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Study on Eblasakimab for Adults with Moderate-to-Severe Atopic Dermatitis Previously Treated with Dupilumab

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What is this trial about?

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

This clinical trial is focused on studying Atopic Dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The trial will evaluate a new treatment called Eblasakimab, which is a sterile solution given through an injection under the skin. The study will compare the effects of Eblasakimab to a placebo, which looks the same but does not contain the active ingredient.

The purpose of the study is to assess how effective and safe Eblasakimab is for people with moderate-to-severe atopic dermatitis who have previously been treated with another medication called Dupilumab. Participants in the study will receive either Eblasakimab or the placebo over a period of 16 weeks. During this time, they will have regular visits to the clinic to monitor their condition and any changes in their symptoms.

The study aims to see if Eblasakimab can improve the symptoms of atopic dermatitis, such as reducing the extent of skin affected and the severity of itching. The trial will also look at the overall impact on participants' quality of life and any side effects that may occur. This research is important for finding new ways to help people manage atopic dermatitis more effectively.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be randomly assigned to receive either the medication eblasakimab or a placebo. The placebo is a solution that looks identical to eblasakimab but does not contain the active ingredient.
Step 2
Medication administration
The medication or placebo will be administered through a subcutaneous injection. This means the solution is injected under the skin.
Step 3
Treatment duration
The treatment will last for a total of 16 weeks. During this period, participants will receive regular injections as part of the study protocol.
Step 4
Monitoring and assessments
Throughout the study, participants will attend clinic visits for monitoring and assessments. These visits will include evaluations of the skin condition and overall health.
The primary goal is to measure the percentage change in the Eczema Area and Severity Index (EASI) score from the start of the study to week 16.
Step 5
Secondary assessments
Secondary assessments will include various measures such as the proportion of participants achieving a clear or almost clear skin condition, reduction in EASI scores, and changes in other health-related quality of life scores.
These assessments will help determine the effectiveness and safety of the treatment.
Step 6
Completion of the study
At the end of the 16-week period, participants will undergo a final evaluation to assess the outcomes of the treatment.
The study is expected to conclude by February 28, 2025.

Who can join the trial?

10 criteria

Participants must be male or female and at least 18 years old.
Participants should be willing and able to attend clinic visits and follow study-related procedures.
Participants must have had chronic Atopic Dermatitis (AD) for at least 1 year before the screening visit. Atopic Dermatitis is a skin condition that causes itchy and inflamed skin.
Participants need to have a vIGA score of 3 or higher at the start of the study. The vIGA score is a way to measure the severity of the skin condition on a scale from 0 to 4.
Participants should have at least 10% of their body surface area affected by AD at the start of the study. Body Surface Area (BSA) is a way to measure how much of the body is affected.
Participants must have an EASI score of 18 or higher at both the screening and start of the study. The EASI score is a tool used to measure the extent and severity of eczema.
Participants should have a history of not responding well to, not tolerating, or being unable to use a stable treatment of topical corticosteroids or topical calcineurin inhibitors for AD. These are types of medications applied to the skin to reduce inflammation and treat AD.
All participants must have been previously treated with dupilumab, meeting one of the following conditions:
- Participants who stopped dupilumab because it did not work well enough, worked only partially, or stopped working must have used it for at least 16 weeks.
- Participants who stopped dupilumab due to intolerance or side effects can join the study without a required length of prior treatment.
- Participants who stopped dupilumab due to cost, loss of access, or other reasons can join the study without a required length of prior treatment.

Who cannot join the trial?

4 criteria

Participants who have not been previously treated with **dupilumab**. Dupilumab is a medication used to treat certain skin conditions.
Participants with medical conditions other than **Atopic Dermatitis**. Atopic Dermatitis is a type of skin condition that causes itchy and inflamed skin.
Participants who are not within the specified age range for the study.
Participants who are part of a vulnerable population that the study is not designed to include.

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Verified sites

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Royalderm Agnieszka Nawrocka
Warsaw, Poland

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Investigated drugs

Eblasakimab
is a medication being studied for its effectiveness in treating moderate-to-severe atopic dermatitis, a type of eczema. It is being tested in patients who have previously been treated with another medication called dupilumab. The goal of the trial is to see how well eblasakimab works in improving the symptoms of atopic dermatitis and to ensure it is safe for use in these patients.
Dupilumab
is a medication that has been used to treat moderate-to-severe atopic dermatitis. It works by targeting specific pathways in the immune system to reduce inflammation and improve skin symptoms. In this trial, patients who have already been treated with dupilumab are being evaluated to see if eblasakimab can provide additional benefits.

What is already known about the treatment

Eblasakimab – Eblasakimab is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe atopic dermatitis, especially in patients who have previously been treated with another medication called dupilumab. The medication works by targeting specific proteins in the immune system that are involved in inflammation, helping to reduce symptoms of the skin condition. Eblasakimab is classified as a monoclonal antibody, which is a type of drug designed to interact with specific molecules in the body.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The disease progresses through cycles of flare-ups and remissions, where symptoms can worsen and then improve. Commonly affected areas include the face, neck, and the insides of elbows and knees. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. The condition can significantly impact the quality of life due to persistent itching and discomfort.