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Study on Amlitelimab for Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis Using Topical Corticosteroids and Inadequate Response to Previous Treatments

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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 effects of a medication called amlitelimab in people aged 12 years and older who have moderate to severe atopic dermatitis, commonly known as eczema. Atopic dermatitis is a skin condition that causes red, itchy, and inflamed skin. The study is designed for participants who have not responded well to previous treatments, such as biologic therapies or oral medications known as Janus Kinase (JAK) inhibitors. Participants will continue using their usual topical treatments, like corticosteroids, which are creams or ointments applied to the skin to reduce inflammation.

The purpose of the study is to evaluate how effective and safe amlitelimab is when given as a subcutaneous injection, which means it is injected under the skin. The study will compare the effects of amlitelimab to a placebo, which is a substance with no active medication. Participants will be randomly assigned to receive either amlitelimab or the placebo. The study will last for a period of 36 weeks, during which participants will receive regular injections and attend scheduled visits to monitor their progress and any changes in their condition.

Throughout the study, researchers will assess various aspects of the participants' skin condition, including the severity of eczema symptoms and the overall impact on their quality of life. The study aims to provide valuable information on whether amlitelimab can offer a new treatment option for those with moderate to severe atopic dermatitis who have not found relief with other therapies. Participants will be closely monitored for any side effects or adverse reactions to ensure their safety during the trial.

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 (AD) for at least one year, and previous inadequate response to certain 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 assessment includes measuring the percentage of body surface area affected by AD and the intensity of symptoms such as itching.

  3. Step 3

    Treatment phase

    Participants receive subcutaneous injections of amlitelimab or a placebo. The injections are administered using a pre-filled syringe.

    The treatment is given alongside background topical corticosteroids, which are applied to the skin as part of the standard care for AD.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the participant's response to the treatment. These visits include assessments of skin condition, symptom severity, and any side effects.

    The primary goal is to observe improvements in the skin condition and overall quality of life over a 36-week period.

  5. Step 5

    End of study evaluation

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

    The evaluation focuses on achieving clear or almost clear skin and a significant reduction in symptoms compared to the baseline measurements.

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 of not responding well to a previous biologic medication for atopic dermatitis or an oral JAK inhibitor (a type of medication).
  • 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 (BSA) 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 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?

9 criteria

  • Participants who have a history of severe allergic reactions to any of the ingredients in the study medication.
  • Individuals with other skin conditions that might interfere with the study results.
  • Patients who have used certain medications recently that could affect the study outcomes.
  • People with certain infections that are not well controlled.
  • Participants who are pregnant or breastfeeding.
  • Individuals with a history of certain types of cancer.
  • Patients with significant health issues that could make participation unsafe.
  • Anyone who has participated in another clinical trial recently.
  • Individuals who are unable to comply with the study procedures.
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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. It is given by injection under the skin. The trial aims to see how well it works for people who have not had enough improvement with other treatments, such as biologic therapies or oral medications known as Janus Kinase (JAK) inhibitors.

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 and older. This medication is particularly aimed at patients who have not responded adequately to previous biologic therapies or oral Janus Kinase (JAK) inhibitors. Amlitelimab works by targeting specific pathways in the immune system to reduce inflammation and alleviate symptoms of dermatitis. It is classified as a biologic agent, focusing on modulating immune responses to improve skin conditions.

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 and can persist into adulthood, though the severity and symptoms can vary over time. The skin may appear red, swollen, and cracked, and it can become thickened from repeated scratching. Flare-ups can occur due to various triggers, including allergens, stress, and changes in weather. The condition is often associated with other allergic disorders such as asthma and hay fever. Managing atopic dermatitis involves identifying and avoiding triggers, as well as maintaining skin hydration.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508099-12-00Protocol codeEFC17599 - AQUAEstimated enrolment852 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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