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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 trial 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 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 is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the Ruxolitinib cream and who is receiving the vehicle cream, to ensure unbiased results.

Throughout the study, participants will apply the cream to their skin as directed and attend regular check-ups to monitor their progress. The study will last for several weeks, with key assessments at different points to evaluate improvements in symptoms. The main goal is to see if there is a significant reduction in itchiness and skin lesions after using the Ruxolitinib cream compared to the vehicle cream. Participants' experiences and any changes in their condition will be carefully recorded to help determine the treatment's effectiveness and safety.

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 required to sign a document called an informed consent form. This form confirms your understanding of the study and your willingness to participate.

    You must be at least 18 years old and have been diagnosed with a skin condition called prurigo nodularis for at least three months.

  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 and a specific score on a scale measuring itch severity.

    Women of childbearing potential will undergo a pregnancy test to ensure they are not pregnant before starting the treatment.

  3. Step 3

    Treatment phase

    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 daily, once in the morning and once in the evening, for a period of 12 weeks.

  4. Step 4

    Follow-up assessments

    Throughout the study, you will have regular follow-up assessments to monitor your response to the treatment. These assessments will occur at specific intervals, including at weeks 4 and 12.

    The primary goal is to see if there is a significant reduction in your itch severity score by week 12.

  5. Step 5

    Completion of the study

    At the end of the 12-week treatment period, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

    You will be asked to provide feedback on your experience and any changes in your condition.

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 body area affected must be 20% or less.
  • 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 score measures the intensity of itchiness over a week.)
  • Must agree to avoid pregnancy or fathering children during the study and for a period after the study ends:
    • Male participants must take precautions to avoid fathering children from screening through 90 days after the last application of the study cream and must not donate 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 screening through 30 days after the last application of the study cream and must not donate eggs during this time.
    • Female participants who are not able to become pregnant are eligible.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Prurigo Nodularis cannot participate. This is a skin condition that causes hard, itchy lumps.
  • Patients who are younger than 18 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent themselves, cannot 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 a skin condition called Prurigo Nodularis. This condition causes itchy, hard lumps on the skin. The cream works by reducing inflammation and itchiness, which may help improve the appearance and feel of the skin affected by this condition.

What is already known about the treatment

Ruxolitinib – Ruxolitinib is administered as a cream applied directly to the skin, specifically for treating Prurigo Nodularis, a condition characterized by itchy nodules on the skin. It is currently being studied in a phase 3 clinical trial to assess its effectiveness and safety for this condition. The main therapeutic use of ruxolitinib cream is to alleviate the symptoms of Prurigo Nodularis. At the molecular level, ruxolitinib works by inhibiting certain enzymes called Janus kinases (JAKs), which play a role in the inflammatory process that contributes to the skin condition. It is classified pharmacologically as a JAK inhibitor.

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 and inflammation. 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 can persist for many years, with periods of improvement and worsening.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501621-20-00Protocol codeINCB18424-319Estimated enrolment180 patientsSponsorIncyte Corp.

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