This clinical trial is focused on studying the effectiveness and safety of a new treatment for atopic dermatitis, a condition also known as eczema, which causes the skin to become red, itchy, and inflamed. The study involves participants aged 12 years and older who have moderate-to-severe forms of this condition. The treatment being tested is called amlitelimab, which is a type of protein known as a monoclonal antibody. It is designed to be administered through a subcutaneous injection, meaning it is injected under the skin using a pre-filled syringe. The study will compare the effects of amlitelimab to a placebo to determine its effectiveness.
The purpose of the study is to evaluate how well amlitelimab works in reducing the symptoms of atopic dermatitis compared to a placebo. Participants will receive the treatment over a period of 24 weeks. During this time, they will be monitored to see if there is an improvement in their skin condition, specifically looking for a reduction in redness, itching, and the overall severity of the eczema. The study will also assess the safety of amlitelimab by observing any side effects that may occur during the treatment period.
In addition to amlitelimab, the study will also consider the use of other treatments like tacrolimus and pimecrolimus, which are topical medications applied directly to the skin. These treatments are commonly used for managing eczema symptoms. The study aims to provide valuable information on whether amlitelimab can be a more effective treatment option for those suffering from moderate-to-severe atopic dermatitis. Participants will be closely followed by healthcare professionals throughout the study to ensure their safety and to gather comprehensive data on the treatment’s impact.



France
Germany
Greece
Poland