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Tyrosine Kinase Inhibitor
Povorcitinib for Prurigo Nodularis (STOP-PN1 Trial)
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
Pivotal Trial
Summary
This trial aims to see if povorcitinib can help reduce itching and skin rashes in people with prurigo nodularis.
Who is the study for?
This trial is for adults aged 18-75 with Prurigo Nodularis, a skin condition causing itchy bumps. Participants must have had the condition and related itching for at least 3 months, with at least 20 lesions across two body areas. 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 itchiness and skin lesions in Prurigo Nodularis patients compared to a placebo (a substance with no active drug). It aims to determine if Povorcitinib can improve symptoms better than an inactive treatment.
What are the potential side effects?
Possible side effects of Povorcitinib may include reactions at the medication application site, general discomforts like headaches or nausea, potential impacts on liver function, and increased susceptibility to infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe itching for the past week.
Select...
I have 20 or more itchy spots on at least 2 different parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
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 moreAwards & 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
393 Previous Clinical Trials
63,636 Total Patients Enrolled
4 Trials studying Prurigo Nodularis
680 Patients Enrolled for Prurigo Nodularis
Incyte Medical MonitorStudy DirectorIncyte Corporation
34 Previous Clinical Trials
11,939 Total Patients Enrolled
2 Trials studying Prurigo Nodularis
354 Patients Enrolled for Prurigo Nodularis