A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

Last updated: April 18, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Prurigo Nodularis

Atopic Dermatitis

Eczema (Atopic Dermatitis)

Treatment

Povorcitinib

Placebo

Clinical Study ID

NCT06516952
INCB54707-305
2024-511879-16-00
  • 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: Povorcitinib
Phase: 3
Study Start date:
October 10, 2024
Estimated Completion Date:
June 02, 2027

Connect with a study center

  • Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)

    Buenos Aires, C1425BEN
    Argentina

    Site Not Available

  • Instituto de Neumonologia Y Dermatologia

    Buenos Aires, C1425BEA
    Argentina

    Site Not Available

  • Buenos Aires Skin (Bas)

    Ciudad Autonoma de Buenos Aires, C1055AAO
    Argentina

    Site Not Available

  • Cedic - Consultorios Medicos

    Ciudad Autonoma de Buenos Aires, C1060ABN
    Argentina

    Active - Recruiting

  • Conexa Investigacion Clinica S.A.

    Ciudad Autonoma de Buenos Aires, 01012
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar Del Plata, B7600FYK
    Argentina

    Site Not Available

  • Instituto Especialidades de La Salud Rosario - Clinica Del Torax

    Rosario, S2000
    Argentina

    Active - Recruiting

  • Investigaciones Reumatologicas Tucuman S.R.L.

    San Miguel de Tucuman, T4000AXL
    Argentina

    Active - Recruiting

  • Medical University Graz University Clinic For Dermatology and Venerology

    Graz, 08036
    Austria

    Active - Recruiting

  • Wiener Krankenanstaltenverbund, Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhugel

    Wien, 01130
    Austria

    Site Not Available

  • Az 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

  • 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

  • Medical Center Medconsult Pleven Ood

    Lovech, 05500
    Bulgaria

    Active - Recruiting

  • Medconsult Pleven

    Pleven, 05800
    Bulgaria

    Active - Recruiting

  • Dcc (Diagnostic and Consultation Center) Pulmed

    Plovdiv, 04002
    Bulgaria

    Active - Recruiting

  • Medical Center- Prolet Ltd

    Ruse, 07000
    Bulgaria

    Active - Recruiting

  • Mc Unimed

    Sevlievo, 05400
    Bulgaria

    Site Not Available

  • Medical Center Unimed Eood

    Sevlievo, 05400
    Bulgaria

    Active - Recruiting

  • Diagnostic Consultative Center (Dcc) Aleksandrovska

    Sofia, 01431
    Bulgaria

    Active - Recruiting

  • Diagnostic Consulting Center Dcc Ascendent

    Sofia, 01202
    Bulgaria

    Active - Recruiting

  • Rao Dermatology

    Edmonton, Alberta T6G 1C3
    Canada

    Active - Recruiting

  • Enverus Medical Research

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Skin Health

    Cobourg, Ontario K9A 0Z4
    Canada

    Active - Recruiting

  • Centricity Research London Victoria Multispecialty

    London, Ontario N6A 2C2
    Canada

    Active - Recruiting

  • Dermeffects

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • North York Research Inc.

    Toronto, Ontario M2N 3A6
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique de Quebec

    Quebec City, Quebec G1V4X7
    Canada

    Active - Recruiting

  • Sima Recherche

    Verdun, Quebec H4G 3E7
    Canada

    Site Not Available

  • Hopital Prive D Antony

    Antony, 92160
    France

    Active - Recruiting

  • Chru Morvan/Chu Brest Hopital Morvan

    Brest, 29200
    France

    Active - Recruiting

  • Cabinet Medical- Chemin de Paradis

    Martigues, 13500
    France

    Site Not Available

  • Ghrmsa Hopital Emile Muller

    Mulhouse, 68100
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital Saint-Louis

    Paris, 75010
    France

    Active - Recruiting

  • Hopitaux Drome Nord - Site de Romans Sur Isere

    Romans Sur Isere, 26102
    France

    Active - Recruiting

  • Hopital Larrey

    Toulouse, 31400
    France

    Active - Recruiting

  • Aachen University Hospital

    Aachen, 52074
    Germany

    Site Not Available

  • University Hospital Rwth Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455
    Germany

