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Study on the Effectiveness of Ruxolitinib Cream for Adults with Moderate 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 treatment for Atopic Dermatitis, a common skin condition that causes red, itchy, and inflamed skin. The treatment being tested is a cream containing Ruxolitinib, which is applied to the skin. The study aims to determine how effective and safe this cream is for adults who have moderate atopic dermatitis and have not responded well to other treatments like topical corticosteroids or topical calcineurin inhibitors.

Participants in the study will be randomly assigned to use either the Ruxolitinib cream or a similar cream without the active ingredient, known as a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the active treatment or the placebo. This helps ensure that the results are unbiased. The study will last for several weeks, during which participants will apply the cream to their skin and attend regular check-ups to monitor their progress and any side effects.

The main goal of the study is to see if the Ruxolitinib cream can significantly improve the symptoms of atopic dermatitis, such as reducing the severity of skin inflammation and itchiness. Participants' skin condition will be assessed at various points throughout the study to track improvements. The study will also gather information on any side effects experienced by participants to ensure the treatment is safe. This research could potentially lead to a new treatment option for those suffering from moderate 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

    Joining the study

    Upon joining the study, the participant will be required to stop using any other treatments for atopic dermatitis, except as specified in the study protocol.

    Participants must agree to avoid pregnancy or fathering children during the study and for a specified period after the last application of the study cream.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility, which includes a diagnosis of moderate atopic dermatitis and specific scores on various scales measuring the severity of the condition.

  3. Step 3

    Treatment phase

    Participants will be randomly assigned to receive either the ruxolitinib cream or a vehicle cream without the active substance.

    The cream is applied to the skin (cutaneous use) as directed by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants will be monitored regularly to assess the effectiveness and safety of the treatment.

    The primary goal is to achieve significant improvement in the severity of atopic dermatitis by Week 8, as measured by specific clinical scales.

  5. Step 5

    Completion of the study

    The study is expected to conclude by December 2025, with final assessments conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Must be an adult aged 18 years or older.
  • Agree to stop using all treatments for **Atopic Dermatitis** (AD) during the study, except for specific exceptions mentioned in the study protocol.
  • Must agree to avoid pregnancy, breastfeeding, or fathering children during the study and for a certain period after the last use of the study cream. This includes using approved methods to prevent pregnancy.
  • Must be able to understand and willing to sign an **Informed Consent Form** (ICF), which is a document explaining the study and confirming your agreement to participate.
  • Must have a diagnosis of **Atopic Dermatitis** (AD) according to specific criteria set by Hanifin and Rajka in 1980.
  • Must have had AD for at least 2 years.
  • Must have an **Investigator's Global Assessment** (IGA) score of 3 at the start of the study. This score helps measure the severity of AD.
  • Must have an **Eczema Area and Severity Index** (EASI) score greater than 7 at the start of the study. This score measures the extent and severity of eczema.
  • Must have an **Itch Numeric Rating Scale** (NRS) score of 4 or higher at the start of the study. This score measures the intensity of itching over the past week.
  • Must have **Atopic Dermatitis** affecting at least 10% and up to 20% of the body surface area, excluding the scalp, at the start of the study.
  • Must have a **Dermatology Life Quality Index** (DLQI) score greater than 10 at the start of the study. This score measures the impact of skin disease on your life.
  • Must have a recent history (within the last 12 months) of not responding well, being intolerant, or having a reason not to use **Topical Corticosteroids** (TCSs) and **Topical Calcineurin Inhibitors** (TCIs), which are common treatments for AD.

Who cannot join the trial?

7 criteria

  • Participants who have a known allergy or sensitivity to the study medication or its ingredients.
  • Individuals with a history of certain skin conditions that might interfere with the study, such as severe forms of eczema.
  • People who have used certain medications that could affect the study results, like strong steroids, within a specific time before the study starts.
  • Participants with any other medical condition that the study doctors believe could make it unsafe for them to participate.
  • Individuals who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
  • People who are currently participating in another clinical trial or have recently participated in one.
  • Participants who have a history of not following medical advice or treatment plans, which could affect the study's results.
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Investigated drugs

Ruxolitinib Cream is a topical medication used in this clinical trial to treat adults with moderate atopic dermatitis. It is applied directly to the skin and works by reducing inflammation and itching associated with the condition. The trial aims to determine how effective and safe this cream is for people who have not responded well to other treatments like topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs), or for those who cannot use these treatments due to intolerance or other reasons.

What is already known about the treatment

Ruxolitinib Cream – This medication is applied topically as a cream and is currently being studied in clinical trials for its effectiveness in treating moderate atopic dermatitis. It is in the late stages of clinical research, specifically a Phase 3b trial, which evaluates its safety and efficacy. The main therapeutic use of ruxolitinib cream is for individuals with moderate atopic dermatitis who have not responded well to other treatments like topical corticosteroids or calcineurin inhibitors. At the molecular level, ruxolitinib works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood but can occur at any age. The skin may become red, swollen, and cracked, and in some cases, blisters may form. The condition tends to flare periodically and then subside. It is commonly associated with other allergic conditions like asthma and hay fever. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505433-27-00Protocol codeINCB 18424-326Estimated enrolment225 patientsSponsorIncyte Corp.

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