Study on the Effects of Povorcitinib for Patients with Prurigo Nodularis

3 1

What is this study about?

This clinical trial is focused on studying a skin condition called Prurigo Nodularis, which is characterized by itchy, hard lumps on the skin. The study will test a medication named Povorcitinib, which is taken in the form of a tablet. Povorcitinib is being evaluated to see how well it can reduce itchiness and improve skin lesions in people with Prurigo Nodularis.

The purpose of the study is to assess the effectiveness and safety of Povorcitinib. Participants in the study will be randomly assigned to receive either Povorcitinib or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of 48 weeks, during which participants will take the medication orally. Throughout the study, participants will have regular check-ups to monitor their condition and any changes in their symptoms.

By participating in this study, researchers aim to gather important information about how Povorcitinib can help manage the symptoms of Prurigo Nodularis. The ultimate goal is to find a treatment that can provide relief from the intense itching and improve the quality of life for those affected by this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. This includes a review of your medical history and a physical examination.

You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks involved.

2 randomization

After the initial assessments, you will be randomly assigned to one of two groups. One group will receive the active medication, povorcitinib, and the other group will receive a placebo, which looks like the medication but does not contain the active ingredient.

This process is double-blind, meaning neither you nor the study staff will know which group you are in, to ensure unbiased results.

3 medication administration

If you are in the group receiving povorcitinib, you will take the medication orally in the form of a tablet. The dosage and frequency will be specified by the study team.

If you are in the placebo group, you will take the placebo tablet in the same manner as the active medication group.

4 regular follow-up visits

Throughout the study, you will have regular follow-up visits. These visits are scheduled to monitor your health and the effects of the medication.

During these visits, you will undergo various assessments, including physical examinations and questionnaires about your symptoms and any side effects you may experience.

5 end of treatment

The treatment phase of the study will last for a specified duration, after which you will stop taking the study medication.

You will have a final visit to assess your condition and gather any remaining data needed for the study.

6 post-study follow-up

After completing the treatment phase, you may be asked to participate in follow-up visits to monitor your health over a longer period.

These visits help the study team understand the long-term effects of the medication.

Who Can Join the Study?

  • Ability to understand and willingness to sign a written consent form for the study.
  • Age between 18 to 75 years.
  • Have a clinical diagnosis of Prurigo Nodularis (PN) for at least 3 months before the study starts.
  • Experience pruritus, which means itching, with an average itch score of 7 or higher during the 7 days before the study starts.
  • Have 20 or more itchy skin bumps, called pruriginous lesions, on at least 2 different body areas (such as both legs, both arms, or the trunk) at the start of the study.
  • Have an IGA-CPG-S score of 3 or higher at the start of the study. This is a score used to measure the severity of the skin condition.
  • Have a documented history of treatment failure, intolerance, or a reason not to use a previous treatment for PN, except for certain types of inhibitors.
  • Willingness to avoid pregnancy or fathering children during the study, following specific guidelines.
  • Willing and able to follow the study rules and procedures.

Who Cannot Join the Study?

  • Participants cannot join if they have any other skin conditions that might interfere with the study.
  • Participants who have had a recent infection or are currently experiencing an infection cannot participate.
  • Participants who are pregnant or breastfeeding are not eligible to join the study.
  • Participants who have a history of severe allergic reactions to medications are excluded.
  • Participants who are currently using other treatments that might affect the study results cannot participate.
  • Participants with a history of certain serious medical conditions, such as heart disease or liver problems, are not eligible.
  • Participants who have been part of another clinical trial recently may not be eligible to join.
  • Participants who are unable to follow the study procedures or attend the required visits are excluded.