    Active - Recruiting

  • Charite Universitatsmedizin Berlin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Hautzentrum Friedrichshain Studien

    Berlin, 10247
    Germany

    Active - Recruiting

  • Universitaetsklinikum Bonn Klinik Und Poliklinik Fuer Dermatologie Und Allergologie Klinisches Studi

    Bonn, 53105
    Germany

    Site Not Available

  • Studiengesellschaft An Der Hase Gbr

    Bramsche, 49565
    Germany

    Site Not Available

  • Klinikum Dortmund Ggmbh

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Universitaetsmedizin Goettingen

    Gottingen, 37075
    Germany

    Site Not Available

  • Universitaetsklinik Und Poliklinik Fuer Dermatologie Und Venerologie

    Halle, 06120
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitatsklinik Heidelberg

    Heidelberg, 69115
    Germany

    Active - Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck

    Luebeck, 23538
    Germany

    Active - Recruiting

  • Universitaetsmedizin Der Johannes - Gutenberg Universitaet Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Universitaetsklinikum Giessen Und Marburg Gmbh

    Marburg, 35043
    Germany

    Site Not Available

  • Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen

    Tuebingen, 72076
    Germany

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari

    Bari, 70124
    Italy

    Site Not Available

  • University of Bari Policlinico

    Bari, 70124
    Italy

    Site Not Available

  • Azienda Policlinico Vittorio Emanuele

    Catania, 95123
    Italy

    Site Not Available

  • Clinical Research Centre - Cast

    Chieti, 66013
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Firenze Centro Piero Palagi

    Firenze, 50125
    Italy

    Site Not Available

  • Presidio Ospedaliero Piero Palagi

    Firenze, 50125
    Italy

    Site Not Available

  • Azienda Sanitaria Locale 1 (Asl 1) - Ospedale Regionale San Salvatore

    L'aquila, 67100
    Italy

    Site Not Available

  • Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda

    Milano, 20122
    Italy

    Active - Recruiting

  • Universita Degli Studi Della Campania Luigi Vanvitelli

    Naples, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Di Perugia

    Perugia, 06129
    Italy

    Site Not Available

  • Ospedale S.Maria Della Misericordia

    Perugia, 06129
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

    Pisa, 56126
    Italy

    Active - Recruiting

  • Catholic University of the Sacred Heart

    Rome, 00168
    Italy

    Active - Recruiting

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Korea University Ansan Hospital

    Ansan-si, 15355
    Korea, Republic of

    Active - Recruiting

  • Soon Chun Hyang University Bucheon Hospital

    Bucheon-si, 14584
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital (Pnuh)

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Incheon St. Mary'S Hospital

    Incheon, 21431
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeonju-si, 54907
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital (Snubh)

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Seoul Hospital

    Seoul, 07804
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Seoul, 05030
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan-si, 50612
    Korea, Republic of

    Active - Recruiting

  • Amsterdam University Medical Center (Amsterdam Umc), Academic Medical Center (Amc)

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Amsterdam University Medical Centre

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Maxima Medisch Centrum

    Veldhoven, 5504 DB
    Netherlands

    Active - Recruiting

  • Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny Dermal

    Bialystok, 15-453
    Poland

    Active - Recruiting

  • Centrum Badan Klinicznych, Jagiellonskie Centrum Innowacji Sp.Z.O.O.

    Cracov, 30-348
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Site Not Available

  • Mazowieckie Centrum Badan Klinicznych

    Grodzisk Mazowiecki,
    Poland

    Active - Recruiting

  • Gyncentrum Sp. Z O.O., Nzoz Holsamed- Oddzial Libero

    Katowice, 40-600
    Poland

    Active - Recruiting

  • Pro Familia Altera Sp. Z O.O.

