Study on the Effects of Povorcitinib for Patients with Prurigo Nodularis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Povorcitinib on a skin condition known as Prurigo Nodularis. Prurigo Nodularis is a chronic skin disease characterized by itchy nodules or bumps on the skin. The purpose of the study is to evaluate how well Povorcitinib can reduce itchiness and improve skin lesions in individuals with this condition.

Participants in the study will be randomly assigned to receive either Povorcitinib or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The treatment will be administered in the form of tablets taken orally, and the study will last for a period of up to 48 weeks.

Throughout the study, participants will be monitored to assess the effectiveness and safety of Povorcitinib. The main goal is to see if there is a significant improvement in the itchiness and appearance of the skin lesions by the end of the study period. Participants will have regular check-ups to track their progress and any changes in their condition.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the medication povorcitinib or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

2 medication administration

You will take the assigned medication in the form of a tablet by mouth. The exact dosage and frequency will be provided by the study team. It is important to follow the instructions carefully for the duration of the study.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups will include assessments of your itch and skin condition.

4 evaluation of progress

At week 24, your progress will be evaluated to determine the effectiveness of the treatment. This will involve measuring improvements in itch and skin lesions.

5 completion of the study

Once the study is completed, you will receive information about the results and any next steps. Your participation will contribute to understanding the treatment of prurigo nodularis.

Who Can Join the Study?

  • Ability to understand and willingness to sign a written consent form for the study.
  • Age between 18 and 75 years.
  • Clinical diagnosis of Prurigo Nodularis (PN) for at least 3 months before the start of the study.
  • Pruritus, which means itching, with an average itch score of 7 or higher during the 7 days before the study starts.
  • At least 20 itchy skin bumps in total on at least 2 different body areas (such as both legs, both arms, or the trunk) at the start of the study.
  • IGA-CPG-S score of 3 or higher at the start of the study. This is a score used to measure the severity of skin conditions.
  • History of treatment failure, intolerance, or inability to use a previous treatment for PN, except for certain types of treatments called JAK or TYK2 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 with any other skin condition that might interfere with the study results.
  • Participants who have had a recent infection that required treatment with antibiotics, antivirals, or antifungals.
  • Participants who have a history of cancer, except for certain types of skin cancer that have been treated.
  • Participants who have a history of severe allergic reactions.
  • Participants who are currently using other medications that might interfere with the study treatment.
  • Participants who have a history of drug or alcohol abuse within the past year.
  • Participants who are pregnant or breastfeeding.
  • Participants who have participated in another clinical trial within the last 30 days.
  • Participants with any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Akk Medical Sp. z o.o. Gdansk Poland
Sanatorium profesora Arenbergera Prague Czechia
Universitaetsmedizin Goettingen Goettingen Germany
Royalderm Agnieszka Nawrocka Warsaw Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland

Other Sites

Site Name City Country Status
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Grand Hopital De Charleroi Charleroi Belgium
Santa Sp. z o.o. Lodz Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Rosenpark Research GmbH Darmstadt Germany
Klinikum Darmstadt GmbH Darmstadt Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Clintrial s.r.o. Prague Czechia
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Virgen del Rocío University Hospital Sevilla Spain
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen Chemnitz Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
Care Clinic Sp. z o.o. Katowice Poland
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna Warsaw Poland
Cojyzcvgy Uuyagryhrduqqg Stpndcptf Woluwe-Saint-Lambert Belgium
Mlqityptnpn Ctvheey Fic Mwxnwso Sebimly &wznx Staxtlpy Goiy Magdeburg Germany
Sifjoktf Ca sllhyf Prague Czechia
Heqccaxhqzfwjj Dp Mxz Msugzssi Hsndibxz Witten Germany
Mnarglfeh Ieogxwhugr Cloqwkyg Sjwxaoiw Srv z omxx Warsaw Poland
Ufpoeqlvxbnvfsexirlyh Maaxnxyu Alw Munster Germany
Pbcjpwyvp Iigpjgyh Mgfduhjt Mmasnusistyb Stnpu Wvtioqizgjhm I Ankkberewqwco Warsaw Poland
Gaumrv Uhyxtpbqsd Fqqyqjqff Frankfurt Germany
Hsvyrweh Dd Lb Spbfg Csoa I Sulu Pal Barcelona Spain
Ftstonomq Pcdm Lj Ipqscdxbykdct Bklwviyvi Des Hrwrffxc Uufgiviexwtwf Lt Pma Madrid Spain
Hzqaeyxz Uigzcsssqxlcg Hzzwcsho Tlmfv y Pexecd Iknubtwp Cayguu diwhksnwrfvdhpowd (xwib Badalona Spain
Lcvdzyh Sppjbbuozistqov Guztzqi Dgtoeavsifpcpqj Lublin Poland
Dinvgpbifvcx Qabki Mainz Germany

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
10.12.2024
Czechia Czechia
Not recruiting
10.12.2024
Germany Germany
Not recruiting
10.12.2024
Poland Poland
Not recruiting
10.12.2024
Spain Spain
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.

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:
2024-511881-35-00
Protocol code:
INCB 54707-306
Trial Phase:
Therapeutic confirmatory (Phase III)

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