AuthorisedTherapeutic use (Phase IV)Interventional

A Phase IV, non-randomized, open-label multinational trial to assess the mechanism of action for Lebrikizumab in moderate-to-severe atopic dermatitis

This study is investigating Ebglyss, a new medication for people suffering from moderate to severe eczema. It's a 'Phase IV' study, meaning the medicine is already approved, and researchers are now focusing on understanding exactly how it works. They will collect small skin samples (biopsies) from participants at different times. By looking closely at the genetic material in these samples, they hope to see how Ebglyss changes the skin at a very detailed, molecular level from the beginning of treatment and over a longer period. This information will help doctors understand better how this medicine helps improve eczema symptoms.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

University Of Michigan

Enrolment target

Start

04 Aug 2025

Moderate-to-severe atopic dermatitis

What is this study about?

This study is about a medicine called Ebglyss, used for moderate to severe eczema, also known as atopic dermatitis. Eczema can make your skin itchy, red, and inflamed, and for some people, these symptoms can be quite severe and impact their daily life. Ebglyss is already approved for use, but this study, a 'Phase IV' trial, aims to understand in much greater detail how it actually works inside the body.

The main goal is to look at tiny changes that happen in your skin after you start using Ebglyss. Researchers will take very small pieces of skin, called biopsies, from the affected areas. They will then examine these samples to see how the medicine changes the genetic instructions (called transcriptomic and epigenetic profiles) within your skin cells over time. This is like looking at the 'master plan' of your skin cells to understand how Ebglyss helps them become healthier.

They will also monitor other things, like how well your skin barrier improves (meaning how well your skin keeps moisture in and irritants out), and whether these detailed changes in the skin match up with improvements you might feel, such as less itching and better-looking skin. This detailed understanding will help doctors and patients know more about the benefits of Ebglyss and how it tackles eczema at its root.

Key takeaways

This study investigates how Ebglyss works for moderate to severe eczema.
It's a Phase IV study, focusing on the medicine's detailed effects on skin cells.
Small skin samples (biopsies) will be taken to see genetic changes.
The study aims to link these cellular changes to visible skin improvement and reduced itching.
Ebglyss is given as an injection.
Adults aged 18 and over can participate.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years or older. There is no upper age limit, meaning older adults can also take part.

This study is open to both men and women. The main requirement is that you have been diagnosed with moderate to severe eczema, as it's specifically looking at how Ebglyss works for this condition.

Your study doctor will discuss all the requirements with you in detail to make sure this is the right study for you.

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 eczema (atopic dermatitis)?
Are you able to attend regular clinic visits?
Are you willing to have small skin biopsies taken?
Are you comfortable receiving medication by injection?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive Ebglyss as an injection using a pre-filled syringe. You'll have several visits to the clinic over a period of time. At these visits, doctors will monitor your eczema and take small skin biopsy samples from either affected or previously affected areas of your skin. These samples are crucial for understanding how the medicine is working at a detailed level.

Your skin barrier function will be measured regularly, and you'll be asked about your symptoms like itching. The study also looks at what happens after you stop the medicine, so there might be a period where you discontinue Ebglyss, and researchers will continue to observe your skin. The total duration of your participation, including follow-up, will be explained by your study team.

Potential risks and benefits

Taking part in a study like this could help us understand more about how Ebglyss works for eczema, potentially benefiting future patients. You'll also receive regular medical attention for your condition. However, there are potential risks, such as discomfort or bruising from the skin biopsies or injections, and possible side effects from the medication, which your doctor will explain fully. 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.

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Unverified
Germany

Common questions

What is eczema?

Eczema, or atopic dermatitis, is a common skin condition that makes your skin red, itchy, dry, and sometimes inflamed.

What is a 'Phase IV' study?

A Phase IV study means the medicine is already approved and available. These studies help doctors understand more about how the medicine works or affects patients in the long term.

What is Ebglyss?

Ebglyss is the name of the medicine being studied; it's a solution given by injection to treat moderate to severe eczema.

What will researchers do with my skin samples?

Researchers will look very closely at the samples to see how the medicine changes the instructions inside your skin cells, helping them learn how Ebglyss improves eczema.

Will I feel better during the study?

While the aim is to understand the medicine, some participants may experience an improvement in their eczema symptoms. However, this is not guaranteed for everyone, and your condition will be carefully monitored.