A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
Status: Recruiting
Location: See all (120) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Cahaba Dermatology
RECRUITING
Birmingham
Arkansas
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
RECRUITING
Fayetteville
Burke Pharmaceutical Research
RECRUITING
Hot Springs
Arizona
Banner - University Medicine Multispecialty Services Clinic
RECRUITING
Tucson
California
Dermatology Research Associates
RECRUITING
Los Angeles
Northridge
RECRUITING
Northridge
Florida
Rendon Center the Dermatology and Aesthetic Center
RECRUITING
Boca Raton
Driven Research Llc
RECRUITING
Coral Gables
University of Miami Miller School of Medicine
RECRUITING
Miami
Research Institute of the Southeast, Llc
RECRUITING
West Palm Beach
Illinois
Center For Medical Dermatology and Immunology Research
RECRUITING
Chicago
Chicago Cosmetic Surgery and Dermatology
COMPLETED
Chicago
Illinois Dermatology Institute the Chicago Loop
RECRUITING
Chicago
Northshore University Healthsystem
RECRUITING
Skokie
Indiana
Dermatology Specialists Research Ds Research Indiana Location
RECRUITING
Clarksville
Michigan
Oakland Hills Dermatology
RECRUITING
Auburn Hills
Hamzavi Dermatology
RECRUITING
Fort Gratiot
Somerset Skin Centre
RECRUITING
Troy
Missouri
Medisearch Clinical Trials
RECRUITING
Saint Joseph
Washington University School of Medicine
RECRUITING
St Louis
New Mexico
The University of New Mexico Unm Health Sciences Center Hsc
RECRUITING
Albuquerque
New York
Montefiore Medical Center
RECRUITING
East Syracuse
Skin Center Dermatology Group
RECRUITING
New York
Stony Brook Dermatology Associates
RECRUITING
Stony Brook
Ohio
Centricity Research Columbus
RECRUITING
Columbus
Wright State Physicians Health Center
RECRUITING
Dayton
Tennessee
International Clinical Research Tennessee Llc
RECRUITING
Murfreesboro
Texas
Dermatology Treatment and Research Center
RECRUITING
Dallas
Sweetwater Dermatology
RECRUITING
Sugar Land
Center For Clinical Studies
RECRUITING
Webster
Washington
Frontier Dermatology
RECRUITING
Mill Creek
Other Locations
Argentina
Cedic - Consultorios Medicos
RECRUITING
Buenos Aires
Conexa Investigacion Clinica S.A.
RECRUITING
Buenos Aires
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)
RECRUITING
Buenos Aires
Instituto de Neumonologia Y Dermatologia
NOT_YET_RECRUITING
Buenos Aires
Centro de Investigaciones Medicas Mar Del Plata
RECRUITING
Mar Del Plata
Instituto Especialidades de La Salud Rosario - Clinica Del Torax
RECRUITING
Rosario
Investigaciones Reumatologicas Tucuman S.R.L.
RECRUITING
San Miguel De Tucumán
Austria
Medical University Graz University Clinic For Dermatology and Venerology
RECRUITING
Graz
Wiener Krankenanstaltenverbund (Kav) - Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhuegel
RECRUITING
Vienna
Bulgaria
Medical Center Medconsult Pleven
RECRUITING
Lovech
Medconsult Pleven
RECRUITING
Pleven
Diagnostic-Consultative Centre Pulmed Eood
RECRUITING
Plovdiv
Medical Center Prolet Eood
RECRUITING
Rousse
Medical Center Unimed Eood
RECRUITING
Sevlievo
Diagnostic-Consultative Center Aleksandrovska Eood
RECRUITING
Sofia
Diagnostic-Consultative Center Ascendent Eood
RECRUITING
Sofia
Canada
Simcoderm Medical and Surgical Dermatology Centre
RECRUITING
Barrie
Dermatology Research Institute
NOT_YET_RECRUITING
Calgary
Skin Health
RECRUITING
Cobourg
Alpha Research-Lucere Dermatology and Laser Clinic
NOT_YET_RECRUITING
Edmonton
Rao Dermatology
RECRUITING
Edmonton
Skin Physicians
NOT_YET_RECRUITING
Edmonton
Centricity Research London Victoria Multispecialty
RECRUITING
London
Dermeffects
NOT_YET_RECRUITING
London
Centre de Recherche Dermatologique de Quebec
RECRUITING
Québec
Centre de Recherche Saint-Louis
NOT_YET_RECRUITING
Québec
Skinsense Medical Research
RECRUITING
Saskatoon
Park Dermatology
NOT_YET_RECRUITING
Sherwood Park
North York Research Inc.
