A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
NCT ID: NCT06516952
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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Cahaba Dermatology
Birmingham, Alabama, United States
Banner - University Medicine Multispecialty Services Clinic
Tucson, Arizona, United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Dermatology Research Associates
Los Angeles, California, United States
Northridge
Northridge, California, United States
Rendon Center the Dermatology and Aesthetic Center
Boca Raton, Florida, United States
Driven Research Llc
Coral Gables, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Research Institute of the Southeast, Llc
West Palm Beach, Florida, United States
Illinois Dermatology Institute the Chicago Loop
Chicago, Illinois, United States
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, United States
Center For Medical Dermatology and Immunology Research
Chicago, Illinois, United States
Northshore University Healthsystem
Skokie, Illinois, United States
Dermatology Specialists Research Ds Research Indiana Location
Clarksville, Indiana, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
The University of New Mexico Unm Health Sciences Center Hsc
Albuquerque, New Mexico, United States
Montefiore Medical Center
East Syracuse, New York, United States
Skin Center Dermatology Group
New York, New York, United States
Stony Brook Dermatology Associates
Stony Brook, New York, United States
Centricity Research Columbus
Columbus, Ohio, United States
Wright State Physicians Health Center
Dayton, Ohio, United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Sweetwater Dermatology
Sugar Land, Texas, United States
Center For Clinical Studies
Webster, Texas, United States
Frontier Dermatology
Mill Creek, Washington, United States
Conexa Investigacion Clinica S.A.
Buenos Aires, , Argentina
Cedic - Consultorios Medicos
Buenos Aires, , Argentina
Instituto de Neumonologia Y Dermatologia
Buenos Aires, , Argentina
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)
Buenos Aires, , Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Instituto Especialidades de La Salud Rosario - Clinica Del Torax
Rosario, , Argentina
Investigaciones Reumatologicas Tucuman S.R.L.
San Miguel de Tucumán, , Argentina
Medical University Graz University Clinic For Dermatology and Venerology
Graz, , Austria
Wiener Krankenanstaltenverbund (Kav) - Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhuegel
Vienna, , Austria
Medical Center Medconsult Pleven
Lovech, , Bulgaria
Medconsult Pleven
Pleven, , Bulgaria
Diagnostic-Consultative Centre Pulmed Eood
Plovdiv, , Bulgaria
Medical Center Prolet Eood
Rousse, , Bulgaria
Medical Center Unimed Eood
Sevlievo, , Bulgaria
Diagnostic-Consultative Center Ascendent Eood
Sofia, , Bulgaria
Diagnostic-Consultative Center Aleksandrovska Eood
Sofia, , Bulgaria
Dermatology Research Institute
Calgary, Alberta, Canada
Rao Dermatology
Edmonton, Alberta, Canada
Skin Physicians
Edmonton, Alberta, Canada
Alpha Research-Lucere Dermatology and Laser Clinic
Edmonton, Alberta, Canada
Park Dermatology
Sherwood Park, Alberta, Canada
Simcoderm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Skin Health
Cobourg, Ontario, Canada
Centricity Research London Victoria Multispecialty
London, Ontario, Canada
Dermeffects
London, Ontario, Canada
North York Research Inc.
Toronto, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
Centre de Recherche Dermatologique de Quebec
Québec, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Sima Recherche
Verdun, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Hopital Prive D Antony
Antony, , France
Hospital Morvan
Brest, , France
Cabinet Medical- Chemin de Paradis
Martigues, , France
Ghrmsa Hopital Emile Muller
Mulhouse, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
Nantes, , France
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital Saint-Louis
Paris, , France
Hopitaux Drome Nord - Site de Romans Sur Isere
Romans-sur-Isère, , France
Hopital Larrey
Toulouse, , France
Aachen University Hospital
Aachen, , Germany
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Hautzentrum Friedrichshain Studien
Berlin, , Germany
Charite Universitatsmedizin Berlin
Berlin, , Germany
Klinikum Dortmund Ggmbh
Dortmund, , Germany
Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie
Halle, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitatsklinik Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
Lübeck, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Universitaetsklinikum Giessen Und Marburg Gmbh
Marburg, , Germany
Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
Tübingen, , Germany
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
Catania, , Italy
Clinical Research Centre - Cast
Chieti, , Italy
Azienda Sanitaria Locale 1 (Asl 1) - Ospedale Regionale San Salvatore
L’Aquila, , Italy
Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
Milan, , Italy
Aou Universita Della Campania Luigi Vanvitelli, Azienda Ospedaliero Universitaria Federico Ii Di Nap
Napoli, , Italy
Azienda Ospedaliera Di Perugia
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
Pisa, , Italy
Catholic University of the Sacred Heart
Rome, , Italy
Irccs Istituto Clinico Humanitas
Rozzano, , Italy
Amsterdam Umc Research Bv
Amsterdam, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny Dermal
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Mazowieckie Centrum Badan Klinicznych
Grodzisk Mazowiecki, , Poland
Gyncentrum Sp. Z O.O., Nzoz Holsamed- Oddzial Libero
Katowice, , Poland
Pro Familia Altera Sp. Z O.O.
Katowice, , Poland
Centrum Badan Klinicznych, Jagiellonskie Centrum Innowacji Sp.Z.O.O.
Krakow, , Poland
Diamond Clinic Sp. Z O.O.
Krakow, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser
Lublin, , Poland
Laser Clinic
Szczecin, , Poland
Nzoz Gyncentrum - Oddzial Warszawa
Warsaw, , Poland
Clinical Research Group Sp. Z.O.O
Warsaw, , Poland
Centrum Medyczne Evimed
Warsaw, , Poland
Klinika Ambroziak Sp. Z O.O.
Warsaw, , Poland
Dermaceum Centrum Badan Klinicznych
Wroclaw, , Poland
Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
Wroclaw, , Poland
Korea University Ansan Hospital
Ansan-si, , South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, , South Korea
Pusan National University Hospital (Pnuh)
Busan, , South Korea
Pusan National University Yangsan Hospital
Busan, , South Korea
The Catholic University of Korea, Incheon St. Mary'S Hospital
Incheon, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Inselspital Bern
Bern, , Switzerland
Dsc Clinic Buochs
Buochs, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
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-PN1)
Other Identifiers
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2024-511879-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB54707-305
Identifier Type: -
Identifier Source: org_study_id