A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
Launched by INCYTE CORPORATION · Jul 18, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called povorcitinib to see how well it helps people with prurigo nodularis, a condition that causes intense itching and skin bumps. The main goal is to find out if this treatment can reduce itchiness and improve skin lesions in participants. The trial is currently recruiting people between the ages of 18 and 75 who have been diagnosed with prurigo nodularis for at least three months and have been experiencing significant itching, with a score of 7 or higher on a simple itch scale.
Eligible participants will have at least 20 itchy lesions on their skin and must have tried other treatments for this condition without success. It’s important for participants to understand that they need to avoid pregnancy during the study and that some individuals with certain health conditions or who are pregnant or breastfeeding cannot take part. If you choose to join this trial, you can expect to receive monitoring and care throughout the study, and you’ll be contributing to important research that could help others with prurigo nodularis in the future.
Gender
ALL
Eligibility criteria
- 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.
About Incyte Corporation
Incyte Corporation is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for oncology and other serious diseases. With a commitment to advancing precision medicine, Incyte leverages its expertise in molecular biology and clinical research to develop targeted treatments that address unmet medical needs. The company is dedicated to improving patient outcomes through rigorous clinical trials and collaborations with healthcare professionals and research institutions. Incyte's robust pipeline includes a range of investigational therapies aimed at various cancers, showcasing its dedication to transforming the landscape of cancer treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saint Louis, Missouri, United States
Troy, Michigan, United States
Hot Springs, Arkansas, United States
Heidelberg, , Germany
Leipzig, , Germany
Bad Bentheim, , Germany
Hamburg, , Germany
Seoul, , Korea, Republic Of
Los Angeles, California, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Webster, Texas, United States
Fort Gratiot, Michigan, United States
Gdansk, , Poland
Dortmund, , Germany
Aachen, , Germany
Grodzisk Mazowiecki, , Poland
Rome, , Italy
Skokie, Illinois, United States
Dallas, Texas, United States
Bari, , Italy
Houston, Texas, United States
Surrey, British Columbia, Canada
Halle, , Germany
Rozzano, , Italy
Saint Joseph, Missouri, United States
Bucheon Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Warszawa, , Poland
Miami, Florida, United States
Veldhoven, , Netherlands
West Palm Beach, Florida, United States
Incheon, , Korea, Republic Of
Zurich, , Switzerland
Ansan Si, , Korea, Republic Of
Liege, , Belgium
Mainz, , Germany
Katowice, , Poland
Catania, , Italy
Ostrowiec Swietokrzyski, , Poland
Berlin, , Germany
Warszawa, , Poland
Perugia, , Italy
Dayton, Ohio, United States
Firenze, , Italy
London, Ontario, Canada
Chicago, Illinois, United States
Lublin, , Poland
Birmingham, Alabama, United States
Murfreesboro, Tennessee, United States
Stony Brook, New York, United States
Athens, Ohio, United States
Auburn Hills, Michigan, United States
Cobourg, Ontario, Canada
Nantes, , France
Quebec City, Quebec, Canada
Barrie, Ontario, Canada
Mar Del Plata, , Argentina
Saskatoon, Saskatchewan, Canada
Anderson, South Carolina, United States
Firenze, , Italy
Sevlievo, , Bulgaria
Amsterdam, , Netherlands
Verdun, Quebec, Canada
Yangsan Si, , Korea, Republic Of
Edmonton, Alberta, Canada
Marburg, , Germany
Amsterdam, , Netherlands
Jeonju Si, , Korea, Republic Of
Clarksville, Indiana, United States
Seoul, , Korea, Republic Of
Coral Gables, Florida, United States
Mill Creek, Washington, United States
Gent, , Belgium
Gottingen, , Germany
Torun, , Poland
Berlin, , Germany
Toronto, Ontario, Canada
Pittsburgh, Pennsylvania, United States
Gent, , Belgium
Warszawa, , Poland
Ruse, , Bulgaria
Antony, , France
Liege, , Belgium
Woluwe Saint Lambert, , Belgium
Quebec City, Quebec, Canada
Brest, , France
Martigues, , France
Catania, , Italy
Szczecin, , Poland
Warsaw, , Poland
Mainz, , Germany
Woluwe Saint Lambert, , Belgium
Warszawa, , Poland
Busan, , Korea, Republic Of
Wrocaw, , Poland
L'aquila, , Italy
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Northridge, California, United States
Boca Raton, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Metairie, Louisiana, United States
Albuquerque, New Mexico, United States
East Syracuse, New York, United States
New York, New York, United States
Dublin, Ohio, United States
Sugar Land, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Rosario, , Argentina
San Miguel De Tucuman, , Argentina
Graz, , Austria
Wien, , Austria
Lovech, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
London, Ontario, Canada
Mulhouse, , France
Paris, , France
Romans Sur Isere, , France
Toulouse, , France
Bonn, , Germany
Luebeck, , Germany
Tuebingen, , Germany
Bari, , Italy
Chieti, , Italy
Milano, , Italy
Pisa, , Italy
Seongnam Si, , Korea, Republic Of
Bialystok, , Poland
Cracov, , Poland
Katowice, , Poland
Lublin, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Valencia, , Spain
Basel, , Switzerland
Bern, , Switzerland
Buochs, , Switzerland
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Bramsche, , Germany
Baton Rouge, Louisiana, United States
Camp Hill, Pennsylvania, United States
Mill Creek, Washington, United States
Aachen, , Germany
Napoli, , Italy
Perugia, , Italy
Naples, , Italy
Ciudad Autonoma De Buenos Aires, , Argentina
Kraków, , Poland
Amsterdam, , Netherlands
Lovech, , Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Brest, , France
Napoli, , Italy
Wien, , Austria
Krakow, , Poland
Patients applied
Trial Officials
Incyte Medical Monitor
Study Director
Incyte Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported