A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

Last updated: November 12, 2025
Sponsor: Incyte Corporation
Overall Status: Completed

Phase

3

Condition

Warts

Eczema (Atopic Dermatitis)

Allergy

Treatment

Ruxolitinib Cream

Vehicle Cream

Clinical Study ID

NCT05764161
INCB18424-320
2022-502461-23-00
  • Ages 18-99
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of PN ≥ 3 months before screening.

  • ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) atscreening and baseline having a treatment area <20% BSA.

  • IGA-CPG-S score of ≥ 2 at screening and baseline.

  • Baseline PN-related WI-NRS score ≥ 7.

  • Willingness to avoid pregnancy or fathering children.

Exclusion

Exclusion Criteria:

  • Chronic pruritus due to a condition other than PN

  • Total estimated BSA treatment area (excluding the scalp) > 20%.

  • Neuropathic and psychogenic pruritus

  • Active atopic dermatitis lesions within 3 months of screening and baseline.

  • Uncontrolled thyroid function

  • Concurrent skin or other serious or unstable medical conditions which may interferewith the evaluation of PN such as immunocompromised status, acute/chronicinfections, active malignancy, history of TB, history of DVT/VTE, etc Protocoldefined abnormal laboratory results.

  • Use of any protocol-defined prohibited medication unless a washout is completed oruse of medication known to cause itching.

  • Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baselineor Ultraviolet light therapy or prolonged exposure to natural or artificial sourcesof ultraviolet radiation (within 2 weeks before baseline

  • Pregnant or lactating, or considering pregnancy.

  • History of alcoholism or drug addiction within 1 year

  • Known allergy or reaction to any of the components of the study drug.

  • Committed to a mental health institution by virtue of an order issued either by thejudicial or the administrative authorities.

  • Employees of the sponsor or investigator or otherwise dependents of them.

  • The following participants are excluded in France:

  1. Vulnerable populations according to article L.1121-6 of the French PublicHealth Code.

  2. Adults under legal protection or who are unable to express their consent perarticle L.1121-8 of the French Public Health Code.

  3. Individuals not affiliated with the social security system.

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Ruxolitinib Cream
Phase: 3
Study Start date:
June 12, 2023
Estimated Completion Date:
November 04, 2025

Study Description

The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.

Connect with a study center

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales 02217
    Australia

    Site Not Available

  • Novatrials

    Kotara, New South Wales 02289
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 02170
    Australia

    Site Not Available

  • Holdsworth House Medical Practice

    Sydney, New South Wales 02010
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney, New South Wales 02145
    Australia

    Site Not Available

  • Premier Specialists Pty Ltd

    Kogarah 2161185, New South Wales 2155400 02217
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool 2159851, New South Wales 2155400 02170
    Australia

    Site Not Available

  • Holdsworth House Medical Practice

    Sydney 2147714, New South Wales 2155400 02010
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney 2147714, New South Wales 2155400 02145
    Australia

    Site Not Available

  • Veracity Clinical Research

    Woolloongabba, Queensland 04102
    Australia

    Site Not Available

  • Veracity Clinical Research

    Woolloongabba 6943568, Queensland 2152274 04102
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 03004
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 03004
    Australia

    Site Not Available

  • Paratus Clinical Research, Woden

    Phillip, 02606
    Australia

    Site Not Available

  • Paratus Clinical Research, Woden

    Phillip 2153335, 02606
    Australia

    Site Not Available

  • Landeskrankenhaus Universitatsklinikum Graz

    Graz, 08036
    Austria

    Site Not Available

  • Landeskrankenhaus Universitatsklinikum Graz

    Graz 2778067, 08036
    Austria

    Site Not Available

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 04020
    Austria

    Site Not Available

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz 2772400, 04020
    Austria

