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Study on Long-Term Safety and Efficacy of Amlitelimab for Patients with Moderate to Severe Atopic Dermatitis from Previous Trials

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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 long-term safety and effectiveness of a treatment called amlitelimab for people with atopic dermatitis, which is a type of eczema that causes itchy and inflamed skin. The study is designed for participants who have already taken part in previous trials involving amlitelimab for moderate to severe atopic dermatitis. Amlitelimab is administered as a solution for injection under the skin, known as a subcutaneous injection. The purpose of this study is to gather more information about how safe and tolerable amlitelimab is when used over a longer period.

Participants in this study will continue to receive amlitelimab and will be monitored for any side effects or changes in their condition. The study will also compare amlitelimab with other treatments, including agents for dermatitis that do not contain steroids, glucocorticoids, and plain corticosteroids. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the effects of amlitelimab more clearly. The study will track the percentage of participants who experience any adverse events, which are unwanted effects that occur during treatment.

The trial will last for several years, allowing researchers to observe the long-term impact of amlitelimab on atopic dermatitis. Participants will have regular visits to assess their skin condition and overall health. The study aims to provide valuable insights into how amlitelimab can help manage atopic dermatitis over time, potentially improving the quality of life for those affected by this chronic skin condition.

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

    Enrollment

    Upon joining the study, the participant will be enrolled in a long-term extension study. This study is designed to evaluate the long-term safety, tolerability, and effectiveness of a medication called amlitelimab for individuals with moderate to severe atopic dermatitis.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes verifying that the participant has previously participated in an amlitelimab clinical trial and has completed the necessary assessments during the treatment period of that trial.

  3. Step 3

    Treatment administration

    Participants will receive amlitelimab through a subcutaneous injection. The dosage, frequency, and duration of administration will be determined based on the participant's previous trial experience and the study protocol.

  4. Step 4

    Regular follow-up visits

    Participants will attend regular follow-up visits to monitor their response to the treatment. During these visits, various assessments will be conducted to evaluate the safety and effectiveness of the treatment.

  5. Step 5

    Monitoring for adverse events

    Throughout the study, participants will be monitored for any treatment-emergent adverse events (TEAEs). These are any unwanted effects that occur after starting the treatment. Participants are encouraged to report any new symptoms or changes in their condition.

  6. Step 6

    Completion of study

    Upon completion of the study, participants will undergo a final assessment. This will include a review of their overall health and any changes in their atopic dermatitis condition.

Who can join the trial?

6 criteria

  • Participant must be at least 12 years old at the time of signing the consent form.
  • Participant must have taken part in a previous clinical trial for moderate to severe atopic dermatitis (a type of skin condition) and received the study treatment. They must have completed the necessary assessments during the treatment period.
  • Participant must have reached the specific time point to join this study at the last visit of their previous study.
  • Participant must provide signed informed consent and be able to follow the study requirements.
  • Participant must have followed the previous clinical trial rules to the satisfaction of the study doctor.
  • Participant's body weight must be at least 25 kg (about 55 pounds).

Who cannot join the trial?

10 criteria

  • Participants with any other skin conditions that might interfere with the study.
  • Participants who have had a severe allergic reaction to any medication in the past.
  • Participants who are currently taking part in another clinical trial.
  • Participants who have a history of certain immune system disorders.
  • Participants who are pregnant or breastfeeding.
  • Participants with a history of drug or alcohol abuse.
  • Participants with any serious medical conditions that are not well controlled.
  • Participants who have received certain treatments for dermatitis within a specific time frame before the study.
  • Participants who have been vaccinated with a live vaccine within a certain period before the study.
  • Participants who have had a major surgery recently.
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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 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 works in managing the symptoms of atopic dermatitis. Participants in this study have already taken part in previous trials with amlitelimab, and this study aims to continue monitoring its effects over a longer period.

What is already known about the treatment

Amlitelimab – Amlitelimab is administered through an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating moderate to severe atopic dermatitis, a chronic skin condition characterized by inflammation and itching. Amlitelimab works by targeting specific proteins in the immune system to reduce inflammation and alleviate symptoms of dermatitis. It 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 itchy, red, and swollen skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become dry, cracked, and prone to infections due to scratching. Over time, repeated scratching can lead to thickened skin and changes in skin texture. The condition is associated with a malfunction in the skin barrier and an overactive immune response. Environmental factors, allergens, and stress can exacerbate symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-506548-18-00Protocol codeLTS17367Estimated enrolment1 663 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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