NOT_YET_RECRUITING
Toronto
Toronto Research Centre
NOT_YET_RECRUITING
Toronto
Sima Recherche
RECRUITING
Verdun
France
Hopital Prive D Antony
RECRUITING
Antony
Hospital Morvan
RECRUITING
Brest
Cabinet Medical- Chemin de Paradis
NOT_YET_RECRUITING
Martigues
Ghrmsa Hopital Emile Muller
RECRUITING
Mulhouse
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
RECRUITING
Nantes
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital Saint-Louis
RECRUITING
Paris
Hopitaux Drome Nord - Site de Romans Sur Isere
RECRUITING
Romans-sur-isère
Hopital Larrey
RECRUITING
Toulouse
Germany
Fachklinik Bad Bentheim
RECRUITING
Bad Bentheim
Charite Universitatsmedizin Berlin
RECRUITING
Berlin
Hautzentrum Friedrichshain Studien
RECRUITING
Berlin
Klinikum Dortmund Ggmbh
RECRUITING
Dortmund
Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie
RECRUITING
Halle
Universitaetsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Universitatsklinik Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck
RECRUITING
Lübeck
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
NOT_YET_RECRUITING
Mainz
Universitaetsklinikum Giessen Und Marburg Gmbh
RECRUITING
Marburg
Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen
RECRUITING
Tübingen
Italy
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
RECRUITING
Catania
Clinical Research Centre - Cast
RECRUITING
Chieti
Presidio Ospedaliero Firenze Centro Piero Palagi
WITHDRAWN
Florence
Azienda Sanitaria Locale 1 (Asl 1) - Ospedale Regionale San Salvatore
RECRUITING
L’aquila
Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
RECRUITING
Milan
Aou Universita Della Campania Luigi Vanvitelli, Azienda Ospedaliero Universitaria Federico Ii Di Nap
RECRUITING
Napoli
Azienda Ospedaliera Di Perugia
RECRUITING
Perugia
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
RECRUITING
Pisa
Catholic University of the Sacred Heart
RECRUITING
Rome
Irccs Istituto Clinico Humanitas
RECRUITING
Rozzano
Netherlands
Amsterdam Umc Research Bv
RECRUITING
Amsterdam
Maxima Medisch Centrum
RECRUITING
Veldhoven
Poland
Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny Dermal
RECRUITING
Bialystok
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Mazowieckie Centrum Badan Klinicznych
RECRUITING
Grodzisk Mazowiecki
Gyncentrum Sp. Z O.O., Nzoz Holsamed- Oddzial Libero
RECRUITING
Katowice
Pro Familia Altera Sp. Z O.O.
RECRUITING
Katowice
Centrum Badan Klinicznych, Jagiellonskie Centrum Innowacji Sp.Z.O.O.
RECRUITING
Krakow
Diamond Clinic Sp. Z O.O.
RECRUITING
Krakow
Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser
RECRUITING
Lublin
Laser Clinic
RECRUITING
Szczecin
Centrum Medyczne Evimed
RECRUITING
Warsaw
Clinical Research Group Sp. Z.O.O
RECRUITING
Warsaw
Klinika Ambroziak Sp. Z O.O.
RECRUITING
Warsaw
Nzoz Gyncentrum - Oddzial Warszawa
RECRUITING
Warsaw
Dermaceum Centrum Badan Klinicznych
RECRUITING
Wroclaw
Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia
RECRUITING
Wroclaw
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan-si
Soon Chun Hyang University Bucheon Hospital
RECRUITING
Bucheon-si
Pusan National University Hospital (Pnuh)
RECRUITING
Busan
Pusan National University Yangsan Hospital
RECRUITING
Busan
The Catholic University of Korea, Incheon St. Mary'S Hospital
RECRUITING
Incheon
Jeonbuk National University Hospital
RECRUITING
Jeonju
Konkuk University Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Switzerland
Inselspital Bern
RECRUITING
Bern
Dsc Clinic Buochs
RECRUITING
Buochs
Universitatsspital Zurich
RECRUITING
Zurich
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2027-05-03
Participants
Target number of participants: 330
Treatments
Experimental: Povorcitinib Dose 1
Povorcitinib at the protocol-defined dose.
Experimental: Povorcitinib Dose 2
Povorcitinib at the protocol-defined dose.
Placebo_comparator: Placebo
Placebo at the protocol-defined dose.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation