Not recruiting

Study on the Effects of Povorcitinib for Patients with Prurigo Nodularis

Fast replyInvestigationalNo placebo

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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, 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

9 criteria

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 trial?

8 criteria

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.

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Diamond Clinic Sp. z o.o.
Cracow, Poland
Not recruiting
Responsive
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Chieti, Italy

Trial locations

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Investigated drugs

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.

4-[3-(Cyanomethyl)-3-(3',5'-Dimethyl-1H,1'H-[4,4'-Bipyrazol]-1-Yl)Azetidin-1-Yl]-2,5-Difluoro-N-[(2S)-1,1,1-Trifluoropropan-2-Yl]Benzamide

What is already known about the treatment

Povorcitinib – Povorcitinib is administered orally in the form of tablets. It is currently being studied in a Phase 3 clinical trial to assess its effectiveness and safety for treating Prurigo Nodularis, a skin condition characterized by intensely itchy nodules. The main goal of the trial is to determine how well povorcitinib can reduce itchiness and improve skin lesions in affected individuals. At the molecular level, povorcitinib works by inhibiting certain enzymes involved in the inflammatory process, which helps to alleviate symptoms. It is classified pharmacologically as a Janus kinase (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 believed to be related to an overactive immune response. The condition can persist for many years, with periods of improvement and worsening.