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Study on the Effectiveness and Safety of Amlitelimab for Patients Aged 12 and Older with Moderate-to-Severe Atopic Dermatitis Using Topical Corticosteroids

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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 new treatment for atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The treatment being tested is called amlitelimab, which is given as an injection under the skin. Amlitelimab is a type of protein known as a monoclonal antibody, which is designed to target specific parts of the immune system that may be involved in causing atopic dermatitis. The study will also involve the use of a placebo, which is a substance with no active medication, to compare the effects of amlitelimab.

The purpose of this study is to evaluate how effective and safe amlitelimab is for people aged 12 and older who have moderate-to-severe atopic dermatitis. Participants will continue using their regular topical treatments, such as corticosteroids, during the study. The trial will last for about 24 weeks, during which participants will receive injections of either amlitelimab or a placebo. The study will monitor changes in the severity of the skin condition and any side effects experienced by the participants.

In addition to amlitelimab, the study will also consider the effects of other treatments like tacrolimus and pimecrolimus, which are commonly used topical medications for atopic dermatitis. These treatments are applied directly to the skin and work by reducing inflammation and suppressing the immune response. The study aims to provide more information on how amlitelimab compares to these existing treatments in managing atopic dermatitis symptoms.

The research process

The trial runs in 6 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, participants will be assessed to ensure they meet the eligibility criteria. This includes being at least 12 years old, having a diagnosis of atopic dermatitis for at least one year, and a documented history of inadequate response to previous treatments.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to evaluate the severity of their atopic dermatitis. This includes measuring the Eczema Area and Severity Index (EASI) score and the percentage of Body Surface Area (BSA) affected.

  3. Step 3

    Randomization

    Participants will be randomly assigned to one of three groups: receiving amlitelimab by subcutaneous injection, receiving a placebo, or continuing with background topical corticosteroids.

  4. Step 4

    Treatment phase

    Participants in the amlitelimab group will receive the medication through subcutaneous injection. The exact dosage and frequency will be determined by the study protocol.

    Participants in the placebo group will receive injections that do not contain the active medication.

    All participants will continue using background topical corticosteroids as part of their treatment regimen.

  5. Step 5

    Follow-up assessments

    Throughout the study, participants will have regular follow-up assessments to monitor the effectiveness and safety of the treatment. This includes evaluating changes in the EASI score, the vIGA-AD scale, and other health indicators.

  6. Step 6

    End of study evaluation

    At the end of the study, participants will undergo a final evaluation to assess the overall impact of the treatment on their atopic dermatitis. This will include a comprehensive review of all collected data and any changes in symptoms.

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 topical treatments (creams or ointments applied to the skin) within the last 6 months, or not responding well to systemic therapies (medications that work throughout the body) 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** (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 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?

10 criteria

  • Participants who have a history of severe allergic reactions to any of the study medications.
  • Individuals with other skin conditions that might interfere with the study, such as psoriasis or severe acne.
  • People who have used certain medications that could affect the study results, like oral steroids, within a specific time before the study starts.
  • Participants with a history of certain infections, such as tuberculosis, that could be worsened by the study medication.
  • Individuals who have received any other investigational drug within a certain period before the study.
  • Pregnant or breastfeeding women, as the study medication might affect the baby.
  • Participants with a history of certain immune system disorders that could affect the study results.
  • Individuals who have been vaccinated with live vaccines within a specific time before the study.
  • People with a history of alcohol or drug abuse that might interfere with their ability to follow the study procedures.
  • Participants who have any other medical condition that the study doctors believe could make it unsafe for them to participate.
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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 skin condition. It is administered through a subcutaneous injection, which means it is injected under the skin. The trial aims to see how well amlitelimab works in improving the symptoms of atopic dermatitis when used alongside standard topical treatments.

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 primarily indicated for individuals aged 12 years and older who are already using topical corticosteroids for their condition. Amlitelimab works by targeting specific pathways in the immune system to reduce inflammation and alleviate symptoms of dermatitis. 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 disease progresses through periods of flare-ups, where symptoms worsen, and remissions, where symptoms improve or disappear. 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 exacerbate symptoms. The condition is not contagious and is often associated with other allergic conditions like asthma and hay fever.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506558-20-00Protocol codeEFC17561Estimated enrolment914 patientsSponsorSanofi-Aventis Recherche & Developpement

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