Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Long-Term Safety and Effectiveness of Amlitelimab for Adults with Moderate to Severe Atopic Dermatitis

Verified siteRegistered drugNo placebo
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 the long-term effects of a treatment for atopic dermatitis, a condition commonly known as eczema, which causes the skin to become itchy, red, and inflamed. The treatment being tested is called amlitelimab, which is given as an injection under the skin. The study aims to understand how safe and tolerable this treatment is for adults who have moderate to severe forms of atopic dermatitis.

Participants in the study will receive the amlitelimab treatment over a period of time, and researchers will monitor them to see how their condition responds. The study will also include a comparison with a group receiving a placebo, which is a substance with no active medication. This helps researchers determine the true effects of the treatment. The study will track any side effects or changes in the participants' skin condition, as well as their overall health and quality of life.

The goal of this research is to gather information on the safety and effectiveness of amlitelimab for treating atopic dermatitis. By participating, individuals contribute to a better understanding of how this treatment can help manage the symptoms of eczema and improve the lives of those affected by 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 visit

    Upon joining the study, you will attend an initial visit. During this visit, your medical history will be reviewed to confirm eligibility. This includes checking if you have had atopic dermatitis for at least one year and if you have tried other treatments without success.

    You will undergo a physical examination, and your skin condition will be assessed using specific scales to measure the severity of your dermatitis.

  2. Step 2

    Treatment administration

    You will receive the medication amlitelimab as a solution for injection. This will be administered under the skin, known as a subcutaneous injection.

    The frequency and dosage of the medication will be determined by the study protocol, and you will be informed about the schedule for receiving these injections.

  3. Step 3

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your response to the treatment. These visits will include assessments of your skin condition and any side effects you may experience.

    During these visits, you will be asked to report any changes in your symptoms and overall health.

  4. Step 4

    Safety and efficacy assessments

    Throughout the study, the safety of the treatment will be closely monitored. This includes checking for any adverse events or side effects that may occur.

    The effectiveness of the treatment will also be evaluated by measuring changes in your skin condition and quality of life.

  5. Step 5

    End of study procedures

    At the end of the study, you will have a final visit where your overall health and skin condition will be assessed.

    You will be provided with information about the results of the study and any further steps you may need to take regarding your treatment.

Who can join the trial?

9 criteria

  • Participant must be at least 18 years old at the time of signing the informed consent.
  • Participants must have had atopic dermatitis (AD) for 1 year or longer. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
  • Participant must have a documented history within 6 months before the screening visit of either not responding well to or being advised against using topical treatments. Topical treatments are medications applied directly to the skin.
  • Participant must have an Eczema Area Severity Index (EASI) score of 16 or higher at the baseline visit. The EASI is a tool used to measure the extent and severity of eczema.
  • Participant must have a Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) score of 3 or 4 at the baseline visit. This scale is used to assess the overall severity of atopic dermatitis.
  • Participant must have atopic dermatitis affecting 10% or more of their body surface area (BSA) at the baseline visit. Body surface area refers to the percentage of the body affected by the condition.
  • Participant must have a weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) score of 4 or higher at the baseline visit. This scale measures the intensity of itching.
  • Participant must be able and willing to attend study visits and follow study procedures.
  • Participants must use contraception as per local regulations. Female participants must not be pregnant or breastfeeding.

Who cannot join the trial?

10 criteria

  • Patients with any other skin conditions that might interfere with the study.
  • Patients who have had a severe allergic reaction to any medication in the past.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of certain infections, such as tuberculosis.
  • Patients who have a weakened immune system, which means their body has a harder time fighting infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have received certain vaccines recently.
  • Patients who have a history of cancer, except for some types of skin cancer.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have any other medical condition that the study doctors think might make it unsafe for them to 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.

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 potential to help people with moderate to severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. This medication is given as an injection under the skin. The main goal of using amlitelimab in this study is to see how safe it is for long-term use and how well it can help manage the symptoms of atopic dermatitis. Participants in the trial receive this medication to see if it can improve their skin condition over time without causing significant side effects.

What is already known about the treatment

Amlitelimab – Amlitelimab is administered through a subcutaneous injection, which means it is injected under the skin. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating moderate to severe atopic dermatitis, a type of skin inflammation. The medication works by targeting specific proteins in the immune system to reduce inflammation and alleviate symptoms of dermatitis. Amlitelimab is classified as an immunomodulatory agent, which means it helps regulate the immune system's response.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin barrier is compromised, leading to increased sensitivity and susceptibility to infections. It commonly affects areas such as the face, neck, and the insides of elbows and knees. The condition is associated with other allergic disorders like asthma and hay fever. Over time, repeated scratching can lead to thickened skin and further irritation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502188-39-00Protocol codeLTS17789 / ATLANTISEstimated enrolment1 269 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.