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Clinical Trials in the UK / NCT06516965
Active, not recruiting Phase 3

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

NCT06516965 · tracked via the Priya Life Science UK tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2024-10-10
Last updated
2026-04-14

Condition(s) studied

Prurigo Nodularis

Investigational drug(s) / intervention(s)

PovorcitinibPlacebo

Povorcitinib: Oral Tablet

Placebo: Oral Tablet

Study summary

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Male and female participants 18 to 75 years of age. * Clinical diagnosis of PN for at least 3 months prior to Screening visit. * 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. * Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus. * Diagnosis of PN secondary to medications. * Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit. * Women who are pregnant (or are considering pregnancy) or breastfeeding. * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies. * Evidence of infection with TB, HBV, HCV or HIV. * History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease. * Laboratory values outside of the protocol-defined ranges. Other protocol-defined Inclusion/Exclusion Criteria apply.

Primary outcome measure(s)

Trial sites (119)

FacilityCityRegionStatus
Medical Dermatology Specialists Phoenix Phoenix Arizona
Investigate Md Scottsdale Arizona
First Oc Dermatology Research Inc Fountain Valley California
Clinical Science Institute Clinical Research Specialists Inc Santa Monica California
Center For Clinical and Cosmetic Research Aventura Florida
Schweiger Dermatology Boca Raton Florida
Direct Helpers Research Center Hialeah Florida
Skin Care Research, Llc Hollywood Florida
Ziaderm Research, Llc Miami Florida
Nodal Medical Center, Llc Tampa Florida
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location Tampa Florida
Dermatology Specialists Research Louisville Kentucky
University of Maryland School of Medicine Baltimore Maryland
Dermatology Associates Pc Rockville Maryland
Metro Boston Clinical Partners Brighton Massachusetts
Fivenson Dermatology Ann Arbor Michigan
Henry Ford Health System Detroit Michigan
Michigan Dermatology Institute Waterford Michigan
Allcutis Research, Llc Portsmouth New Hampshire
Schweiger Dermatology Hackensack New Jersey
OPTISKIN New York New York
University of Cincinnati Cancer Institute Cincinnati Ohio
Central Sooner Research Oklahoma City Oklahoma
Paddington Testing Co Inc Philadelphia Pennsylvania
Yardley Dermatology Associates Yardley Pennsylvania
Modern Research Associates Pllc Dallas Texas
University of Utah Midvalley Dermatology Murray Utah
Aesthetic General Dermatology of Seattle Burien Washington
Novatrials Charlestown New South Wales
Premier Specialists Pty Ltd Kogarah New South Wales
Skin & Cancer Foundation Australia Sydney New South Wales
Westmead Hospital Westmead New South Wales
Veracity Clinical Research Pty Ltd Woolloongabba Queensland
The Alfred Hospital Melbourne Victoria
Fremantle Dermatology Fremantle Australia
Az Sint-Jan Brugge Av Bruges Belgium
Universitair Ziekenhuis Gent (Uz Gent) Ghent Belgium
Grand Hopital de Charleroi - Site Imtr Gilly Belgium
Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman Liège Belgium
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium

+ 79 more sites — see the full list on the official registry below.

More Incyte Corporation trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06516965 on ClinicalTrials.gov ↗ ← All trials in the UK