    Site Not Available

  • Sozialmedizinisches Zentrum Ost-Donauspital

    Vienna, 01220
    Austria

    Site Not Available

  • Sozialmedizinisches Zentrum Ost-Donauspital

    Vienna 2761369, 01220
    Austria

    Site Not Available

  • Medical Center Medconsult Pleven Ood

    Pleven, 05800
    Bulgaria

    Site Not Available

  • Medical Center Medconsult Pleven Ood

    Pleven 728203, 05800
    Bulgaria

    Site Not Available

  • Medical Center- Prolet Ltd

    Rousse 727523, 07000
    Bulgaria

    Site Not Available

  • Medical Center- Prolet Ltd

    Ruse, 07000
    Bulgaria

    Site Not Available

  • Medical Center Unimed Eood

    Sevlievo, 05400
    Bulgaria

    Site Not Available

  • Medical Center Unimed Eood

    Sevlievo 727337, 05400
    Bulgaria

    Site Not Available

  • Dcc 'Alexandrovska', Eood

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Medical Center Hera Eood

    Sofia, 01510
    Bulgaria

    Site Not Available

  • Dcc 'Alexandrovska', Eood

    Sofia 727011, 01431
    Bulgaria

    Site Not Available

  • Medical Center Hera Eood

    Sofia 727011, 01510
    Bulgaria

    Site Not Available

  • Umhat 'Prof. Dr. St. Kirkovich', Ad

    Stara Zagora, 06000
    Bulgaria

    Site Not Available

  • Umhat Prof. Dr. Stoyan Kirkovich Ad

    Stara Zagora, 06000
    Bulgaria

    Site Not Available

  • Umhat Prof. Dr. Stoyan Kirkovich Ad

    Stara Zagora 726848, 06000
    Bulgaria

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • North York Research Inc.

    North York, Ontario M2M 4J5
    Canada

    Site Not Available

  • Skin Centre For Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Kingsway Clinical Research

    Etobicoke 5950268, Ontario 6093943 M8X 1Y9
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham 6066513, Ontario 6093943 L3P 1X3
    Canada

    Site Not Available

  • North York Research Inc.

    North YORK, Ontario 6093943 M2M 4J5
    Canada

    Site Not Available

  • Skin Centre For Dermatology

    Peterborough 6101645, Ontario 6093943 K9J 5K2
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc.

    Québec 6325494, Quebec 6115047 G1V 4T3
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc.

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Karma Clinical Trials Inc.

    St. John's, A1A 4Y3
    Canada

    Site Not Available

  • Herlev Og Gentofte Hospital

    Hellerup, 02900
    Denmark

    Site Not Available

  • Herlev Og Gentofte Hospital

    Hellerup 2620516, 02900
    Denmark

    Site Not Available

  • Sjaellands Universitetshospital

    Roskilde, 04000
    Denmark

    Site Not Available

  • Sjaellands Universitetshospital

    Roskilde 2614481, 04000
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Århus N, 08200
    Denmark

    Site Not Available

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux, 33000
    France

    Site Not Available

  • Bordeaux Chu Hopital Saint - Andre

    Bordeaux 3031582, 33000
    France

    Site Not Available

  • Chu Dijon-Bourgogne

    Dijon, 21000
    France

    Site Not Available

  • Chu Dijon-Bourgogne

    Dijon 3021372, 21000
    France

    Site Not Available

  • Hopital Edouard Herrio

    Lyon, 69003
    France

    Site Not Available

  • Hopital Edouard Herriot - Chu Lyon

    Lyon, 69003
    France

    Site Not Available

  • Hopital Edouard Herrio

    Lyon 2996944, 69003
    France

    Site Not Available

  • Chu de Nice - Hospital L Archet

    Nice 2990440, 06200
    France

    Site Not Available

  • Chu de Nice - Hospital L Archet

    Nice Cedex 3, 06200
    France

    Site Not Available

  • Hospital Saint Louis

    Paris, 75010
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers 2986495, 86021
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers Cedex, 86021
    France

    Site Not Available

  • Chu de Rouen - Hospital Charles Nicolle

    Rouen, 76000
    France

    Site Not Available

  • Chu Amiens - Hopital Sud

    Salouel, 80480
    France

    Site Not Available

  • Chu Amiens - Hopital Sud

    Salouël 2976337, 80480
    France

    Site Not Available

  • Klinikum Bielefeld Rosenhohe Dermatologie

    Bielefeld, 33647
    Germany

    Site Not Available

  • Klinikum Bielefeld Rosenhohe Dermatologie

    Bielefeld 2949186, 33647
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt Am Main, 60590
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt am Main 2925533, 60590
    Germany

