RecruitingPhase 3NCT06516965

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis


Sponsor

Incyte Corporation

Enrollment

330 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called povorcitinib (a JAK1 inhibitor pill) in people with prurigo nodularis (PN) — a skin condition causing intensely itchy bumps (nodules) all over the body that can be very hard to treat. This is a Phase 3 study looking at whether the drug safely reduces itch and lesions. **You may be eligible if...** - You are 18–75 years old - You have had a clinical diagnosis of prurigo nodularis for at least 3 months - Your itch is severe (average score of 7 or higher on a 0–10 scale over the past week) - You have 20 or more nodules on at least 2 different body areas - Previous PN treatments have either failed, been not tolerated, or are contraindicated for you - You are willing to use contraception to prevent pregnancy **You may NOT be eligible if...** - Your chronic itch is caused by a different underlying condition - You have certain serious infections, liver problems, or immune system conditions that would make JAK inhibitors unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPovorcitinib

Oral Tablet

DRUGPlacebo

Oral Tablet


Locations(119)

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

Schweiger 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

Novatrials

Charlestown, New South Wales, Australia

Premier Specialists Pty Ltd

Kogarah, 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

Grand Hopital de Charleroi - Site Imtr

Gilly, Belgium

Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman

Liège, 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 Centre

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

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

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 Dermatology 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 Defense Medical College Hospital

Tokorozawa, 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

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 Torun

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 (Hugtp)

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 Manises

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

Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev

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

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NCT06516965


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