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Study of Lebrikizumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis to Understand How the Medicine Works

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What is this trial about?

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

This study focuses on moderate-to-severe atopic dermatitis, a chronic skin condition that causes itchy, inflamed skin. The research examines how a medication called lebrikizumab, given as an injection under the skin, works in treating this condition. The medication is administered through a pre-filled syringe containing 250 mg of the active substance.

The purpose of this research is to understand how lebrikizumab affects the skin at a molecular level and how these changes relate to improvements in skin condition over time. The study will look at how the medication works both during treatment and after treatment is stopped. The total duration of treatment for each participant is 60 weeks.

During the study, participants will receive injections of the medication and undergo skin examinations. Small samples of skin tissue will be taken to study the effects of the treatment. The study will also measure water loss from the skin to assess improvements in skin barrier function. Participants will be adults who have not previously used similar medications and have had atopic dermatitis for at least one year.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive Ebglyss (lebrikizumab) through subcutaneous injection (injection under the skin).
The medication comes in pre-filled syringes containing 250 mg of the solution.
This phase focuses on treating your moderate-to-severe atopic dermatitis (a skin condition causing itching and inflammation).
Step 2
Skin assessments and measurements
Your skin condition will be evaluated at specific times: weeks 2, 24, 36, and 60.
Small skin samples (biopsies) will be taken to analyze how the medication affects your skin at a molecular level.
The medical team will measure water loss through your skin to assess improvement in skin barrier function.
Step 3
Monitoring phase
Your progress will be tracked using several measurements:
The EASI score (a tool that measures the extent and severity of atopic dermatitis)
The IGA score (doctor's assessment of the severity of your condition)
The Pruritus NRS (a scale measuring the intensity of itching)
Step 4
Treatment continuation or withdrawal
At week 36, you may either continue treatment or enter a withdrawal phase.
If in the withdrawal group, the medication will be discontinued to study how your skin responds without treatment.
The study will continue monitoring your skin's condition until week 60, regardless of which group you are in.
Step 5
Final evaluation
The study concludes at week 60 with final skin assessments and measurements.
The total duration of your participation will be approximately 15 months.
All results will be analyzed to understand how the medication affects your skin condition over time.

Who can join the trial?

11 criteria

Must be at least 18 years old at screening visit
Must have been diagnosed with atopic dermatitis (a chronic inflammatory skin condition) for at least 1 year before screening, with previous topical treatments being inadequate
Must have moderate-to-severe atopic dermatitis affecting more than 10% of body surface area
Must have a moderate to severe disease score (IGA score of 3 or higher) at screening and baseline visits
Must have an EASI score of 16 or higher (EASI measures the extent and severity of atopic dermatitis)
Must have significant itching with a score of 4 or higher on the pruritus scale
Must never have received biological therapy before (must be biologic naïve)
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Women who can become pregnant must either:
- Commit to complete abstinence during the study and for 17 weeks after the last injection, or
- Use effective contraception during the study and for 17 weeks after the last injection
- Must be willing and able to follow all study requirements and attend scheduled visits
- Must understand and sign an informed consent form before any study procedures begin

Who cannot join the trial?

14 criteria

History of severe allergic reactions or anaphylaxis (life-threatening allergic reactions)
Active skin infections that could interfere with evaluating atopic dermatitis
Use of other biologic medications (specialized drugs that target specific parts of the immune system) within the past 4 months
Current participation in other clinical trials
Presence of other significant skin conditions that could impact the study assessments
Serious or unstable medical conditions
History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
Pregnant or breastfeeding women
Active or chronic infections including tuberculosis (TB), hepatitis B, or hepatitis C
Major surgery planned during the study period
Significant liver or kidney problems
History of substance abuse within the past year
Mental health conditions that could interfere with study participation
Live vaccines received within 4 weeks before starting the study

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Verified sites

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Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany

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Investigated drugs

Lebrikizumab is a medication designed to treat moderate to severe atopic dermatitis (eczema). It works by targeting a specific protein in the body called IL-13, which is involved in causing inflammation in the skin. This medication helps reduce skin inflammation, itching, and other symptoms associated with atopic dermatitis. It's administered through injections under the skin and is being studied for its long-term effects on improving skin condition and maintaining those improvements over time.

Lebrikizumab

What is already known about the treatment

Lebrikizumab - A monoclonal antibody medication administered through subcutaneous injection, specifically developed for treating moderate-to-severe atopic dermatitis (chronic inflammatory skin condition). This biological agent works by targeting and inhibiting interleukin-13 (IL-13), a key protein involved in inflammatory processes that contribute to skin inflammation and barrier dysfunction. Currently in Phase IV clinical trials, lebrikizumab belongs to the class of targeted immunomodulators and has shown promising results in managing persistent skin inflammation and improving symptoms in patients with atopic dermatitis who haven't responded adequately to conventional treatments.

Investigated diseases

Atopic Dermatitis – A chronic inflammatory skin condition that causes itchy, red, swollen, and cracked skin. The condition typically begins in early childhood but can occur at any age. It involves an overactive immune system response that leads to skin barrier dysfunction, making the skin more sensitive and prone to dryness and infections. The condition often follows a pattern of flare-ups and remissions, with symptoms varying in intensity over time. People with moderate-to-severe atopic dermatitis experience more intense symptoms affecting larger areas of the body, which can significantly impact daily activities. The condition is often associated with other allergic conditions like asthma and hay fever.