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Study on the Effectiveness and Safety of Ruxolitinib Cream for Patients with Prurigo Nodularis

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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 a skin condition called Prurigo Nodularis. This condition is characterized by itchy, hard lumps on the skin. The study will test the effectiveness and safety of a treatment using Ruxolitinib cream. Ruxolitinib is a medication applied directly to the skin, and it is being evaluated to see if it can help reduce the symptoms of Prurigo Nodularis.

The purpose of the study is to determine how well the Ruxolitinib cream works in treating Prurigo Nodularis. Participants in the study will be randomly assigned to receive either the Ruxolitinib cream or a vehicle cream, which looks and feels like the Ruxolitinib cream but does not contain the active medication. This helps researchers compare the effects of the actual medication against a cream without the active ingredient.

The study will last for several weeks, during which participants will apply the cream to their skin as directed. Throughout the study, participants will be monitored to assess any changes in their skin condition and to ensure their safety. The study aims to provide valuable information on whether Ruxolitinib cream can be an effective treatment option for those suffering from Prurigo Nodularis.

The research process

The trial runs in 7 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 required to sign a document called an informed consent form. This document confirms that you understand the study and agree to participate.

    You must be at least 18 years old and have been diagnosed with prurigo nodularis for at least three months before the study begins.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the study criteria. This includes having at least six itchy skin lesions on two different body areas, such as both legs.

    Your skin condition will be evaluated using a scoring system, and you will need to have a certain score to participate.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either the ruxolitinib cream or a vehicle cream, which looks the same but does not contain the active ingredient.

    The ruxolitinib cream is applied to the skin twice a day, once in the morning and once in the evening, for a period of 12 weeks.

  4. Step 4

    Weekly assessments

    Throughout the study, you will have weekly assessments to monitor your progress. This includes evaluating the severity of your skin condition and any changes in symptoms.

    You will be asked to report any side effects or changes in your condition during these assessments.

  5. Step 5

    Primary evaluation

    At week 12, a primary evaluation will be conducted to determine the effectiveness of the treatment. This involves measuring the improvement in your skin condition using a specific scoring system.

    The goal is to achieve a significant reduction in the severity of your symptoms.

  6. Step 6

    Secondary evaluations

    Additional evaluations will be conducted at week 4 and day 7 to assess early responses to the treatment.

    These evaluations help to understand how quickly the treatment is working and its overall effectiveness.

  7. Step 7

    End of study

    At the end of the study, you will have a final assessment to review your overall experience and any changes in your condition.

    You will be provided with information on the next steps and any follow-up care that may be needed.

Who can join the trial?

9 criteria

  • Ability to understand and willingness to sign a written consent form for the study.
  • Must be at least 18 years old at the time of signing the consent form.
  • Must have been diagnosed with Prurigo Nodularis (PN) for at least 3 months before the screening.
  • Must have at least 6 itchy skin bumps on at least 2 different body areas (like the right and left leg) at screening and baseline. The total area of skin affected must be 20% or less of the body.
  • Must have an IGA-CPG-S score of 2 or higher at screening and baseline. (This is a score used to measure the severity of the skin condition.)
  • Must have a WI-NRS score of 7 or higher at baseline. (This is a score that measures the intensity of itchiness over a week before starting the study.)
  • Must be willing to avoid pregnancy or fathering children during the study and for a period after the study ends:
    • Male participants must agree to take precautions to avoid fathering children from the start of the study through 90 days after the last application of the study cream. They must also refrain from donating sperm during this time.
    • Female participants who can become pregnant must have a negative pregnancy test at screening and before the first application of the study cream. They must agree to take precautions to avoid pregnancy from the start of the study through 30 days after the last application of the study cream and must refrain from donating eggs during this time.
    • Female participants who are not able to become pregnant are eligible.

Who cannot join the trial?

7 criteria

  • Participants cannot join if they have any other skin conditions that might interfere with the study.
  • Participants who are currently using other treatments for Prurigo Nodularis that might affect the study results are not allowed.
  • Participants with a history of allergic reactions to similar creams or any of its ingredients cannot participate.
  • Pregnant or breastfeeding women are not eligible to join the study.
  • Participants with any serious health conditions that could affect their safety during the study are excluded.
  • Participants who have been part of another clinical trial recently may not be eligible.
  • Individuals who are unable to follow the study procedures or attend the required visits are not allowed to participate.
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Investigated drugs

Ruxolitinib Cream is a topical medication used in this clinical trial. It is applied directly to the skin and is being tested for its effectiveness in treating Prurigo Nodularis, a skin condition that causes itchy, hard lumps. The cream works by targeting specific pathways in the immune system to reduce inflammation and itchiness, helping to improve the skin's appearance and comfort for those affected by this condition.

What is already known about the treatment

Ruxolitinib Cream – This medication is applied topically, meaning it is spread directly onto the skin, and is used to treat Prurigo Nodularis, a condition characterized by itchy nodules on the skin. Ruxolitinib cream is currently being studied in clinical trials to assess its effectiveness and safety for this condition. It works by inhibiting certain enzymes in the body that are involved in the inflammatory process, helping to reduce itching and inflammation. Ruxolitinib belongs to a class of drugs known as Janus kinase (JAK) inhibitors, which are used to manage various inflammatory conditions.

Investigated diseases

Prurigo Nodularis – Prurigo Nodularis is a chronic skin condition characterized by the presence of hard, itchy nodules on the skin. These nodules are often intensely itchy, leading to frequent scratching, which can worsen the condition. The nodules typically appear on the arms, legs, and other areas that are easy to reach. Over time, the skin around the nodules may become thickened and discolored due to repeated scratching. The exact cause of Prurigo Nodularis is not well understood, but it is often associated with other conditions such as eczema or liver disease. The condition tends to persist for a long time and can significantly impact the quality of life due to the intense itching.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502461-23-00Protocol codeINCB18424-320Estimated enrolment207 patientsSponsorIncyte Corp.

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