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Study of Ruxolitinib Cream for Children and Adolescents Ages 6-17 with Moderate Atopic Dermatitis Who Did Not Respond Well to Standard Treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children and teenagers aged 6 to 18 years who have moderate atopic dermatitis, a chronic inflammatory skin condition that causes itchy, red, and inflamed skin. The research evaluates a medication called ruxolitinib cream (also known as INCB018424 or Opzelura) compared to a cream without active ingredients (vehicle cream) in patients whose condition has not improved with standard treatments or who cannot use them.

The purpose of this research is to determine how well ruxolitinib cream works in treating moderate atopic dermatitis in young patients. During the study, participants will apply either ruxolitinib cream or the vehicle cream to affected areas of their skin, excluding the scalp. The treatment period lasts for 8 weeks, followed by an extended observation period.

The study will monitor changes in skin condition, including improvements in rash coverage, intensity of itching, and overall disease severity. Blood samples will be collected from some participants to measure how much of the medication enters the bloodstream. The research will also track any side effects that may occur during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your atopic dermatitis (a skin condition causing itchy, inflamed skin) will be evaluated to confirm it meets the study criteria

    The affected area must cover between 3% and 20% of your body surface (excluding scalp)

    Your condition must be present for at least 3 months if you are 6-11 years old, or 2 years if you are 12-17 years old

  2. Step 2

    Treatment phase - First 8 weeks

    You will receive either ruxolitinib cream or a cream without active ingredient (vehicle cream) to apply to affected skin areas

    The cream will be applied directly to the skin

    Your skin condition will be monitored using several assessment tools:

    - EASI score (measures the extent and severity of affected skin)

    - IGA score (doctor's assessment of disease severity)

    - Itch rating (how intense your itching is)

  3. Step 3

    Evaluations during treatment

    Your progress will be checked at week 2, 4, and 8

    Blood samples will be collected at week 2 and 8 to measure medication levels

    You will complete questionnaires about your quality of life and symptoms

    Your height, weight, and vital signs will be monitored

    Laboratory tests will be performed to check your blood counts and chemistry

  4. Step 4

    Disease control period

    If your skin improves during the first phase, you may continue to the next phase

    During this period, your skin condition will be monitored for any return of symptoms

    The amount of cream used will be tracked

    Regular assessments will continue to evaluate your skin condition

Who can join the trial?

9 criteria

  • Age between 6 and 18 years old at the first visit
  • If sexually active, must be willing to use appropriate birth control methods during the study (except for children who have not reached puberty)
  • Must be able to understand and willing to sign an informed consent form (parents or legal guardians must sign for minors)
  • Must have Atopic Dermatitis diagnosed according to specific medical criteria
  • Must have had Atopic Dermatitis for: - At least 3 months for children aged 6-11 years - At least 2 years for children aged 12-17 years
  • Must have a moderate level of skin symptoms, measured by: - An EASI score (a measure of disease severity) greater than 7 - An IGA score (doctor's assessment) of 3 - Affected body surface area between 3% and 20% (not including scalp)
  • Must have significant itching, with an average score of 4 or higher on a special scale during the week before the first visit
  • Must have documented proof within the last 12 months that standard skin treatments (topical corticosteroids and calcineurin inhibitors) either: - Did not work well enough - Caused unacceptable side effects - Were not suitable for use in this patient
  • Must agree to stop using other treatments for Atopic Dermatitis during the study period, except those specifically allowed by the study doctors

Who cannot join the trial?

15 criteria

  • History of allergic reactions to ruxolitinib or similar medications
  • Active skin infections that require treatment
  • Current use of medications that could interfere with the study drug
  • Presence of other skin conditions that could interfere with evaluating atopic dermatitis
  • History of skin cancer or current suspicious skin lesions
  • Significant medical conditions that could affect study participation
  • Current participation in other clinical trials
  • Recent use of systemic treatments for atopic dermatitis (medications that affect the whole body)
  • Recent use of light therapy (phototherapy) for skin treatment
  • Pregnancy or breastfeeding
  • Known immune system disorders
  • History of serious infections in the past 3 months
  • Inability to follow study procedures or attend scheduled visits
  • Severe liver or kidney problems
  • Current or recent use of medications that suppress the immune system
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Investigated drugs

  • Ruxolitinib cream

    is a topical medication used to treat moderate atopic dermatitis (eczema). It belongs to a class of drugs called JAK inhibitors, which work by reducing inflammation and itching in the skin. This cream is being studied specifically for children and teenagers aged 6 to 18 years who haven't responded well to, cannot tolerate, or cannot use standard treatments like topical corticosteroids and topical calcineurin inhibitors.

  • Vehicle cream

    is a control product that contains the same base ingredients as the ruxolitinib cream but without the active medication. It's used to compare the effectiveness of the active treatment in clinical trials.

What is already known about the treatment

Ruxolitinib cream – A topical medication applied directly to the skin for treating moderate atopic dermatitis, particularly in children and adolescents aged 6 to 18 years who haven't responded well to traditional treatments. This JAK1/JAK2 inhibitor works by reducing inflammation and itching at the cellular level by blocking specific signaling pathways involved in the immune response. The cream formulation represents a newer approach to treating atopic dermatitis, offering a targeted treatment option that can be applied directly to affected areas of the skin, and has shown promise in clinical trials for patients who haven't found success with conventional treatments like topical corticosteroids or calcineurin inhibitors.

Investigated diseases

Atopic Dermatitis - A chronic inflammatory skin condition that causes red, itchy, and dry patches on the skin. The condition typically develops in early childhood and can persist through adolescence and adulthood. It involves an overactive immune system response that leads to skin barrier dysfunction and inflammation. The affected areas commonly include the face, neck, inside of elbows, behind knees, and hands, with symptoms varying in intensity over time. The condition often follows a pattern of flare-ups and periods of remission, with triggers including stress, certain fabrics, environmental factors, and allergens.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-518156-24-00Protocol codeINCB018424-316Estimated enrolment150 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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