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Study on the Safety and Effectiveness of Upadacitinib and Dupilumab for Children Aged 2 to 12 with Moderate to Severe Atopic Dermatitis

Verified siteRegistered 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 treatment of Atopic Dermatitis, a condition commonly known as eczema, which causes the skin to become itchy, red, and inflamed. The study involves two treatments: Upadacitinib, which is taken as an oral solution or a modified-release tablet, and Dupilumab, which is given as a solution for injection. The purpose of the study is to compare the safety and effectiveness of these two treatments in children aged 2 to less than 12 years who have moderate to severe atopic dermatitis.

Participants in the study will receive either Upadacitinib or Dupilumab. The study will last for several weeks, during which the children will be monitored to see how their skin condition improves and to check for any side effects. The study aims to find out which treatment works better in reducing the symptoms of atopic dermatitis, such as the extent and severity of the eczema, and to ensure that the treatments are safe for use in children.

Throughout the study, the children will have regular check-ups to assess their progress. The main goal is to see if there is a significant reduction in the eczema symptoms by the end of the study period. This research is important for understanding how these treatments can help manage atopic dermatitis in young children and improve their quality of life.

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, you will be assigned to receive either upadacitinib or dupilumab. These medications are used to treat moderate to severe atopic dermatitis, a skin condition characterized by red, itchy, and inflamed skin.

  2. Step 2

    Medication administration

    If you are assigned to upadacitinib, you will take it as an oral solution or a modified-release tablet. The specific dosage and frequency will be determined by the study team.

    If you are assigned to dupilumab, it will be administered as a subcutaneous injection. The dosage and frequency will be according to the study protocol.

  3. Step 3

    Treatment duration

    The treatment will continue for a specified period, with regular assessments to monitor your response to the medication and any side effects. The primary assessment will occur at week 16.

  4. Step 4

    Regular assessments

    Throughout the study, you will undergo regular assessments to evaluate the effectiveness of the treatment. This includes measuring the reduction in eczema area and severity index score (EASI) and other health indicators.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a final evaluation will be conducted to assess the overall effectiveness and safety of the medication. This will help determine the percentage of participants achieving significant improvement in their condition.

Who can join the trial?

12 criteria

  • The child must be between 2 and less than 12 years old at the start of the study.
  • The child must weigh at least 10 kg and have a weight and height above the 5th percentile for their age based on local growth charts.
  • The child must have a certain level of disease activity, which includes:
    • An EASI score of 16 or higher. (EASI is a tool used to measure the severity of eczema.)
    • A vIGA-AD score of 3 or higher. (vIGA-AD is a scale used to assess the severity of eczema.)
    • At least 10% of the body surface area affected by eczema.
    • A weekly average score of 4 or higher on a daily itch scale reported by the child or caregiver.
    • The child must meet at least one of the following criteria:
      • For children in countries other than the US: A history of not responding well or having a bad reaction to topical treatments like creams or ointments, or if these treatments are not suitable for them.
      • For children who have not used dupilumab before: A history of not responding well to other systemic treatments (treatments that affect the whole body) for eczema, or if these treatments are not suitable for them.
      • A history of not responding well to at least two courses of oral corticosteroid therapy (a type of medication) given for 14 days or more within 6 months before the study, or if symptoms returned within 4 months after stopping the medication.
      • For children who have used dupilumab before: Prior use of dupilumab without a history of not responding well or having a bad reaction, but stopped for non-medical reasons like insurance issues.
      • For children who did not respond well or had a bad reaction to dupilumab, or if dupilumab is not suitable for them, and have a history of not responding well or having a bad reaction to topical treatments.
      • If the child has eczema around the eyes, they must be willing to have an eye examination before starting the study.

Who cannot join the trial?

10 criteria

  • Patients who have any other skin conditions that might interfere with the study.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments for their skin condition within a specific time frame before the study starts.
  • Patients who have any serious health conditions that could affect their participation in the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of certain infections that could be worsened by the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of alcohol or drug abuse.
  • Patients who have been vaccinated with certain vaccines within a specific time frame before the study starts.
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Investigated drugs

  • Upadacitinib

    is a medication used in this clinical trial to help treat children with moderate to severe atopic dermatitis, which is a type of eczema. It works by targeting specific pathways in the immune system that are involved in causing inflammation and itching in the skin. By doing so, it aims to reduce the symptoms of atopic dermatitis, such as redness, swelling, and itching, making the skin feel more comfortable and improving the quality of life for the children participating in the trial.

  • Dupilumab

    is another medication being tested in this trial for children with moderate to severe atopic dermatitis. It is designed to block certain proteins in the body that can cause inflammation and lead to the symptoms of eczema. By blocking these proteins, dupilumab helps to decrease the inflammation and itching associated with atopic dermatitis, potentially leading to clearer skin and relief from discomfort for the children involved in the study.

What is already known about the treatment

  • Upadacitinib

    Upadacitinib is administered orally in the form of tablets and is currently being studied for its effectiveness and safety in treating children with moderate to severe atopic dermatitis, a type of eczema. It is a medication that is gaining attention in medical literature for its potential benefits in managing this skin condition. The main therapeutic indication for upadacitinib is to reduce inflammation and alleviate symptoms associated with atopic dermatitis. At the molecular level, it works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. Upadacitinib is classified as a JAK inhibitor, a type of medication that helps control immune responses and inflammation.

  • Dupilumab

    Dupilumab is administered through subcutaneous injection and is an established treatment in the medical field for atopic dermatitis, particularly in children and adults with moderate to severe forms of the condition. It is widely recognized in medical literature for its effectiveness in reducing symptoms of eczema. The main therapeutic indication for dupilumab is to manage and improve skin inflammation and itching associated with atopic dermatitis. At the molecular level, it works by blocking specific proteins, interleukin-4 and interleukin-13, which are involved in the inflammatory process. Dupilumab is classified as a monoclonal antibody, a type of medication that targets specific pathways in the immune system to reduce inflammation.

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. The skin may become dry, cracked, and prone to infections due to frequent scratching. Flare-ups can occur, leading to more intense symptoms and discomfort. The condition is associated with a malfunction in the skin barrier and immune system, which can be influenced by genetic and environmental factors. Over time, the skin may thicken and develop a leathery texture due to repeated irritation and inflammation.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504713-76-00Protocol codeM17-380Estimated enrolment735 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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