    Katowice, 40-648
    Poland

    Active - Recruiting

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

    Lublin, 20-573
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Med-Laser

    Lublin, 20-406
    Poland

    Active - Recruiting

  • Dermedic Jacek Zdybski

    Ostrowiec Swietokrzyski, 27-400
    Poland

    Site Not Available

  • Laser Clinic

    Szczecin, 70-332
    Poland

    Active - Recruiting

  • Mics Centrum Medyczne Torun

    Torun, 87-100
    Poland

    Site Not Available

  • Centrum Medyczne Evimed

    Warsaw, 02-625
    Poland

    Active - Recruiting

  • Clinical Research Group Sp. Z.O.O

    Warszawa, 01-142
    Poland

    Active - Recruiting

  • High-Med. Przychodnia Specjalistyczna

    Warszawa, 01-817
    Poland

    Site Not Available

  • Klinika Ambroziak Sp. Z O.O.

    Warszawa, 02-953
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny Mswia

    Warszawa, 02-507
    Poland

    Site Not Available

  • Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia

    Wrocaw, 54144
    Poland

    Active - Recruiting

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

    Wroclaw, 50566
    Poland

    Site Not Available

  • Dermaceum Centrum Badan Klinicznych

    Wroclaw, 50-450
    Poland

    Active - Recruiting

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

    Valencia, 46026
    Spain

    Site Not Available

  • Felix Platter Spital

    Basel, 04031
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern, 03010
    Switzerland

    Site Not Available

  • Dsc Clinic Buochs

    Buochs, 06374
    Switzerland

    Active - Recruiting

  • Universitatsspital Zurich

    Zurich, 08091
    Switzerland

    Active - Recruiting

  • Cahaba Dermatology

    Birmingham, Alabama 35244
    United States

    Active - Recruiting

  • Banner - University Medicine Multispecialty Services Clinic

    Tucson, Arizona 85718
    United States

    Site Not Available

  • Premier Dermatology Clinical Trials Institute At Northwest Arkansas

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas 71913
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Northridge

    Northridge, California 91325
    United States

    Active - Recruiting

  • Rendon Center the Dermatology and Aesthetic Center

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Driven Research Llc

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • University of Miami Miller School of Medicine

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Alliance Clinical Research Tampa

    Tampa, Florida 33615
    United States

    Site Not Available

  • Research Institute of the Southeast, Llc

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Center For Medical Dermatology and Immunology Research

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • Chicago Cosmetic Surgery and Dermatology

    Chicago, Illinois 60654
    United States

    Completed

  • Illinois Dermatology Institute the Chicago Loop

    Chicago, Illinois 60602
    United States

    Active - Recruiting

  • Northshore University Healthsystem

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Dermatology Specialists Research Ds Research Indiana Location

    Clarksville, Indiana 47129
    United States

    Active - Recruiting

  • Velocity Clinical Research At the Dermatology Clinic

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • H&H Research

    Metairie, Louisiana 70001
    United States

    Site Not Available

  • Oakland Hills Dermatology

    Auburn Hills, Michigan 48326
    United States

    Active - Recruiting

  • Hamzavi Dermatology

    Fort Gratiot, Michigan 48059
    United States

    Active - Recruiting

  • Somerset Skin Centre

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Medisearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • The University of New Mexico Unm Health Sciences Center Hsc

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • Montefiore Medical Center

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Skin Center Dermatology Group

    New York, New York 10956
    United States

    Active - Recruiting

  • Stony Brook Dermatology Associates

    Stony Brook, New York 11790
    United States

    Active - Recruiting

  • Oakview Dermatology

    Athens, Ohio 45701
    United States

    Site Not Available

  • Wright State Physicians Health Center

    Dayton, Ohio 45324
    United States

    Active - Recruiting

  • Centricity Research Aventiv Research Dublin

    Dublin, Ohio 43016
    United States

    Active - Recruiting

  • Dermdox Dermatology Centers, Pc

    Camp Hill, Pennsylvania 17011
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Palmetto Clinical Trial Services

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee 37130
    United States

    Active - Recruiting

  • Dermatology Treatment and Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Center For Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Sweetwater Dermatology

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Frontier Dermatology

    Mill Creek, Washington 98012
    United States

    Active - Recruiting

  • North Sound Dermatology

    Mill Creek, Washington 98012
    United States

    Site Not Available

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