A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
Status: Active_not_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
Phoenix
Investigate Md
Scottsdale
California
First Oc Dermatology Research Inc
Fountain Valley
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica
Florida
Center For Clinical and Cosmetic Research
Aventura
Schweiger Dermatology
Boca Raton
Direct Helpers Research Center
Hialeah
Skin Care Research, Llc
Hollywood
Ziaderm Research, Llc
Miami
Nodal Medical Center, Llc
Tampa
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
Tampa
Kentucky
Dermatology Specialists Research
Louisville
Massachusetts
Metro Boston Clinical Partners
Brighton
Maryland
University of Maryland School of Medicine
Baltimore
Dermatology Associates Pc
Rockville
Michigan
Fivenson Dermatology
Ann Arbor
Henry Ford Health System
Detroit
Michigan Dermatology Institute
Waterford
New Hampshire
Allcutis Research, Llc
Portsmouth
New Jersey
Schweiger Dermatology
Hackensack
New York
OPTISKIN
New York
Ohio
University of Cincinnati Cancer Institute
Cincinnati
Oklahoma
Central Sooner Research
Oklahoma City
Pennsylvania
Paddington Testing Co Inc
Philadelphia
Yardley Dermatology Associates
Yardley
Texas
Modern Research Associates Pllc
Dallas
Utah
University of Utah Midvalley Dermatology
Murray
Washington
Aesthetic General Dermatology of Seattle
Burien
Other Locations
Australia
Novatrials
Charlestown
Fremantle Dermatology
Fremantle
Premier Specialists Pty Ltd
Kogarah
The Alfred Hospital
Melbourne
Skin & Cancer Foundation Australia
Sydney
Westmead Hospital
Westmead
Veracity Clinical Research Pty Ltd
Woolloongabba
Belgium
Az Sint-Jan Brugge Av
Bruges
Universitair Ziekenhuis Gent (Uz Gent)
Ghent
Grand Hopital de Charleroi - Site Imtr
Gilly
Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman
Liège
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-saint-lambert
Canada
Simcoderm Medical and Surgical Dermatology Centre
Barrie
Alpha Research-Lucere Dermatology and Laser Clinic
Edmonton
Skin Physicians
Edmonton
Dermeffects
London
Centre de Recherche Saint-Louis
Québec
Skinsense Medical Research
Saskatoon
North York Research Inc.
Toronto
Toronto Research Centre
Toronto
Chile
Centro Internacional de Estudios Clinicos
Santiago
Centro Medico Skinmed Limitada
Santiago
Clinical Research Chile Spa.
Valdivia
Germany
University Hospital Rwth Aachen
Aachen
Elbe Kliniken Buxtehude
Buxtehude
Drk Krankenhaus Chemnitz-Rabenstein
Chemnitz
Klinikum Darmstadt
Darmstadt
Rosenpark Research Gmbh
Darmstadt
University Hospital Carl Gustav Carus
Dresden
Klinikum Der Johann Wolfgang Goethe-Universitaet
Frankfurt Am Main
Universitaetsmedizin Goettingen
Göttingen
Magdeburger Company For Medical Studies and Services Gmbh
Magdeburg
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz
Technischen Universitaet Muenchen
München
University Hospital Muenster
Münster
Klinikum Oldenburg Aor
Oldenburg
Hautarztpraxis Dr. Hoffmann
Witten
Japan
Tokyo Medical and Dental University Hospital, Faculty of Medicine
Bunkyō City
Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum
Inashiki-gun
Noguchi Dermatology Clinic
Kamimashiki-gun
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi
University of Occupational and Environmental Health, Japan
Kitakyushu
Shimizu Dermatology Clinic
Kobe
Aoi Dermatology Clinic
Kumamoto
Dokkyo Medical University Saitama Medical Center
Minamikoshigaya
Central Japan International Medical Center
Minokamo
Niigata University Medical & Dental Hospital
Niigata
Medical Corporation Jun Dermatology Clinic
Osaka
Tanpopo Dermatology Clinic
Ōta-ku
Kume Derma Clinic
Sakai
Sapporo Skin Clinic
Sapporo
Tohoku University Hospital
Sendai
Tokyo Medical University Hospital
Shinjuku-ku
National Defense Medical College Hospital
Tokorozawa
Nomura Dermatology Clinic
Yokohama
Queen'S Square Medical Facilities
Yokohama
Poland
Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy
Gdansk
Care Clinic Sp. Z O.O.
Katowice
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
Lodz
Santa Familia Ptg Lodz
Lodz
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska
Lublin
Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa
Poznan
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów
Mics Centrum Medyczne Torun
Torun
High-Med. Przychodnia Specjalistyczna
Warsaw
Panstwowy Instytut Medyczny Mswia
Warsaw
Royalderm Agnieszka Nawrocka
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska
Wroclaw
Spain
Hospital General Universitario Dr Balmis
Alicante
Hospital Universitari Germans Trias I Pujol (Hugtp)
Badalona
Hospital de La Santa Creu I Sant Pau
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital Clinico Universitario San Cecilio
Granada
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramon Y Cajal
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda
Hospital de Manises
Manises
Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag
Santiago De Compostela
Hospital Universitario Virgen Del Rocio
Seville
Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev
Valencia
United Kingdom
The Dudley Group Nhs Foundation Trust
Dudley
Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust
Ipswich
Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust
Liverpool
Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust
London
The Royal London Hospital - Barts Health Nhs Trust
London
Poole Hospital - University Hospitals Dorset Nhs Foundation Trust
Poole
Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital
Redhill
Time Frame
Start Date: 2024-10-10
Completion Date: 2027-05-03
Participants
Target number of participants: 346
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