitis

This study is about a medicine called lebrikizumab (also known as Ebglyss) for adults with moderate to severe eczema, called atopic dermatitis. It's an 'open-label' study, which means everyone involved knows they are receiving the medicine. Researchers want to see how well lebrikizumab works in real-world settings, specifically if it can significantly clear up eczema patches and improve the skin's natural barrier. They will follow patients for 24 weeks to see how their skin improves and how their quality of life changes. This is a Phase IV study, meaning the medicine is already approved, and this research helps us understand its effects better in everyday use.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Region Oestergoetland
Enrolment target
30
Start
12 Feb 2026

What is this study about?

This study is investigating a medicine called lebrikizumab, also known as Ebglyss, for people in the UK who have moderate to severe atopic dermatitis – that's the common name for eczema. Eczema can be very uncomfortable, causing red, itchy, and dry skin. This study aims to understand how well Ebglyss helps improve these symptoms and if it strengthens the skin's natural barrier, which is important for keeping moisture in and irritants out. The study is 'open-label,' meaning both you and your doctors will know you are receiving Ebglyss.

This isn't an early trial of a new medicine; Ebglyss has already been approved for use. This type of study, often called a Phase IV study, helps doctors learn more about how a medicine works in real-life situations with a wider group of patients. It's about gathering more information on its effects on eczema and how it helps people's quality of life.

The main thing the researchers want to find out is how many people see a significant improvement in their eczema – specifically, at least a 75% reduction in their eczema severity after 24 weeks. They will also look at other important things like how much the itching improves, how eczema affects daily activities, and changes to the skin barrier that you can't see but are vital for healthy skin.

Key takeaways

  • This study is for adults with moderate to severe eczema.
  • It's looking at how well a medicine called Ebglyss (lebrikizumab) works in real-world use.
  • The main goal is to see if eczema symptoms improve significantly over 24 weeks.
  • Researchers will also check effects on skin barrier health and quality of life.
  • This is an 'open-label' study, meaning everyone knows they are getting the medicine.

Who may be eligible?

This study is for adults, aged 18 and older, who have moderate to severe eczema (atopic dermatitis). Both men and women can take part.

To be considered, your eczema needs to be active and causing you significant problems, which is why it's described as 'moderate to severe'. The medical team will check details about your health and eczema to make sure this study is right for you and safe.

The study is looking for patients who fit specific health requirements, which will be discussed in detail if you show interest. This ensures the study gathers consistent information and keeps all participants safe.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with moderate to severe eczema (atopic dermatitis)?
  3. Are you looking for new treatment options for your eczema?
  4. Are you able to attend regular appointments for 24 weeks?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, Ebglyss, which is given as an injection using a pre-filled pen. You would typically learn how to do this yourself or with help. The study will last for 24 weeks, though specific details on the number of visits would be provided by the study team.

During the study, doctors and nurses will regularly check your skin and eczema. This will include measuring how much your eczema has improved, how it affects your daily life, and possibly taking small skin samples (like a light 'tape strip' from the skin surface, or for some adults, a tiny skin biopsy) to look at skin health at a microscopic level. They might also check your blood, including your vitamin D levels. All these checks are to understand how the medicine is working for you.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving your moderate to severe eczema symptoms and gaining a better understanding of your condition. However, as with any medicine, there could be side effects or risks associated with taking Ebglyss, and these would be fully explained to you. You have the right to withdraw from the study 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.
  • Unverified
    Sweden

Common questions

What is atopic dermatitis?

Atopic dermatitis is the medical term for eczema, a common skin condition that causes patches of skin to become itchy, red, dry, and cracked.

What is Ebglyss?

Ebglyss (also known as lebrikizumab) is a medicine that has been approved for treating moderate to severe eczema.

What does 'open-label' mean?

It means that both you and your study doctors will know you are receiving the active study medicine, Ebglyss. There's no placebo involved.

How long will the study last?

The study will follow participants for 24 weeks, which is about six months.

Will I get free treatment?

During the study, you will receive the study medicine, Ebglyss. The study team can provide more details about this.

How to find out more

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

Discussion

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