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Study of Baricitinib for Children and Adolescents 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 the effects of a medication called Baricitinib in children and teenagers who have a skin condition known as atopic dermatitis, which is often referred to as eczema. Atopic dermatitis is a condition that causes the skin to become red, itchy, and inflamed. The purpose of the study is to determine if Baricitinib is effective and safe for treating this condition in young patients.

Participants in the study will receive either Baricitinib or a placebo, which is a substance with no active medication. The study will be conducted over a period of time, during which the participants will be monitored to see how their skin condition responds to the treatment. The study will also involve the use of other treatments like Hydrocortisone creams or ointments as background therapy, which are commonly used to reduce inflammation and relieve itching in skin conditions.

The study aims to gather information on how well Baricitinib works in improving the symptoms of atopic dermatitis and to ensure its safety for use in children and adolescents. Participants will be required to visit the study site regularly for check-ups and assessments to track their progress and any changes in their condition. The study is designed to provide valuable insights into the treatment of atopic dermatitis in younger populations.

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

    Joining the study

    Upon joining the study, the participant will be assessed to ensure they meet the criteria for participation. This includes having a diagnosis of moderate to severe atopic dermatitis for a specified duration and having an inadequate response to existing treatments.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's current health status and the severity of their atopic dermatitis. This may involve physical examinations and questionnaires.

  3. Step 3

    Treatment phase

    Participants will be randomly assigned to receive either the study drug Baricitinib or a placebo. Baricitinib is administered orally, and the dosage will be determined by the study protocol.

    In addition to Baricitinib, participants may use Hydrocortisone cream or ointment for cutaneous application as needed to manage symptoms.

  4. Step 4

    Ongoing monitoring

    Throughout the study, participants will be monitored regularly to assess the effectiveness and safety of the treatment. This includes regular visits to the study site for evaluations and possible adjustments to the treatment plan.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the overall outcomes of the treatment. This will include a review of the participant's health status and any changes in the severity of atopic dermatitis.

Who can join the trial?

5 criteria

  • Participants must be at or above the 5th percentile of weight for their age. This means their weight should be within a healthy range for their age group.
  • Participants should have been diagnosed with moderate to severe atopic dermatitis for at least 12 months if they are 6 years old or older, or for at least 6 months if they are between 2 and 6 years old. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
  • Participants must have had an inadequate response or intolerance to existing topical medications within the 6 months before the screening. Topical medications are treatments applied directly to the skin.
  • Participants should be willing to stop using certain treatments for eczema during a washout period. A washout period is a time when participants stop using certain medications to clear them from their system.
  • Participants must agree to use emollients daily. Emollients are moisturizing treatments applied to the skin to help manage dryness and irritation.

Who cannot join the trial?

7 criteria

  • Children and teenagers who have a different skin condition other than atopic dermatitis cannot participate. Atopic dermatitis is a type of skin condition that causes itchy and inflamed skin.
  • Participants who are not within the age range specified for the study cannot join. The study is for children and teenagers.
  • Individuals who have other health conditions that might interfere with the study drug or its effects cannot take part.
  • Participants who are taking certain medications that might affect the study drug cannot be included.
  • Children and teenagers who have had a recent infection or illness that could affect the study results cannot participate.
  • Participants who have a history of allergic reactions to similar medications cannot join the study.
  • Individuals who are unable to follow the study procedures or attend the required visits cannot be part of the study.
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Investigated drugs

Baricitinib is a medication being studied to see if it is effective and safe for children and teenagers with moderate-to-severe atopic dermatitis, which is a type of skin condition. The trial aims to understand how well this medication works in improving the symptoms of atopic dermatitis and to ensure it is safe for use in younger patients.

What is already known about the treatment

Baricitinib – Baricitinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness and safety in treating moderate-to-severe atopic dermatitis, particularly in pediatric patients. The medication is primarily indicated for conditions like atopic dermatitis and works by inhibiting specific enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. Baricitinib is classified as a JAK inhibitor, a type of medication that helps reduce inflammation by blocking the activity of these enzymes.

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, sometimes leading to secondary infections due to scratching. Environmental factors, allergens, and stress can trigger or worsen symptoms. The condition is associated with a malfunction in the skin barrier and an overactive immune response. It is not contagious and varies in severity among individuals.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503898-38-00Protocol codeI4V-MC-JAIPEstimated enrolment556 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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