AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Lebrikizumab in Adult and Adolescent Participants with Moderate-to-Severe Face and Neck Atopic Dermatitis

Atopic dermatitis, commonly known as eczema, causes dry, sore, and itchy skin. When eczema flares up on the face and neck, it can be particularly uncomfortable, visible, and distressing. This study is testing an injection called lebrikizumab (brand name Ebglyss) to see how well it works for moderate-to-severe eczema in these sensitive areas. Participants will be placed into one of two groups: one receives lebrikizumab injections, while the other receives a dummy treatment (placebo) containing no active medicine. Neither the participants nor the research team will know who receives which injection during the 16-week study period. The main goal is to find out if lebrikizumab can significantly clear the skin on the face and neck by week 16. The trial team will also look at whether the treatment relieves itching and improves general quality of life, sleep, and emotional wellbeing.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Almirall S.A.

Enrolment target

273

Start

22 Sep 2026

Face and Neck Atopic Dermatitis

What is this study about?

Atopic dermatitis (eczema) is a long-term condition that makes the skin dry, cracked, inflamed, and intensely itchy. Having eczema on your face and neck can be especially challenging because the skin there is thin, delicate, and constantly exposed. Standard steroid creams can sometimes be unsuitable for long-term use on facial areas, so doctors are looking for safer, targeted treatments.

Lebrikizumab is an advanced type of medication known as a biologic. Instead of treating just the surface of the skin, it works within the immune system to block a specific protein called IL-13. This protein plays a key role in causing the swelling, redness, and itching associated with eczema. By calming this pathway, researchers hope the medicine can help the skin heal.

This trial is a Phase 3 study, meaning lebrikizumab has already been tested in earlier studies and is now being checked in a larger group of people to confirm its effectiveness and safety. Researchers want to find out what percentage of people achieve clear or almost clear skin on their face and neck after 16 weeks of treatment.

Taking part in studies like this helps doctors discover whether newer, targeted therapies can make a meaningful difference for people whose eczema has not responded well to standard creams and treatments.

Key takeaways

Testing a targeted injection (lebrikizumab) for moderate-to-severe eczema on the face and neck.
A 16-week study comparing the active drug against a dummy injection (placebo).
Aims to achieve clear or almost clear skin and improve everyday quality of life.
Open to adults aged 18 and older whose facial eczema needs stronger treatment.
Participation is entirely voluntary and you can leave the study at any point.

Who may be eligible?

This study is designed for adults aged 18 and older who have moderate-to-severe atopic eczema specifically affecting their face and neck. Your eczema must be active enough to meet the study's severity criteria at the start of the trial.

To take part, you should be someone whose eczema has not been fully controlled by everyday skin creams, or someone who is looking for a systemic (whole-body) treatment option. Men and women can both join.

You may not be eligible if you have other skin conditions that could confuse the results, active serious skin infections, or if you are using certain strong medications that cannot be stopped during the study. A study doctor will review your full medical history to decide if the trial is safe and suitable 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.

I am aged 18 or older.
I have been diagnosed with atopic eczema.
My eczema noticeably affects my face and neck.
My skin condition is currently moderate to severe and causes daily discomfort.
Standard moisturising creams or everyday treatments are not controlling my eczema well enough.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first visit the clinic for a screening appointment. The research team will examine your skin, check your general health, and explain the study steps. If you are eligible, you will be randomly assigned by a computer to receive either lebrikizumab or a matching placebo injection.

You will receive the medicine as an injection just under the skin using a pre-filled syringe. You will have regular appointments at the hospital or clinic over a 16-week period. During these visits, the study team will examine your face and neck, take blood and urine samples, and monitor your general health.

You will also be asked to fill in simple questionnaires about your symptoms. These ask about your itch levels, how well you are sleeping, and how your skin condition is affecting your day-to-day life and mood. The trial team will support you throughout the entire 16 weeks and follow up with you afterwards.

Potential risks and benefits

Taking part may help clear your eczema symptoms, reduce itching, and give you close, regular monitoring from a team of skin specialists. However, there is no guarantee you will personally benefit, especially if you are placed in the placebo group. Like all medications, lebrikizumab can have side effects, which may include mild pain or redness where the needle goes in, headaches, or eye irritation (such as conjunctivitis). Taking part is completely voluntary, and you can withdraw from the study at any time without giving a reason and without it affecting your standard NHS care.

Locations (6)

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

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Unverified
Poland
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Unverified
Germany
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Unverified
Portugal
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Unverified
France
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Unverified
Spain
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Unverified
Denmark

Common questions

What is a placebo injection?

A placebo looks identical to the real medicine but contains no active ingredient. It is used so researchers can be sure any improvements seen are truly caused by the study drug and not by chance.

Can I choose whether I get the real drug or the placebo?

No. A computer randomly decides which group you join. Neither you nor your study doctor will know which treatment you are getting during the 16-week period.

Do I have to pay to take part in this study?

No. The study medication and all trial visits are provided free of charge. Most trials also offer help with reasonable travel expenses.

Can I still use my regular moisturisers?

Yes, basic moisturisers (emollients) are usually encouraged. However, the study team will guide you on which creams you can use and when to apply them.

What happens if my eczema gets much worse during the study?

Your safety is the top priority. If your eczema flares up severely, the study doctors can step in with rescue treatments to soothe your skin and protect your health.