A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
Status: Recruiting
Location: See all (116) 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
Arizona
Medical Dermatology Specialists Phoenix
RECRUITING
Phoenix
Investigate Md
RECRUITING
Scottsdale
California
First Oc Dermatology Research Inc
RECRUITING
Fountain Valley
Clinical Science Institute Clinical Research Specialists Inc
RECRUITING
Santa Monica
Florida
Center For Clinical and Cosmetic Research
RECRUITING
Aventura
Clearlyderm Dermatology
RECRUITING
Boca Raton
Direct Helpers Research Center
RECRUITING
Hialeah
Skin Care Research, Llc
RECRUITING
Hollywood
Ziaderm Research, Llc
RECRUITING
Miami
Nodal Medical Center, Llc
RECRUITING
Tampa
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
RECRUITING
Tampa
Kentucky
Dermatology Specialists Research
RECRUITING
Louisville
Massachusetts
Metro Boston Clinical Partners
RECRUITING
Brighton
Maryland
University of Maryland School of Medicine
RECRUITING
Baltimore
Dermatology Associates Pc
RECRUITING
Rockville
Michigan
Fivenson Dermatology
RECRUITING
Ann Arbor
Henry Ford Health System
RECRUITING
Detroit
Michigan Dermatology Institute
RECRUITING
Waterford
New Hampshire
Allcutis Research, Llc
COMPLETED
Portsmouth
New Jersey
Schweiger Dermatology
RECRUITING
Hackensack
New York
OPTISKIN
RECRUITING
New York
Ohio
University of Cincinnati Cancer Institute
RECRUITING
Cincinnati
Oklahoma
Central Sooner Research
RECRUITING
Oklahoma City
Pennsylvania
Paddington Testing Co Inc
RECRUITING
Philadelphia
Yardley Dermatology Associates
RECRUITING
Yardley
Texas
Modern Research Associates Pllc
COMPLETED
Dallas
Utah
University of Utah Midvalley Dermatology
RECRUITING
Murray
Washington
Aesthetic General Dermatology of Seattle
RECRUITING
Burien
Other Locations
Australia
Fremantle Dermatology
RECRUITING
Fremantle
Premier Specialists Pty Ltd
RECRUITING
Kogarah
The Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Novatrials
RECRUITING
Newcastle
Skin & Cancer Foundation Australia
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Westmead
Veracity Clinical Research Pty Ltd
RECRUITING
Wolloongabba
Belgium
Az Sint-Jan Brugge Av
RECRUITING
Bruges
Universitair Ziekenhuis Gent (Uz Gent)
RECRUITING
Ghent
Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman
RECRUITING
Liège
Grand Hopital de Charleroi - Site Imtr
RECRUITING
Loverval
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
RECRUITING
Woluwe-saint-lambert
Canada
Simcoderm Medical and Surgical Dermatology Centre
RECRUITING
Barrie
Alpha Research-Lucere Dermatology and Laser Clinic
RECRUITING
Edmonton
Skin Physicians
RECRUITING
Edmonton
Dermeffects
RECRUITING
London
Centre de Recherche Saint-Louis
RECRUITING
Québec
Skinsense Medical Research
RECRUITING
Saskatoon
North York Research Inc.
RECRUITING
Toronto
Toronto Research Centre
RECRUITING
Toronto
Chile
Centro Medico Skinmed Limitada
RECRUITING
Las Condes Santiago
Centro Internacional de Estudios Clinicos
RECRUITING
Santiago
Clinical Research Chile Spa.
RECRUITING
Valdivia
Germany
University Hospital Rwth Aachen
RECRUITING
Aachen
Elbe Kliniken Buxtehude
RECRUITING
Buxtehude
Drk Krankenhaus Chemnitz-Rabenstein
RECRUITING
Chemnitz
Klinikum Darmstadt
RECRUITING
Darmstadt
Rosenpark Research Gmbh
RECRUITING
Darmstadt
University Hospital Carl Gustav Carus
RECRUITING
Dresden
Klinikum Der Johann Wolfgang Goethe-Universitaet
RECRUITING
Frankfurt Am Main
Universitaetsmedizin Goettingen
RECRUITING
Göttingen
Magdeburger Company For Medical Studies and Services Gmbh
RECRUITING
Magdeburg
Dermatologische Gemeinschaftspraxis Dres. Quist
RECRUITING
Mainz
Technischen Universitaet Muenchen
RECRUITING
München
University Hospital Muenster
RECRUITING
Münster
Klinikum Oldenburg Aor
RECRUITING
Oldenburg
Hautarztpraxis Dr. Hoffmann
RECRUITING
Witten
Japan
Tokyo Medical and Dental University Hospital, Faculty of Medicine
RECRUITING
Bunkyō City
Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum
RECRUITING
Inashiki-gun
Noguchi Dermatology Clinic
RECRUITING
Kamimashiki-gun
Nippon Medical School Musashikosugi Hospital
RECRUITING
Kawasaki-shi
University of Occupational and Environmental Health, Japan
RECRUITING
Kitakyushu
Shimizu Dermatology Clinic
RECRUITING
Kobe
Dokkyo Medical University Saitama Medical Center
RECRUITING
Minamikoshigaya
Central Japan International Medical Center
NOT_YET_RECRUITING
Minokamo
Niigata University Medical & Dental Hospital
RECRUITING
Niigata
Medical Corporation Jun Dermatology Clinic
RECRUITING
Osaka
Tanpopo Dermatology Clinic
RECRUITING
Ōta-ku
Kume Derma Clinic
RECRUITING
Sakai
Sapporo Skin Clinic
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
National Defence Medical College Hospital
RECRUITING
Tokorozawa-shi
Nomura Dermatology Clinic
NOT_YET_RECRUITING
Yokohama
Queen'S Square Medical Facilities
NOT_YET_RECRUITING
Yokohama
Poland
Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy
RECRUITING
Gdansk
Care Clinic Sp. Z O.O.
RECRUITING
Katowice
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
RECRUITING
Lodz
Santa Familia Ptg Lodz
RECRUITING
Lodz
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
RECRUITING
Lublin
Dermedic Jacek Zdybski
NOT_YET_RECRUITING
Ostrowiec Świętokrzyski
Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa
RECRUITING
Poznan
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
RECRUITING
Rzeszów
Mics Centrum Medyczne Toruń
RECRUITING
Torun
High-Med. Przychodnia Specjalistyczna
RECRUITING
Warsaw
Panstwowy Instytut Medyczny Mswia
RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
RECRUITING
Wroclaw
Spain
Hospital General Universitario Dr Balmis
RECRUITING
Alicante
Hospital Universitari Germans Trias I Pujol
RECRUITING
Badalona
Hospital de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Clinico Universitario San Cecilio
RECRUITING
Granada
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Ramon Y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
RECRUITING
Majadahonda
Hospital de Manises
RECRUITING
Manises
Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe
RECRUITING
Valencia
United Kingdom
The Dudley Group Nhs Foundation Trust
RECRUITING
Dudley
Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
RECRUITING
Ipswich
Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust
RECRUITING
Liverpool
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
RECRUITING
London
The Royal London Hospital - Barts Health Nhs Trust
RECRUITING
London
Poole Hospital - University Hospitals Dorset Nhs Foundation Trust
RECRUITING
Poole
Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital
RECRUITING
Redhill
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