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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Hopital Prive D Antony Antony France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Santa Sp. z o.o. Lodz Poland
Clinical Research Group Sp. z o.o. Warsaw Poland
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
PRATIA MCM Kraków Cracow Poland
Pezcszxvk Icusgzea Mhpujpbf Mnmjpvytasbi Slthx Wuhgaadetwga I Aqpekunnubxhl Warsaw Poland
Ckbigtsvt Udbborfjrrxdou Sgwqcueaq Woluwe-Saint-Lambert Belgium
Brxixe Zqluhlvemj Bergen Op Zoom The Netherlands
Hiygczndrhfzer Dx Med Mezgcxkb Hilnlggy Witten Germany
Alillkiqw Unv Amsterdam The Netherlands
Trwsmapwjjh upj Sgejvmyeyyo Bwqhgkvt Gkoq Bad Bentheim Germany
Aqkmofi Skubgdueu Lzxeuz Akolncet Sqnguje Lfivavcqjixzmb L'aquila Italy
Ivqstzwl dd Cozzhrzqubvh Hfvwxuaygxc Uojvntqalvjob di Swpva Endlyuh (xaaxych Saint Priest En Jarez France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
06.09.2023
France France
Not recruiting
06.09.2023
Germany Germany
Not recruiting
06.09.2023
Italy Italy
Not recruiting
06.09.2023
Poland Poland
Not recruiting
06.09.2023
Spain Spain
Not recruiting
06.09.2023
The Netherlands The Netherlands
Not recruiting
06.09.2023

Trial locations

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.

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 ID:
2022-501621-20-00
Protocol code:
INCB18424-319
Trial Phase:
Therapeutic confirmatory (Phase III)

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