Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The study will evaluate the effectiveness and safety of a treatment called amlitelimab, which is a type of protein known as a monoclonal antibody. Amlitelimab is administered through a subcutaneous injection, meaning it is injected under the skin using a pre-filled syringe. The study will compare two different dosing schedules of amlitelimab to see how well they work in maintaining the treatment response in participants aged 12 years and older who have moderate-to-severe atopic dermatitis. The study will also include a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to understand how well amlitelimab can maintain the improvement in skin condition for those who have already responded to treatment in previous studies. Participants will receive the treatment over a period of 48 weeks. During this time, the study will monitor the participants to see if they maintain their skin improvement and to check for any side effects. The study will also look at how the participants' skin condition changes over time and whether they need any additional treatments.

In addition to amlitelimab, the study will also consider other treatments like tacrolimus and pimecrolimus, which are applied topically, meaning they are applied directly to the skin. These treatments are commonly used for managing atopic dermatitis. The study aims to provide valuable information on the long-term management of atopic dermatitis and help determine the best treatment options for maintaining skin health in individuals 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, previous participation in related studies, and body weight.

    Participants must have completed a previous study related to moderate-to-severe atopic dermatitis without discontinuing the study medication.

  2. Step 2

    Treatment phase 1

    Participants receive amlitelimab as a subcutaneous injection. The dosage is administered every four weeks (Q4W).

    This phase aims to maintain the treatment response achieved in previous studies.

  3. Step 3

    Evaluation of treatment response

    The effectiveness of the treatment is evaluated by measuring the proportion of participants who maintain a clinical response at week 48.

    Various assessments are conducted to monitor skin condition and overall health.

  4. Step 4

    Treatment phase 2

    Participants continue to receive amlitelimab injections, but the frequency changes to every twelve weeks (Q12W).

    This phase further evaluates the long-term maintenance of treatment response.

  5. Step 5

    Final assessment

    At the end of the study, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

    Participants' health and any side effects experienced during the study are reviewed.

Who can join the trial?

4 criteria

  • Participants must be at least 12 years old at the time they sign the informed consent form.
  • Must have taken part in one of the three 24-week parent studies (EFC17559, EFC17560, or EFC17561) for moderate-to-severe atopic dermatitis (a skin condition that causes itchy and inflamed skin), received the study treatment without stopping it permanently, and completed the necessary assessments during the treatment period.
  • Must be able and willing to attend study visits and follow the procedures requested by the study.
  • Body weight must be at least 25 kg (about 55 pounds).

Who cannot join the trial?

10 criteria

  • Patients who have not participated in the parent studies related to this trial.
  • Patients who do not have a diagnosis of atopic dermatitis, which is a skin condition that causes itchy and inflamed skin.
  • Patients who are not within the specified age range for the trial.
  • Patients who are not considered part of the clinical trial groups specified for this study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other medical conditions that might interfere with the study or pose a risk to their health.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
  • Patients who are taking medications that could interfere with the study treatment.
  • Patients who have a history of allergic reactions to the study medication or similar treatments.
  • Patients who have participated in another clinical trial recently, which might affect the results of this study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Amlitelimab is a medication being studied for its effectiveness in treating moderate-to-severe atopic dermatitis, a type of skin condition. In this trial, it is given as a monotherapy, meaning it is used alone without other treatments. The medication is administered through an injection under the skin. The study aims to see how well amlitelimab maintains treatment response over time in participants who have already responded to it in previous studies.

What is already known about the treatment

Amlitelimab – Amlitelimab is administered as a subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe atopic dermatitis. It is in the phase 3 stage of clinical trials, indicating it is in the later stages of testing before potential approval for general medical use. The main therapeutic indication for amlitelimab is atopic dermatitis, a chronic skin condition characterized by inflammation and itching. At the molecular level, amlitelimab works by modulating the immune response, potentially reducing inflammation and symptoms associated with atopic dermatitis. It is classified pharmacologically as a monoclonal antibody, which targets specific components of the immune system to exert its effects.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become red, swollen, and cracked, and in severe cases, it can lead to thickened skin due to constant scratching. The condition is associated with a malfunction in the skin barrier and an overactive immune response. Environmental factors, allergens, and stress can trigger or worsen symptoms. It is not contagious and varies in severity among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508096-36-00Protocol codeEFC17600Estimated enrolment1 527 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.