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A Study of Lebrikizumab for Adults and Adolescents with Moderate to Severe Atopic Dermatitis to Evaluate Effects on Eczema and Skin Barrier Function

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at atopic dermatitis, a skin condition that causes areas of skin to become inflamed, itchy, red, cracked, and rough. The study will focus on people who have moderate to severe forms of this condition, meaning their symptoms are more than mild but can range to quite serious. The treatment being tested is lebrikizumab, which is also known by the code names RO5490255 and LY3650150. This medication is given as an injection under the skin using a pre-filled pen device. The purpose of the study is to confirm how well lebrikizumab works in improving the skin condition in people with moderate to severe atopic dermatitis.

During the study, participants will receive lebrikizumab treatment over a period of time, with the study lasting up to 24 weeks. The medication will be given at a dose of up to 500 milligrams per day, with a total amount of up to 3750 milligrams throughout the treatment period. The study will look at both areas of skin that show visible signs of the condition and areas that appear normal to see how the treatment affects the skin barrier, which is the protective outer layer of the skin that helps keep moisture in and harmful substances out.

The study will measure various aspects of the skin condition and how it responds to treatment. This includes looking at how much the overall severity of the skin condition improves, whether itching gets better, and how the condition affects quality of life. The study will also examine the skin in more detailed ways by measuring things like moisture levels, the natural protective substances in the skin, and other physical properties of the skin. Some measurements will involve taking samples from the skin surface using special tape, and in some adult participants, small skin samples may be taken. Blood tests will also be done to check vitamin D levels.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
Your treatment will begin with lebrikizumab, which is a medication designed to treat moderate to severe atopic dermatitis (also known as eczema).
The medication will be administered as a subcutaneous injection, which means it will be injected under your skin.
The product used is called Ebglyss 250 mg solution for injection in pre-filled pen.
This treatment phase will continue throughout your participation in the study.
Step 2
Regular monitoring visits
During the study, you will attend scheduled visits where various assessments will be performed to monitor your eczema and skin condition.
Your skin will be evaluated using different measurement methods to assess how well the treatment is working.
These assessments will include checking both areas of your skin that are affected by eczema (called lesional skin) and areas that appear normal (called non-lesional skin).
Step 3
Skin function measurements
Your skin barrier function will be measured using a technique called EIS (a method to assess how well your skin protects your body).
Some participants will have additional measurements taken, including evaporimetry (which measures water loss from your skin), Epsilon, and TiVi (other skin assessment techniques).
These measurements help evaluate how your skin barrier is functioning and whether it improves with treatment.
Step 4
Skin sample collection
Skin samples will be collected using a method called tape stripping, where adhesive tape is gently applied to your skin and removed to collect surface skin cells.
These samples will be analyzed for NMF (natural moisturizing factor, which helps keep your skin hydrated) and skin lipids (natural fats in your skin).
If you are an adult participant, you may also have a small skin sample (biopsy) taken for more detailed analysis using a technique called ToF-SIMS.
Step 5
Vitamin D assessment
If you are an adult participant, your vitamin D levels will be checked through a blood sample.
Vitamin D levels may also be assessed in your skin biopsy sample.
This information helps understand the relationship between vitamin D and your skin condition.
Step 6
Questionnaire completion
You will be asked to complete several questionnaires throughout the study to assess how your eczema affects your daily life.
These include POEM (Patient-Oriented Eczema Measure, which tracks your eczema symptoms), MADRS-S (a mood assessment), and RECAP (which evaluates how eczema impacts your life).
You will also rate your itch severity using a numerical rating scale (NRS).
Another questionnaire called DLQI (Dermatology Life Quality Index) will assess how your skin condition affects your quality of life.
Step 7
Clinical assessments
Your doctor will regularly assess your eczema using standardized scoring systems.
The EASI score (Eczema Area and Severity Index) measures the extent and severity of your eczema across different body areas.
The IGA (Investigator's Global Assessment) is another tool your doctor will use to evaluate the overall severity of your eczema.
Step 8
Week 24 final assessment
At week 24, you will have your final study visit.
During this visit, all the assessments will be repeated to measure how much your eczema has improved since the beginning of the study.
The main measure of success will be whether you have achieved at least a 75% reduction in your EASI score compared to when you started the study.
This final visit marks the completion of your participation in the study.

Who can join the trial?

4 criteria

You must provide your written agreement to take part in this clinical trial.
You must be an adult between 18 and 64 years of age, or you must be an adolescent aged 12 years or older but under 18 years and weigh at least 40 kilograms (about 88 pounds). You must be a person who could benefit from treatment that works throughout the entire body for atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin also known as eczema.
You must have been diagnosed with atopic dermatitis by a doctor, and your doctor must have determined that treatments applied directly to your skin, such as creams or ointments, have not worked well enough to control your condition.
If you are an adolescent between 12 and under 18 years of age, your parent or legal guardian must sign a written agreement allowing you to participate. If you are 15 years of age or older, you must also provide your own written agreement to take part in the trial.

Who cannot join the trial?

3 criteria

The study does not list specific exclusion criteria in the provided information, meaning detailed reasons why patients cannot participate are not available in this document.
Generally, clinical trials may exclude patients based on other health conditions, previous treatments, or laboratory test results, but these specific details are not provided here.
If you have questions about whether you can participate, you will need to discuss your individual situation with the research team conducting the trial.

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Verified sites

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Verified
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
Responsive
Region Oestergoetland
Linkoping, Sweden
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Region Skane Skanes Universitetssjukhus
Lund, Sweden

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Investigated drugs

Lebrikizumab is a medication being tested to treat moderate to severe atopic dermatitis, which is also known as eczema. This medicine works by targeting specific proteins in the body that cause inflammation and skin problems. In this study, researchers want to see how well lebrikizumab can improve eczema symptoms and help repair the skin's protective barrier in both affected areas of skin and areas that look normal.

Lebrikizumab

What is already known about the treatment

Lebrikizumab – Lebrikizumab is an injectable medication currently being studied in clinical trials for the treatment of moderate to severe atopic dermatitis, a chronic skin condition that causes itchy and inflamed patches of skin. This medication works by blocking a specific protein called interleukin-13 (IL-13), which plays a key role in causing inflammation and damage to the skin's protective barrier in people with eczema. Lebrikizumab belongs to a class of drugs called monoclonal antibodies, which are designed to target specific molecules in the body's immune system. The medication is being evaluated for its ability to improve eczema symptoms and restore the skin's natural protective function in both affected and unaffected areas of the skin in adults and adolescents.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition that causes red, itchy, and dry patches on the skin. The disease typically begins in childhood but can persist into adulthood or develop later in life. It progresses through periods of flare-ups, when symptoms worsen, and remission, when the skin improves. The affected skin becomes very dry and sensitive, often leading to intense itching that can disrupt sleep and daily activities. Over time, repeated scratching and inflammation can cause the skin to thicken and develop a leathery texture. The condition often occurs alongside other allergic diseases such as asthma or hay fever.