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Study on Tralokinumab and Topical Corticosteroids for Children and Infants with Moderate-to-Severe Atopic Dermatitis

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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 atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The trial will evaluate the effectiveness and safety of a medication called tralokinumab, which is used in combination with topical corticosteroids. Topical corticosteroids are creams or ointments applied to the skin to reduce inflammation and itching. The study will involve children aged 2 to under 12 years and infants aged 6 months to under 2 years who have moderate-to-severe atopic dermatitis.

The purpose of the study is to determine if tralokinumab combined with topical corticosteroids provides better control of the skin symptoms of atopic dermatitis compared to a placebo combined with topical corticosteroids. The trial will also explore how this treatment affects symptoms like itching and the overall impact on the quality of life for both the children and their caregivers. Additionally, the study will look into how the treatment influences skin colonization by a common bacteria called Staphylococcus aureus and the composition of lipids in the outer layer of the skin, which is an indirect measure of skin barrier function.

Participants in the study will receive either the active treatment or a placebo, which is a substance with no active medication, for a period of up to 150 days. The trial is designed to be double-blind for children, meaning neither the participants nor the researchers will know who is receiving the active treatment or the placebo. For infants, the trial will be open-label, meaning all participants will receive the active treatment. The study aims to provide valuable information on the potential benefits of tralokinumab for young patients with atopic dermatitis.

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 treatment phase

    Upon joining the trial, the child will begin treatment with either tralokinumab or a placebo. Both are administered as a solution for injection using a pre-filled syringe.

    The injections are given under the skin, a method known as subcutaneous use.

  2. Step 2

    Combination with topical treatment

    In addition to the injections, the child will use topical corticosteroids (TCS) as part of the treatment. These are creams or ointments applied directly to the skin to help manage symptoms of atopic dermatitis.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, the child's response to the treatment will be closely monitored. This includes regular assessments of the skin condition, symptom severity, and any changes in quality of life.

    The primary goal is to determine if the combination of tralokinumab and TCS is more effective than the placebo and TCS in controlling skin symptoms.

  4. Step 4

    Duration of treatment

    The treatment phase of the trial is planned to last for 16 weeks. During this time, the child's progress will be evaluated at various intervals to track improvements or any side effects.

  5. Step 5

    Final evaluation

    At the end of the 16-week period, a final assessment will be conducted to evaluate the overall effectiveness of the treatment. This includes measuring the extent of skin improvement and any reduction in itching or scratching.

Who can join the trial?

12 criteria

  • The patient must have a signed and dated informed consent form.
  • The patient should be between 6 months and less than 12 years old at the time of screening.
  • The patient must weigh at least 9 kilograms at the time of screening.
  • The patient must have a diagnosis of **Atopic Dermatitis (AD)**, which is a skin condition, according to specific criteria.
  • The patient should have a history of **Atopic Dermatitis** for at least 12 months if they are 6 years or older, or at least 3 months if they are between 6 months and less than 6 years old.
  • The patient must have shown an inadequate response to mid-strength **Topical Corticosteroids (TCS)**, which are creams or ointments used to treat skin conditions, within 6 months before the screening visit.
  • The patient must have **Atopic Dermatitis** affecting at least 10% of their body surface area at screening and baseline.
  • The patient must have an **Eczema Area and Severity Index (EASI)** score of at least 16 at screening and baseline. This is a measure of the severity of eczema.
  • The patient must have an **Investigator's Global Assessment (IGA)** score of at least 3 at screening and baseline. This is a scale used to assess the overall severity of the skin condition.
  • For children aged 6 years or older, the average score for the worst itch must be 4 or higher. For children under 6 years, the average score for scratching must be 4 or higher during the week before the start of the trial.
  • The patient and their caregiver(s) must be able to attend clinic visits and follow the trial requirements and procedures.
  • Female patients who can have children and are sexually active must agree to use a highly effective method of birth control during the trial and for 16 weeks after stopping the treatment.

Who cannot join the trial?

10 criteria

  • Children younger than 2 years old cannot participate.
  • Children 12 years old or older cannot participate.
  • Participants must not have any other skin conditions that could interfere with the study.
  • Participants should not have any serious health issues that could affect their safety during the study.
  • Participants must not have had any recent infections that could impact the study results.
  • Participants should not be taking any medications that could interfere with the study treatment.
  • Participants must not have any known allergies to the study medication or its ingredients.
  • Participants should not have participated in another clinical trial recently.
  • Participants must not have any conditions that could make it difficult to follow the study procedures.
  • Participants should not have a history of drug or alcohol abuse.
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Investigated drugs

  • Tralokinumab

    is a medication being studied for its ability to help control the symptoms of moderate-to-severe atopic dermatitis, a type of eczema, in children and infants. It is used in combination with topical corticosteroids to see if it can provide better relief from skin issues compared to using topical corticosteroids alone. The trial is focused on children aged 2 to under 12 years and aims to assess improvements in skin condition, itching, and overall quality of life for both the children and their caregivers.

  • Topical Corticosteroids

    are creams or ointments applied directly to the skin to reduce inflammation and relieve symptoms of atopic dermatitis, such as redness, swelling, and itching. In this trial, they are used alongside tralokinumab to determine if the combination is more effective than using topical corticosteroids by themselves. The goal is to improve the skin condition and quality of life for children with moderate-to-severe atopic dermatitis.

What is already known about the treatment

Tralokinumab – Tralokinumab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe atopic dermatitis in children and infants. It is a monoclonal antibody that works by targeting and neutralizing interleukin-13, a protein involved in the inflammatory process of atopic dermatitis. This medication is classified as an immunomodulator and is being evaluated for its ability to improve skin condition and reduce symptoms such as itching and skin lesions.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by inflamed, itchy, and red patches of skin. It often begins in childhood and can persist into adulthood, though the severity and specific symptoms can vary over time. The skin may become dry, cracked, and prone to infections due to frequent scratching. Flare-ups can be triggered by environmental factors, allergens, or stress. The condition is associated with a compromised skin barrier, leading to increased sensitivity and irritation. It is commonly seen in individuals with a family history of allergies or asthma.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IVTrial ID2023-503630-44-00Protocol codeLP0162-1336Estimated enrolment191 patientsSponsorLeo Pharma A/S

sourced from the EU Clinical Trials Register and site verification

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