Not recruiting

Study on Reducing Dupilumab Dose for Patients with Controlled Atopic Eczema

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The clinical trial is focused on studying atopic eczema, a common skin condition that causes the skin to become itchy, red, and inflamed. The treatment being tested in this study is called Dupixent, which is a solution for injection containing the active substance dupilumab. Dupilumab is already used to treat atopic eczema, but this study aims to explore if the frequency of its administration can be reduced while still effectively managing the condition.

The purpose of the study is to evaluate and compare the effectiveness of administering Dupixent every 2 weeks, every 3 weeks, and every 4 weeks over a period of 16 weeks. Participants in the study will receive Dupixent injections at one of these intervals. The study will monitor the condition of the participants' skin and assess any changes in the severity of their eczema. This will help determine if less frequent dosing is as effective as the current standard dosing schedule.

Throughout the study, participants will be asked to report on their eczema symptoms and overall quality of life. The study will also track any side effects or adverse reactions to the treatment. By the end of the study, researchers hope to gather valuable information that could lead to more convenient treatment options for people with atopic eczema.

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
Joining the trial
Upon joining the trial, you will have already signed an informed consent form. This indicates your willingness to participate and comply with the study requirements.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are an adult with a diagnosis of atopic eczema and that your condition is controlled according to specific criteria.
Step 3
Medication administration
You will continue to receive dupilumab, a medication administered as a subcutaneous injection. Initially, you have been receiving 300 mg every 2 weeks.
During the trial, the frequency of your dupilumab injections may be adjusted to every 2 weeks, every 3 weeks, or every 4 weeks. This adjustment will be determined randomly.
Step 4
Monitoring and assessments
Throughout the trial, your condition will be monitored regularly. This includes assessments at week 16 and week 24 to evaluate the severity of your eczema using various scales and questionnaires.
You will be asked to complete self-reported assessments regarding your eczema severity and quality of life.
Step 5
End of trial
The trial is expected to conclude by August 31, 2024. At the end of the trial, a final assessment will be conducted to evaluate the outcomes of the different dosing schedules.

Who can join the trial?

5 criteria

The person is an adult.
The person has a diagnosis of atopic eczema.
The person receives dupilumab 300 mg every 2 weeks for the treatment of atopic eczema.
The person has controlled disease according to the Treat-to-Target criteria. This means their condition is being managed well with treatment.
The person has voluntarily signed and dated an informed consent before any study-related procedure. This means they agree to participate in the study and understand what it involves. If they cannot sign themselves, a legal representative can do it for them.

Who cannot join the trial?

9 criteria

Patients with a history of severe allergic reactions to the study medication.
Patients who are currently participating in another clinical trial.
Patients with other skin conditions that might interfere with the study results.
Patients who have used certain medications that could affect the study within a specific time frame before the trial.
Patients with a history of certain chronic diseases that are not well controlled.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who have received a live vaccine within a certain period before the trial.
Patients with any condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Verified
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

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Investigated drugs

Dupilumab is a medication used in this clinical trial to help manage atopic eczema, which is a skin condition that causes itchy and inflamed skin. It works by blocking certain proteins in the body that can cause inflammation, helping to reduce the symptoms of eczema. In this trial, the researchers are testing different schedules for taking dupilumab to see if less frequent dosing is as effective as the standard dosing schedule. This could potentially make the treatment more convenient for patients while still keeping their eczema under control.

Dupilumab

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection under the skin, typically every two weeks, but this trial is exploring less frequent dosing. It is currently well-established in medical literature as a treatment for atopic eczema, a condition that causes itchy and inflamed skin. Dupilumab works by blocking certain proteins in the body that contribute to inflammation, helping to reduce symptoms of eczema. It is classified as a monoclonal antibody, a type of medication that targets specific parts of the immune system.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis, also known as atopic eczema, is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. The skin may become thickened and cracked over time due to persistent scratching and inflammation. Environmental factors, allergens, and stress can trigger or exacerbate symptoms. The condition is associated with a malfunction in the skin barrier and an overactive immune response.