This clinical trial is focused on studying atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study will evaluate the effectiveness and safety of a treatment called amlitelimab, which is a type of protein known as a monoclonal antibody. Amlitelimab is administered through a subcutaneous injection, meaning it is injected under the skin using a pre-filled syringe. The study will compare two different dosing schedules of amlitelimab to see how well they work in maintaining the treatment response in participants aged 12 years and older who have moderate-to-severe atopic dermatitis. The study will also include a comparison with a placebo, which is a substance with no active medication.
The purpose of the study is to understand how well amlitelimab can maintain the improvement in skin condition for those who have already responded to treatment in previous studies. Participants will receive the treatment over a period of 48 weeks. During this time, the study will monitor the participants to see if they maintain their skin improvement and to check for any side effects. The study will also look at how the participants’ skin condition changes over time and whether they need any additional treatments.
In addition to amlitelimab, the study will also consider other treatments like tacrolimus and pimecrolimus, which are applied topically, meaning they are applied directly to the skin. These treatments are commonly used for managing atopic dermatitis. The study aims to provide valuable information on the long-term management of atopic dermatitis and help determine the best treatment options for maintaining skin health in individuals with this condition.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, previous participation in related studies, and body weight.
Participants must have completed a previous study related to moderate-to-severe atopic dermatitis without discontinuing the study medication.
2treatment phase 1
Participants receive amlitelimab as a subcutaneous injection. The dosage is administered every four weeks (Q4W).
This phase aims to maintain the treatment response achieved in previous studies.
3evaluation of treatment response
The effectiveness of the treatment is evaluated by measuring the proportion of participants who maintain a clinical response at week 48.
Various assessments are conducted to monitor skin condition and overall health.
4treatment phase 2
Participants continue to receive amlitelimab injections, but the frequency changes to every twelve weeks (Q12W).
This phase further evaluates the long-term maintenance of treatment response.
5final assessment
At the end of the study, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.
Participants’ health and any side effects experienced during the study are reviewed.
Who Can Join the Study?
Participants must be at least 12 years old at the time they sign the informed consent form.
Must have taken part in one of the three 24-week parent studies (EFC17559, EFC17560, or EFC17561) for moderate-to-severe atopic dermatitis (a skin condition that causes itchy and inflamed skin), received the study treatment without stopping it permanently, and completed the necessary assessments during the treatment period.
Must be able and willing to attend study visits and follow the procedures requested by the study.
Body weight must be at least 25 kg (about 55 pounds).
Who Cannot Join the Study?
Patients who have not participated in the parent studies related to this trial.
Patients who do not have a diagnosis of atopic dermatitis, which is a skin condition that causes itchy and inflamed skin.
Patients who are not within the specified age range for the trial.
Patients who are not considered part of the clinical trial groups specified for this study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other medical conditions that might interfere with the study or pose a risk to their health.
Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
Patients who are taking medications that could interfere with the study treatment.
Patients who have a history of allergic reactions to the study medication or similar treatments.
Patients who have participated in another clinical trial recently, which might affect the results of this study.
Amlitelimab is a medication being studied for its effectiveness in treating moderate-to-severe atopic dermatitis, a type of skin condition. In this trial, it is given as a monotherapy, meaning it is used alone without other treatments. The medication is administered through an injection under the skin. The study aims to see how well amlitelimab maintains treatment response over time in participants who have already responded to it in previous studies.
Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. The condition is associated with a malfunction in the skin barrier and an overactive immune response. Environmental factors, allergens, and stress can trigger or worsen symptoms. It is not contagious and varies in severity among individuals.
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