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
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Klinik Hietzing Vienna Austria
Medical Center Teodora EOOD Ruse Bulgaria
Dvhgspdzkyuakqnddxwnpad cbybcj “hovhjgckyukjckx Ekhv Sofia Bulgaria
Uuaohzncwlhgihimvbmak Tjmbipxdd Ayu Tuebingen Germany
Fnzgzpblhf Idbzt Ce Gpehfa Oxtbnbux Mjcizisx Pieyenbwgdj Milan Italy
Adhulqudj Urg Amsterdam The Netherlands
Cbzblaw Ujgazpoqxlrlksxpoayd Bjjddh Kbh Berlin Germany
Pqsunhznipixvdqnsfamw Mapwrdz Marburg Germany
Ulrihhuqtrnnmouqsxhoy Hfhstnlmvo Aef Heidelberg Germany
Hphuymo Physs D Ajuahh Antony France
Uekbypqdcbbs Lyyywmn Leipzig Germany
Umdgjwzljhtfgf Crsalcl Ktksjfcge Gdansk Poland
Ulljqtdhwv Mcihxit Ctwrch Hbzdomigoopkzdzui Hamburg Germany
Ksfmnobs Dqnqrlkg gchwu Dortmund Germany
Uwokktymwwnaybxynyqhb Sifdoisxvgiviajmbh Aff Kiel Germany
Krsybzx Aqhqojimj Sjs z omfs Warsaw Poland
Mljsybl Cjnjpv Mjzetuigwr Pktbsy Ojg Pleven Bulgaria
Ackwtxk Oxpcekrjoitkscbpulqxvykbm Phrpyogfpub Gc Rcmgxipghths Mnsxw Dd Cymnait Catania Italy
Dpelteiiag Chzdfznomgxk Cvpubo Aspopddsf Oyf Sofia Bulgaria
Uwrndgdkyp dktxt snnbn Gvrlaaoy Dflosmcnud Cuwngreykrvatd Cghtnw dt Ssdor e tttofzipqu adtjhkbv Chieti Italy
Uenmgg Mygqxsn Clbbim Euan Plovdiv Bulgaria
Lfyla cwxmeh S C Atjurig Krjhocvm Toqwds Kqyhqtxxami Szczecin Poland
Nsryjdtgtsas Zxrkhp Ovuphn Zwqdfkbrjb Mubnqotyw Lublin Poland
Pcgeywzvhsk Eafxsoejvlve Wroclaw Poland
Dsbwhaxcb Sji z odtc Wroclaw Poland
Uyuxlzvnffaqurrqp Dd Pjfn Pisa Italy
Gpydld Hxdiycvgjwi Da Lt Rsxufi Dx Mlxsayoa Ea Sbp Asgmka Mulhouse France
Hsrnggil Ddrjo Nxqf Romans-Sur-Isere France
Mphvboxlegsxfnduzmkrlkaqjj Hldsrojecnlciosx Halle (Saale) Germany
Hoigxqgj Sxnsi Mavuf Drltm Mqsygomsntjo Perugia Italy
Tegkvgkgarw uoq Sjdvjbpyugo Bgstmsqf Gvvu Bad Bentheim Germany
Pfd Focvgis Alkses Ska z ozwq Katowice Poland
Mbhm snhz Ikzag Ccpteyjnre Atxh Pareheyo Sufqjooptcj Grodzisk Mazowiecki Poland
Cnbugdoz Rplhzuam Gwngz Shs z olxg Warsaw Poland
Moxlvz Midexya Cqesnlk Veldhoven The Netherlands
Dvaalegfohb Amk Cyhpgwnoywf Ckapon Pkriqi Eakq Plovdiv Bulgaria
Aulguii Spwypxdgl Lpqdqu Ayipouto Suwpcra Librlzrgjyxwoq L'aquila Italy
Dv Dbxhykf Rort Smaeonyccgih Martigues France
Nxbhszmjyidj Zubcwm Odgffq Zgxytzlans Senhnqrklxstjmm Ospovrq Dzsmxqgpajsjrsi &wcgtxhclsfhtsroabur Bialystok Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
10.12.2024
Bulgaria Bulgaria
Not recruiting
10.12.2024
France France
Not recruiting
10.12.2024
Germany Germany
Not recruiting
10.12.2024
Italy Italy
Not recruiting
10.12.2024
Poland Poland
Not recruiting
10.12.2024
The Netherlands The Netherlands
Not recruiting
10.12.2024

Trial locations

Povorcitinib is a medication being studied for its potential to help people with a skin condition called prurigo nodularis. This condition causes very itchy bumps on the skin. Povorcitinib is being tested to see if it can reduce the itchiness and improve the appearance of the skin lesions. The trial aims to determine how effective and safe this medication is for people suffering from this condition.

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 believed to be related to an overactive immune response. The condition can persist for many years, with periods of improvement and worsening.

Trial ID:
2024-511879-16-00
Protocol code:
INCB 54707-305
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • ICP-332 for Adults with Prurigo Nodularis

    Recruiting

    2 1
    Investigated Diseases:
    Austria Belgium France Germany Poland
  • Long-term safety study of oral povorcitinib in patients with hidradenitis suppurativa, prurigo nodularis, or vitiligo who previously participated in clinical trials

    Recruiting

    3 1 1
    Austria Belgium Bulgaria Czechia Denmark France +7