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Study on the Effectiveness and Safety of 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 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.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current condition of atopic dermatitis.

    The assessment ensures that the condition has been present for at least one year and that there has been an inadequate response to previous treatments.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of three groups: amlitelimab treatment, tacrolimus topical treatment, or a placebo group.

    This process is double-blind, meaning neither the participants nor the researchers know which group each participant is in.

  3. Step 3

    Treatment phase

    Participants in the amlitelimab group receive a subcutaneous injection of the medication. The dosage and frequency are determined by the study protocol.

    Participants in the tacrolimus group apply the medication topically as directed.

    Those in the placebo group receive a subcutaneous injection that does not contain the active medication.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the condition and any changes in symptoms.

    Participants are assessed for improvements in skin condition, reduction in itchiness, and overall quality of life.

  5. Step 5

    Final evaluation

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

    The primary goal is to determine if there is a significant improvement in the skin condition compared to the baseline.

Who can join the trial?

9 criteria

  • Participants must be at least 12 years old.
  • Must have been diagnosed with atopic dermatitis (a type of skin condition) for at least 1 year.
  • Must have a documented history within the last 6 months of either not responding well to creams or ointments applied to the skin, or not being able 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 score measures the extent and 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 score of 4 or higher at the start of the study. This score measures the level of itchiness.
  • Must be able and willing to attend study visits and follow study procedures.
  • Must weigh at least 25 kg (about 55 pounds).

Who cannot join the trial?

7 criteria

  • Participants who have a different skin condition other than atopic dermatitis (a type of skin inflammation) that might interfere with the study.
  • Individuals who have used certain medications that could affect the study results.
  • People with a history of severe allergic reactions to any of the ingredients in the study medication.
  • Participants who have a serious health condition that could make it unsafe for them to participate.
  • Individuals who are pregnant or breastfeeding.
  • People who have participated in another clinical trial recently.
  • Participants who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Amlitelimab is a medication being studied for its effectiveness in treating moderate-to-severe atopic dermatitis, a type of eczema that causes red, 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 trial 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, commonly known as eczema. This medication is still under investigation and not yet widely available in medical practice. It is designed to help reduce inflammation and improve skin condition by targeting specific pathways involved in the immune response. Amlitelimab falls under the category of immunomodulatory agents, which are drugs that modify the immune system's activity.

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. The condition is not contagious and is often associated with other allergic conditions like asthma and hay fever.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501196-41-00Protocol codeEFC17559Estimated enrolment739 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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