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Study on Amlitelimab for Patients Aged 12 and Older with Moderate-to-Severe Atopic Dermatitis

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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 the effectiveness and safety of a treatment for atopic dermatitis, a skin condition that causes red, itchy, and inflamed skin. 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 administered as a subcutaneous injection, meaning it is injected under the skin. Amlitelimab is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body that may contribute to inflammation. 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 and to assess its safety. Participants will receive the treatment over a period of 24 weeks. During this time, they will have regular check-ups to monitor their skin condition and overall health. The study aims to see if amlitelimab can help clear the skin or significantly reduce the severity of the symptoms compared to those who receive a placebo.

In addition to amlitelimab, the study will also involve the use of other topical treatments like tacrolimus and pimecrolimus, which are applied directly to the skin. These treatments are commonly used to manage atopic dermatitis by reducing inflammation and itching. The study will help determine the best approach to treating moderate-to-severe atopic dermatitis and provide valuable information on the potential benefits of amlitelimab for patients with this condition.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of atopic dermatitis for at least one year, and a history of inadequate response to treatments.

    Participants must be at least 12 years old and have a body weight of 25 kg or more.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of atopic dermatitis using scales like the Eczema Area and Severity Index (EASI) and the Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD).

    The involvement of at least 10% of the body surface area and a weekly average of daily itch score of 4 or higher are required.

  3. Step 3

    Treatment phase

    Participants receive either amlitelimab or a placebo through subcutaneous injections. The frequency and dosage are determined by the study protocol.

    The treatment aims to demonstrate the efficacy of amlitelimab in reducing the severity of atopic dermatitis.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment, including changes in EASI scores and vIGA-AD ratings.

    Participants are evaluated for any adverse events or side effects related to the treatment.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is performed to measure the overall effectiveness of the treatment.

    The primary goal is to achieve a significant reduction in the severity of atopic dermatitis symptoms.

Who can join the trial?

9 criteria

  • Participants must be at least 12 years old when signing the consent form.
  • Must have been diagnosed with atopic dermatitis (AD) for at least 1 year. This is a skin condition that causes itchy and inflamed skin.
  • Must have a documented history within the last 6 months of either not responding well to creams or ointments applied to the skin, or being advised not to use them. Alternatively, must have not responded well to treatments taken by mouth or injection within the last 12 months.
  • Must have a v-IGA-AD score of 3 or 4 at the start of the study. This is a way to measure the severity of the skin condition.
  • Must have an EASI score of 16 or higher at the start of the study. This is another way to measure the severity of the skin condition.
  • The skin condition must cover 10% or more of the body surface area at the start of the study.
  • Must have a weekly average of daily PP-NRS of 4 or higher at the start of the study. This is a way to measure the level of itchiness.
  • Must be able and willing to attend study visits and follow the study procedures.
  • Must weigh at least 25 kilograms.

Who cannot join the trial?

8 criteria

  • Participants who have other skin conditions that might interfere with the study.
  • Individuals who have had a recent infection that could affect the study results.
  • People who are currently using certain medications that might interfere with the study treatment.
  • Participants who have a history of severe allergic reactions.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Participants with a history of drug or alcohol abuse.
  • Individuals with certain medical conditions that the study doctors think might make it unsafe for them to participate.
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Investigated drugs

Amlitelimab is a medication being studied for its effectiveness and safety in treating moderate-to-severe atopic dermatitis, a type of eczema that causes itchy and inflamed skin. In this trial, amlitelimab is given as a monotherapy, meaning it is used alone without combining it with other treatments. The medication is administered through a subcutaneous injection, which means it is injected under the skin. The goal of the study is to see how well amlitelimab works in reducing the symptoms of atopic dermatitis in participants aged 12 years and older.

What is already known about the treatment

Amlitelimab – Amlitelimab is administered through subcutaneous injection and is currently being studied in a Phase 3 clinical trial for its effectiveness and safety in treating moderate-to-severe atopic dermatitis in individuals aged 12 years and older. This medication is still under investigation and not yet widely available in medical practice. It is primarily indicated for atopic dermatitis, a chronic skin condition characterized by inflammation and itching. Amlitelimab works by targeting specific immune pathways involved in the inflammatory process, helping to reduce symptoms associated with the condition. It falls under the pharmacological classification of monoclonal antibodies, which are designed to interact with specific proteins in the body to modulate immune responses.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The condition tends to flare periodically, with symptoms worsening and then improving. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. Environmental factors, allergens, and stress can trigger or worsen the symptoms. It is not contagious and often runs in families, suggesting a genetic component.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506557-38-00Protocol codeEFC17560Estimated enrolment820 patientsSponsorSanofi-Aventis Recherche & Developpement

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