A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
NCT ID: NCT06516965
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
330 participants
INTERVENTIONAL
2024-10-10
2027-05-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Povorcitinib Dose 1
Povorcitinib at the protocol-defined dose.
Povorcitinib
Oral Tablet
Povorcitinib Dose 2
Povorcitinib at the protocol-defined dose.
Povorcitinib
Oral Tablet
Placebo
Placebo at the protocol-defined dose.
Placebo
Oral Tablet
Interventions
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Povorcitinib
Oral Tablet
Placebo
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Sanatorium Profesora Arenbergera
Prague, , Czechia
Sanixtra Prague
Prague, , Czechia
University Hospital Rwth Aachen
Aachen, , Germany
Elbe Kliniken Buxtehude
Buxtehude, , Germany
Drk Krankenhaus Chemnitz-Rabenstein
Chemnitz, , Germany
Klinikum Darmstadt
Darmstadt, , Germany
Rosenpark Research Gmbh
Darmstadt, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Klinikum Der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, , Germany
Universitaetsmedizin Goettingen
Göttingen, , Germany
Magdeburger Company For Medical Studies and Services Gmbh
Magdeburg, , Germany
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States
Investigate Md
Scottsdale, Arizona, United States
First Oc Dermatology Research Inc
Fountain Valley, California, United States
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, United States
Center For Clinical and Cosmetic Research
Aventura, Florida, United States
Clearlyderm Dermatology
Boca Raton, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Skin Care Research, Llc
Hollywood, Florida, United States
Ziaderm Research, Llc
Miami, Florida, United States
Nodal Medical Center, Llc
Tampa, Florida, United States
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
Tampa, Florida, United States
Dermatology Specialists Research
Louisville, Kentucky, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Dermatology Associates Pc
Rockville, Maryland, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
Fivenson Dermatology
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Michigan Dermatology Institute
Waterford, Michigan, United States
Allcutis Research, Llc
Portsmouth, New Hampshire, United States
Schweiger Dermatology
Hackensack, New Jersey, United States
OPTISKIN
New York, New York, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Central Sooner Research
Oklahoma City, Oklahoma, United States
Paddington Testing Co Inc
Philadelphia, Pennsylvania, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, United States
Modern Research Associates Pllc
Dallas, Texas, United States
University of Utah Midvalley Dermatology
Murray, Utah, United States
Aesthetic General Dermatology of Seattle
Burien, Washington, United States
Premier Specialists Pty Ltd
Kogarah, New South Wales, Australia
Novatrials
Newcastle, New South Wales, Australia
Skin & Cancer Foundation Australia
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fremantle Dermatology
Fremantle, , Australia
Az Sint-Jan Brugge Av
Bruges, , Belgium
Universitair Ziekenhuis Gent (Uz Gent)
Ghent, , Belgium
Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman
Liège, , Belgium
Grand Hopital de Charleroi - Site Imtr
Loverval, , Belgium
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, , Belgium
Skin Physicians
Edmonton, Alberta, Canada
Alpha Research-Lucere Dermatology and Laser Clinic
Edmonton, Alberta, Canada
Simcoderm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Dermeffects
London, Ontario, Canada
North York Research Inc.
Toronto, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Centro Medico Skinmed Limitada
Santiago, , Chile
Centro Internacional de Estudios Clinicos
Santiago, , Chile
Clinical Research Chile Spa.
Valdivia, , Chile
Clintrial S.R.O.
Prague, , Czechia
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, , Germany
Technischen Universitaet Muenchen
München, , Germany
University Hospital Muenster
Münster, , Germany
Klinikum Oldenburg Aor
Oldenburg, , Germany
Hautarztpraxis Dr. Hoffmann
Witten, , Germany
Tokyo Medical and Dental University Hospital, Faculty of Medicine
Bunkyō City, , Japan
Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum
Inashiki-gun, , Japan
Noguchi Dermatology Clinic
Kamimashiki-gun, , Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi, , Japan
University of Occupational and Environmental Health, Japan
Kitakyushu, , Japan
Shimizu Dermatology Clinic
Kobe, , Japan
Aoi Skin Clinic
Kumamoto, , Japan
Dokkyo Medical University Saitama Medical Center
Minamikoshigaya, , Japan
Central Japan International Medical Center
Minokamo, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Medical Corporation Jun Dermatology Clinic
Osaka, , Japan
Tanpopo Dermatology Clinic
Ōta-ku, , Japan
Kume Derma Clinic
Sakai, , Japan
Sapporo Skin Clinic
Sapporo, , Japan
Tohoku University Hospital
Sendai, , Japan
Tokyo Medical University Hospital
Shinjuku-ku, , Japan
National Defence Medical College Hospital
Tokorozawa-shi, , Japan
Queen'S Square Medical Facilities
Yokohama, , Japan
Nomura Dermatology Clinic
Yokohama, , Japan
Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy
Gdansk, , Poland
Care Clinic Sp. Z O.O.
Katowice, , Poland
Santa Familia Ptg Lodz
Lodz, , Poland
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, , Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
Lublin, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa
Poznan, , Poland
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów, , Poland
Mics Centrum Medyczne Toruń
Torun, , Poland
High-Med. Przychodnia Specjalistyczna
Warsaw, , Poland
Panstwowy Instytut Medyczny Mswia
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
Wroclaw, , Poland
Hospital General Universitario Dr Balmis
Alicante, , Spain
Hospital Universitari Germans Trias I Pujol
Badalona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Clinico Universitario San Cecilio
Granada, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, , Spain
Hospital de Manis
Manises, , Spain
Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag
Santiago de Compostela, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe
Valencia, , Spain
The Dudley Group Nhs Foundation Trust
Dudley, , United Kingdom
Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
Ipswich, , United Kingdom
Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust
Liverpool, , United Kingdom
The Royal London Hospital - Barts Health Nhs Trust
London, , United Kingdom
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London, , United Kingdom
Poole Hospital - University Hospitals Dorset Nhs Foundation Trust
Poole, , United Kingdom
Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital
Redhill, , United Kingdom
Countries
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Central Contacts
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Related Links
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A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
Other Identifiers
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2024-511881-35-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB54707-306
Identifier Type: -
Identifier Source: org_study_id