A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
Launched by INCYTE CORPORATION · Jul 18, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called STOP-PN2, is studying a medication called povorcitinib to see how well it works for people with prurigo nodularis, a skin condition that causes severe itching and bumps on the skin. The main goal is to find out if this treatment can help reduce itching and improve skin lesions in participants. The trial is currently looking for volunteers aged 18 to 75 who have had prurigo nodularis for at least three months and experience significant itching. Participants should have at least 20 itchy spots on their skin in different areas of the body and have not had success with other treatments.
If you are eligible and decide to join the trial, you can expect to receive treatment and be monitored throughout the study. It’s important to note that certain health conditions and recent treatments may exclude you from participating, so a thorough screening will take place. This trial is an opportunity to potentially benefit from a new treatment while 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
Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Saint Louis, Missouri, United States
Madrid, , Spain
Brooklyn, New York, United States
Madrid, , Spain
Badalona, , Spain
Detroit, Michigan, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Cincinnati, Ohio, United States
Alicante, , Spain
Muenster, , Germany
Cordoba, , Spain
Madrid, , Spain
Dresden, , Germany
Sendai, , Japan
Los Angeles, California, United States
Fort Gratiot, Michigan, United States
Dallas, Texas, United States
Barcelona, , Spain
Aachen, , Germany
Niigata, , Japan
Darmstadt, , Germany
Yardley, Pennsylvania, United States
Majadahonda, , Spain
Muenchen, , Germany
Tarnow, , Poland
Aventura, Florida, United States
Saint Joseph, Missouri, United States
Seville, , Spain
Warszawa, , Poland
Miami, Florida, United States
Darmstadt, , Germany
Oldenburg, , Germany
Manises, , Spain
Dudley, , United Kingdom
Hialeah, Florida, United States
Shinjuku Ku, , Japan
Toronto, Ontario, Canada
Frankfurt Am Main, , Germany
Buxtehude, , Germany
Murray, Utah, United States
Liege, , Belgium
Morgantown, West Virginia, United States
Louisville, Kentucky, United States
Granada, , Spain
Lodz, , Poland
Ostrowiec Swietokrzyski, , Poland
Mainz, , Germany
Phoenix, Arizona, United States
London, Ontario, Canada
Chicago, Illinois, United States
Ann Arbor, Michigan, United States
Edegem, , Belgium
Scottsdale, Arizona, United States
Frankfurt Am Main, , Germany
Murfreesboro, Tennessee, United States
Athens, Ohio, United States
Darmstadt, , Germany
Sacramento, California, United States
Warszawa, , Poland
Quebec City, Quebec, Canada
Barrie, Ontario, Canada
Scottsdale, Arizona, United States
Saskatoon, Saskatchewan, Canada
Poznan, , Poland
Oklahoma City, Oklahoma, United States
Clarkston, Michigan, United States
Westmead, New South Wales, Australia
Majadahonda, , Spain
Melbourne, Victoria, Australia
Boca Raton, Florida, United States
Hackensack, New Jersey, United States
Santa Monica, California, United States
Katowice, , Poland
Portsmouth, New Hampshire, United States
Coral Gables, Florida, United States
Witten, , Germany
Waterford, Michigan, United States
Gent, , Belgium
Gottingen, , Germany
Clarksville, Indiana, United States
Torun, , Poland
London, , United Kingdom
Badalona, , Spain
New York, New York, United States
Valdivia, , Chile
Toronto, Ontario, Canada
Rockville, Maryland, United States
Torun, , Poland
Kogarah, New South Wales, Australia
New Albany, Indiana, United States
Boynton Beach, Florida, United States
Rzeszow, , Poland
Santiago, , Chile
Fountain Valley, California, United States
Brighton, Massachusetts, United States
Liege, , Belgium
Woluwe Saint Lambert, , Belgium
Ipswich, , United Kingdom
Frankfurt Am Main, , Germany
Woluwe Saint Lambert, , Belgium
Warszawa, , Poland
Alicante, , Spain
Loverval, , Belgium
Minamikoshigaya, , Japan
Brugge, , Belgium
Fayetteville, Arkansas, United States
Dublin, Ohio, United States
Lublin, , Poland
Wroclaw, , Poland
Valencia, , Spain
Brandon, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
New York, New York, United States
Cincinnati, Ohio, United States
Seattle, Washington, United States
Newcastle, New South Wales, Australia
Sydney, New South Wales, Australia
Wolloongabba, Queensland, Australia
Fremantle, , Australia
Gent, , Belgium
Loverval, , Belgium
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Las Condes Santiago, , Chile
Prague, , Czechia
Prague, , Czechia
Chemnitz, , Germany
Magdeburg, , Germany
Gdansk, , Poland
Lodz, , Poland
Poznan, , Poland
Santiago De Compostela, , Spain
Colchester, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Poole, , United Kingdom
Redhill, , United Kingdom
Sugar Land, Texas, United States
Edegem, , Belgium
Kobe, , Japan
Harrogate, , United Kingdom
Hollywood, Florida, United States
Tamarac, Florida, United States
Bunkyo Ku, , Japan
Aachen, , Germany
Kamimashiki Gun, , Japan
Kitakyushu, , Japan
Gent, , Belgium
Inashiki Gun, , Japan
Sapporo, , Japan
Kawasaki Shi, , Japan
Ota Ku, , Japan
Sakai, , Japan
Tokorozawa Shi, , Japan
Osaka, , Japan
Osaka, , Japan
Cincinnati, Ohio, United States
Tampa, Florida, United States
Burien, Washington, United States
Kobe, , Japan
Osaka, , Japan
Hollywood, Florida, United States
Brugge, , Belgium
Praha 13 Stodulky, , Czechia
Valencia, , Spain
Patients applied
Trial Officials
Incyte Medical Monitor
Study Director
Incyte Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported