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

Last updated: November 22, 2024
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Warts

Eczema (Atopic Dermatitis)

Atopic Dermatitis

Treatment

Placebo

Povorcitinib

Clinical Study ID

NCT06516965
INCB54707-306
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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/orboth arms, and/or trunk) at Screening and Day 1/Baseline.

  • Documented history of treatment failure, demonstrated intolerance, orcontraindication to a previous PN treatment.

  • Willingness to avoid pregnancy or fathering children.

Exclusion

Exclusion Criteria:

  • Chronic pruritus due to a condition other than PN or neuropathic and psychogenicpruritus.

  • Diagnosis of PN secondary to medications.

  • Active AD lesions (signs and symptoms other than dry skin) within 3 months prior toScreening 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 ofPN or any inflammatory disease.

  • Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria apply.

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 10, 2024
Estimated Completion Date:
June 02, 2027

Connect with a study center

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales 02217
    Australia

    Site Not Available

  • Novatrials

    Newcastle, New South Wales 02289
    Australia

    Site Not Available

  • Skin & Cancer Foundation Australia

    Sydney, New South Wales 02010
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 02145
    Australia

    Site Not Available

  • Veracity Clinical Research Pty Ltd

    Wolloongabba, Queensland 04102
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 03004
    Australia

    Site Not Available

  • Fremantle Dermatology

    Fremantle, 06160
    Australia

    Site Not Available

  • Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan

    Brugge, 08000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem, 02650
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen (Uza)

    Edegem, 02650
    Belgium

    Site Not Available

  • Az Sint Lucas Gent-Campus Sint Lucas

    Gent, 09000
    Belgium

    Site Not Available

  • UZ GENT

    Gent, 09000
    Belgium

    Site Not Available

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

    Liege, 04000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 04000
    Belgium

    Site Not Available

  • Grand Hopital de Charleroi

    Loverval, 06280
    Belgium

    Site Not Available

  • Grand Hopital de Charleroi ¿ Site Imtr

    Loverval, 06280
    Belgium

    Site Not Available

  • Cliniques Universitaires Ucl Saint-Luc

    Woluwe-saint-lambert, 01200
    Belgium

    Site Not Available

  • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

    Woluwe-saint-lambert, 01200
    Belgium

    Site Not Available

  • Alpha Research-Lucere Dermatology and Laser Clinic

    Edmonton, Alberta T6X 0N9
    Canada

    Site Not Available

  • Skin Physicians

    Edmonton, Alberta T6W 4V4
    Canada

    Site Not Available

  • Simcoderm Medical and Surgical Dermatology Centre

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Dermeffects

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • North York Research Inc.

    Toronto, Ontario M2N 3A6
    Canada

    Site Not Available

  • Toronto Research Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec City, Quebec G1W 4R4
    Canada

    Site Not Available

  • Skinsense Medical Research

    Saskatoon, Saskatchewan S7K 2C1
    Canada

    Site Not Available

  • Centro Medico Skinmed Limitada

    LAS Condes Santiago, 7580206
    Chile

    Site Not Available

  • Centro Internacional de Estudios Clinicos

    Santiago, 8420383
    Chile

    Site Not Available

  • Clinical Research Chile Spa.

    Valdivia, 5090000
    Chile

    Site Not Available

  • Clintrial S.R.O.

    Prague, 100 00
    Czechia

    Site Not Available

  • Sanatorium Profesora Arenbergera

    Prague, 110 00
    Czechia

    Site Not Available

  • Aachen University Hospital

    Aachen, 52074
    Germany

    Site Not Available

  • University Hospital Rwth Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Elbe Kliniken Buxtehude

    Buxtehude, 21614
    Germany

    Site Not Available

  • Drk Krankenhaus Chemnitz-Rabenstein

    Chemnitz, 09117
    Germany

    Site Not Available

  • Klinikum Darmstadt

    Darmstadt, 64283
    Germany

    Site Not Available

  • Rosenpark Research

    Darmstadt, 64283
    Germany

    Site Not Available

  • University Hospital Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Klinikum Der Johann Wolfgang Goethe University

    Frankfurt Am Main, 60590
    Germany

    Site Not Available

  • Klinikum Der Johann Wolfgang Goethe-Universitaet Frankfurt

    Frankfurt Am Main, 60590
    Germany

    Site Not Available

  • Universitaetsmedizin Goettingen

    Gottingen, 37075
    Germany

    Site Not Available

  • Magdeburger Company For Medical Studies and Services Gmbh

    Magdeburg, 39104
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Dres. Quist

    Mainz, 55128
    Germany

    Site Not Available

  • Technischen Universitaet Muenchen

    Muenchen, 80802
    Germany

    Site Not Available

  • University Hospital Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Klinikum Oldenburg Aor

    Oldenburg, 26133
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Hoffmann

    Witten, 58453
    Germany

    Site Not Available

  • Tokyo Medical and Dental University Hospital, Faculty of Medicine

    Bunkyo-ku, 113-8519
    Japan

    Site Not Available

  • Tokyo Medical University Ibaraki Medical Center - Kasumigaura Campus (Tokyo Medical University Kasum

    Inashiki-gun,
    Japan

    Site Not Available

  • Noguchi Dermatology Clinic

    Kamimashiki-gun, 861-3101
    Japan

    Site Not Available

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki-shi, 211-8533
    Japan

    Site Not Available

  • University of Occupational and Environmental Health, Japan

    Kitakyushu, 807-8555
    Japan

    Site Not Available

  • Shimizu Dermatology Clinic

    Kobe, 657¿0846
    Japan

    Site Not Available

  • Dokkyo Medical University Saitama Medical Center

    Minamikoshigaya, 343-8555
    Japan

    Site Not Available

  • Tanpopo Dermatology Clinic

    Ota-ku, 143-0023
    Japan

    Site Not Available

  • Kume Derma Clinic

    Sakai, 593-8324
    Japan

    Site Not Available

  • Sapporo Skin Clinic

    Sapporo, 600063
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, 980-8574
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023
    Japan

    Site Not Available

  • Akk Medical Sp. Z O.O. - Centrum Medyczne Tu Sie Leczy

    Gdansk, 80-280
    Poland

    Site Not Available

  • Care Clinic Sp. Z O.O.

    Katowice, 40-568
    Poland

    Site Not Available

  • Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, 90-436
    Poland

    Site Not Available

  • Santa Familia Ptg Lodz

    Lodz, 90-302
    Poland

    Site Not Available

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota Krasowska

    Lublin, 20-573
    Poland

    Site Not Available

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

  • Clinical Research Center Spolka Z Ograniczona Odpowiedzialnoscia Medic-R Spolka Komandytowa

    Poznan, 61731
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z O.O.

    Tarnow, 33-100
    Poland

    Site Not Available

  • Mics Centrum Medyczne Torun

    Torun, 87-100
    Poland

    Site Not Available

  • High-Med. Przychodnia Specjalistyczna

    Warszawa, 01-817
    Poland

    Site Not Available

  • Panstwowy Instytut Medyczny Mswia

    Warszawa, 02-507
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warszawa, 02-692
    Poland

    Site Not Available

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

    Wroclaw, 50566
    Poland

    Site Not Available

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias I Pujol (Hugtp)

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Clinico Universitario San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222
    Spain

    Site Not Available

  • Hospital de Manises

    Manises, 46940
    Spain

    Site Not Available

  • Area Sanitaria de Santiago de Compostela Y Barbanza - Complejo Hospitalario Universitario de Santiag

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013
    Spain

    Site Not Available

  • Hospital Universitari I Politecnic La Fe de Valencia - Instituto de Investigacion Sanitaria La Fe (I

