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Tyrosine Kinase Inhibitor

Povorcitinib for Prurigo Nodularis

Phase 3
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline
Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline
Must not have
Diagnosis of PN secondary to medications
Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
Pivotal Trial

Summary

This trial aims to see how effective povorcitinib is in reducing itching and skin lesions in people with prurigo nodularis.

Who is the study for?
This trial is for adults aged 18-75 with prurigo nodularis, experiencing severe itchiness. Participants must have had the condition for at least 3 months, with a minimum of 20 itchy skin lesions across two body regions. They should have tried other treatments without success or cannot use them due to intolerance or contraindications.
What is being tested?
The study tests povorcitinib's effectiveness on reducing itch and healing skin lesions in prurigo nodularis patients compared to a placebo. Povorcitinib is an experimental medication given to see if it can provide relief where other treatments haven't worked.
What are the potential side effects?
While specific side effects are not listed here, common reactions may include irritation at the site of application, potential allergic reactions, general discomfort or worsening of symptoms initially as the body adjusts to treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had severe itching, scoring 7 or more, in the past week.
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I have 20 or more itchy spots on at least 2 different parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My nerve pain is caused by medication.
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I have had active atopic dermatitis symptoms, not just dry skin, in the last 3 months.
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I have tried JAK or TYK2 inhibitors for PN or inflammation without success.
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I am currently pregnant, considering pregnancy, or breastfeeding.
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I have long-term itching not caused by nerve or psychological conditions.
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I have a history of blood, heart, infection, or cancer-related health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24
Secondary study objectives
Change from baseline in Dermatology Life Quality Index (DLQI) score at each postbaseline visit.
Change from baseline in EQ-5D-5L score at each postbaseline visit
Change from baseline in Itch NRS score at each postbaseline visit
+21 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Povorcitinib Dose 2Experimental Treatment1 Intervention
Povorcitinib at the protocol-defined dose.
Group II: Povorcitinib Dose 1Experimental Treatment1 Intervention
Povorcitinib at the protocol-defined dose.
Group III: PlaceboPlacebo Group1 Intervention
Placebo at the protocol-defined dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Povorcitinib
2024
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
388 Previous Clinical Trials
63,305 Total Patients Enrolled
4 Trials studying Prurigo Nodularis
680 Patients Enrolled for Prurigo Nodularis
Incyte Medical MonitorStudy DirectorIncyte Corporation
33 Previous Clinical Trials
11,723 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
354 Patients Enrolled for Prurigo Nodularis
~220 spots leftby Sep 2026
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