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Study of Lebrikizumab and Topical Corticosteroids for Children and Teens with Moderate-to-Severe Atopic Dermatitis

Fast replyRegistered drugNo placebo
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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 medication called Lebrikizumab on children and adolescents aged 6 months to under 18 years who have moderate-to-severe atopic dermatitis, commonly known as eczema. Eczema is a condition that makes the skin red, inflamed, and itchy. The study aims to evaluate how effective and safe Lebrikizumab is when used alongside topical corticosteroids, which are creams or ointments applied to the skin to reduce inflammation and irritation.

Participants in the study will receive either Lebrikizumab or a placebo, which is a substance with no active medication, to compare the outcomes. The treatment will be administered as a solution for injection under the skin. The study will monitor the participants over a period to assess improvements in their skin condition and any potential side effects. The goal is to determine if Lebrikizumab can significantly improve the symptoms of eczema compared to the placebo.

In addition to Lebrikizumab, the study will also consider the effects of other treatments such as glucocorticoids, which are oral medications that help reduce inflammation, and various types of topical corticosteroids, which vary in potency from weak to very potent. The study will help understand the best treatment options for managing moderate-to-severe eczema in young patients.

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, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age and weight requirements, and a history of atopic dermatitis.

    A parent or legal guardian must provide consent for participation. Additional conditions are assessed to ensure suitability for the study.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to evaluate the current state of atopic dermatitis. This includes measuring the severity and extent of the condition.

    The assessment helps establish a starting point for monitoring changes throughout the study.

  3. Step 3

    Treatment phase

    Participants receive either lebrikizumab or a placebo. Lebrikizumab is administered as a solution for injection under the skin (subcutaneous injection).

    The treatment is combined with topical corticosteroids (TCS) applied to the skin. The frequency and dosage of the medications are determined by the study protocol.

  4. Step 4

    Regular follow-up visits

    Regular follow-up visits are scheduled to monitor progress and assess the effectiveness of the treatment.

    During these visits, the severity of atopic dermatitis is evaluated, and any side effects or concerns are addressed.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment.

    The results are compared to the baseline assessment to determine any improvements or changes in the condition.

Who can join the trial?

5 criteria

  • Have Atopic Dermatitis (also known as Eczema) for at least 6 months if younger than 6 years old or 1 year if older than 6 years.
  • Be between 6 months to 6 years old and weigh over 6 kilograms (about 13 pounds).
  • Be between 12 to 18 years old and weigh less than 40 kilograms (about 88 pounds).
  • A parent or legal guardian must be able to sign the consent document and follow the guidelines of the study.
  • Meet other additional conditions at the time of the first visit.

Who cannot join the trial?

6 criteria

  • You participated in a similar research study using a similar type of medicine or used a forbidden treatment within the last 2 to 8 weeks.
  • You are currently pregnant (expecting a baby) or breastfeeding (feeding a baby with milk from the breast).
  • You have previously had an allergic reaction (the body's harmful response to a substance) to the medicine being studied or to the ointments or creams used during the trial.
  • You have a severe infection (a serious illness caused by germs like bacteria or viruses) that is currently active or requires strong antibiotics (medicines used to kill bacteria).
  • You have a history of, or are currently living with, a medical condition that your doctor thinks might make participating in this study unsafe for you.
  • You have an addiction (a physical or mental dependence) to drugs or alcohol.
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Investigated drugs

Lebrikizumab 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 works by targeting a specific protein in the body that is involved in the inflammation process. By blocking this protein, lebrikizumab may help reduce the symptoms of atopic dermatitis, such as itching and skin irritation. In this clinical trial, lebrikizumab is being tested to see how well it works and how safe it is for children and teenagers who have this skin condition.

What is already known about the treatment

Lebrikizumab – Lebrikizumab is administered as an injection under the skin and is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe atopic dermatitis, also known as eczema, in children and adolescents. This medication is not yet widely available in medical practice, as it is still undergoing research to confirm its safety and efficacy. Lebrikizumab works by targeting a specific protein in the body that plays a role in inflammation, helping to reduce the symptoms of eczema. It is classified as a monoclonal antibody, which is a type of drug designed to interact with specific molecules in the immune system.

Investigated diseases

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood but can occur at any age. The disease progresses through cycles of flare-ups and remissions, where symptoms can worsen and then improve. During flare-ups, the skin may become more inflamed, leading to increased itching and discomfort. Over time, repeated scratching can cause the skin to thicken and become more susceptible to infections. The condition is associated with a compromised skin barrier and an overactive immune response.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501476-25-00Estimated enrolment360 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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