    Valencia, 46026
    Spain

    Site Not Available

  • Ipswich Hospital, East Suffolk and North Essex Nhs Foundation Trust

    Colchester, CO4 5JL
    United Kingdom

    Site Not Available

  • The Dudley Group Nhs Foundation Trust

    Dudley, DY1 2HQ
    United Kingdom

    Site Not Available

  • Harrogate District Hospital - Harrogate and District Nhs Foundation Trust

    Harrogate, HG2 7SX
    United Kingdom

    Site Not Available

  • Broadgreen Hospital - Liverpool University Hospitals Nhs Foundation Trust

    Liverpool, L14 3LB
    United Kingdom

    Site Not Available

  • Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • The Royal London Hospital - Barts Health Nhs Trust

    London, E1 1FR
    United Kingdom

    Site Not Available

  • Poole Hospital - University Hospitals Dorset Nhs Foundation Trust

    Poole, BH15 2JB
    United Kingdom

    Site Not Available

  • Surrey and Sussex Healthcare Nhs Trust - East Surrey Hospital

    Redhill,
    United Kingdom

    Site Not Available

  • Medical Dermatology Specialists Phoenix

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Clear Dermatology and Aesthetics Center

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Investigate Md

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • Premier Dermatology Clinical Trials Institute At Northwest Arkansas

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • First Oc Dermatology Research Inc

    Fountain Valley, California 92708-3701
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Integrative Skin Science and Research

    Sacramento, California 95815
    United States

    Site Not Available

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica, California 90404
    United States

    Site Not Available

  • Center For Clinical and Cosmetic Research

    Aventura, Florida 33180
    United States

    Site Not Available

  • Clearlyderm Dermatology

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Total Vein and Skin Llc

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Driven Research Llc

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Boynton Beach Facility

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Skin Care Research, Llc Scr Hollywood

    Hollywood, Florida 33201
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida 33125
    United States

    Site Not Available

  • Ziaderm Research, Llc

    Miami, Florida 33162
    United States

    Active - Recruiting

  • Dh Tamarac Research Center Etna Medical Center Emc

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Nodal Medical Center, Llc

    Tampa, Florida 33607
    United States

    Site Not Available

  • Chicago Cosmetic Surgery and Dermatology

    Chicago, Illinois 60654
    United States

    Site Not Available

  • Dermatology Specialists Research Indiana

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Southern Indiana Clinical Trials

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Dermatology Specialists Research

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Tulane University Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Dermatology Associates Pc

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Metro Boston Clinical Partners

    Brighton, Massachusetts 02135-3511
    United States

    Active - Recruiting

  • Fivenson Dermatology

    Ann Arbor, Michigan 48103
    United States

    Active - Recruiting

  • Michigan Center For Research Company

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Site Not Available

  • Michigan Dermatology Institute

    Waterford, Michigan 48328
    United States

    Active - Recruiting

  • Medisearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Allcutis Research, Llc

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Schweiger Dermatology

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Suny Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Equity Medical, Llc

    New York, New York 100233
    United States

    Site Not Available

  • OPTISKIN

    New York, New York 10128
    United States

    Active - Recruiting

  • Oakview Dermatology

    Athens, Ohio 45701
    United States

    Site Not Available

  • University of Cincinnati Health Physicians

    Cincinnati, Ohio 45213
    United States

    Site Not Available

  • Centricity Research Aventiv Research Dublin

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Central Sooner Research

    Oklahoma City, Oklahoma 73118
    United States

    Active - Recruiting

  • Paddington Testing Co Inc

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • Yardley Dermatology Associates

    Yardley, Pennsylvania 19067
    United States

    Site Not Available

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Modern Research Associates Pllc

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Acclaim Dermatology, Pllc

    Sugar Land, Texas 77479-2645
    United States

    Site Not Available

  • University of Utah Midvalley Dermatology

    Murray, Utah 84107
    United States

    Site Not Available

  • Aesthetic General Dermatology of Seattle

    Seattle, Washington 98168
    United States

    Active - Recruiting

  • West Virginia Research Institute

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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