    Site Not Available

  • Universitatsmedizin Goettingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitatsmedizin Goettingen

    Göttingen 2918632, 37075
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Mahlow

    Mahlow, 15831
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian

    Mahlow, 15831
    Germany

    Site Not Available

  • Dermatologische Gemeinschaftspraxis Mahlow

    Mahlow 2874461, 15831
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Muenster, 48149
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Muenster, 48149
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Münster 2867543, 48149
    Germany

    Site Not Available

  • Company For Medical Study & Service Selters Gmbh

    Selters, 56242
    Germany

    Site Not Available

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan 6951411, 20122
    Italy

    Site Not Available

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milano, 20122
    Italy

    Site Not Available

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli

    Napoli, 80131
    Italy

    Active - Recruiting

  • Universita Degli Studi Della Campania Luigi Vanvitelli

    Napoli, 80131
    Italy

    Site Not Available

  • Universita Degli Studi Della Campania Luigi Vanvitelli

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia

    Perugia, 06132
    Italy

    Site Not Available

  • Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia

    Perugia, 06132
    Italy

    Site Not Available

  • Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia

    Perugia 3171180, 06132
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

    Pisa, 56126
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

    Pisa 3170647, 56126
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, 00133
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome 3169070, 00133
    Italy

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

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

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Diamond Clinic Specjalistyczne Poradnie Lekarskie

    Krakow, 31-559
    Poland

    Site Not Available

  • Diamond Clinic Specjalistyczne Poradnie Lekarskie

    Krakow 3094802, 31-559
    Poland

    Site Not Available

  • Dermoklinika

    Lodz, 90-436
    Poland

    Site Not Available

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

    Lodz, 90-436
    Poland

    Site Not Available

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

    Lodz 3093133, 90-436
    Poland

    Site Not Available

  • Luxderm Specjalistyczny Gabinet Dermatologiczny

    Lublin, 20-362
    Poland

    Site Not Available

  • Luxderm Specjalistyczny Gabinet Dermatologiczny

    Lublin 765876, 20-362
    Poland

    Site Not Available

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

    Malbork, 82-200
    Poland

    Site Not Available

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

    Malbork 3092472, 82-200
    Poland

    Site Not Available

  • Solumed Centrum Medyczne

    Poznan, 60-529
    Poland

    Site Not Available

  • Solumed Centrum Medyczne

    Poznan 3088171, 60-529
    Poland

    Site Not Available

  • Dermaceum Centrum Badan Klinicznych

    Wroclaw, 50-414
    Poland

    Site Not Available

  • Dermmedica Sp. Z O.O.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • Dermaceum Centrum Badan Klinicznych

    Wroclaw 3081368, 50-414
    Poland

    Site Not Available

  • Dermmedica Sp. Z O.O.

    Wroclaw 3081368, 51-318
    Poland

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Site Not Available

  • Korea University Anam Hospital

    Seoul 1835848, 02841
    South Korea

    Site Not Available

  • Korea University Guro Hospital

    Seoul 1835848, 08308
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

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

    Seoul 1835848, 06591
    South Korea

    Site Not Available

  • Ajou University Hospital

    Suwon 1835553, 16499
    South Korea

    Site Not Available

  • Ceim Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Ceim Hospital Universitari Germans Trias I Pujol

    Badalona 3129028, 08916
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, 35010
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria 2515270, 35010
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hospital Universitario Ramon Y Cajal

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Clinica Gaias Santiago

    Santiago de Compostela, 15002
    Spain

    Site Not Available

  • Clinica Gaias Santiago

    Santiago de Compostela 3109642, 15002
    Spain

    Site Not Available

  • Dermatology & Skin Care Clinic

    Buochs, 06374
    Switzerland

    Site Not Available

  • Dermatology & Skin Care Clinic

    Buochs 2661328, 06374
    Switzerland

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011
    Switzerland

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne, 01011
    Switzerland

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne 2659994, 01011
    Switzerland

    Site Not Available

  • Universitatsspital Zurich

    Zuerich, 08091
    Switzerland

    Site Not Available

  • Universitatsspital Zurich

    Zurich-flughafen, 08058
    Switzerland

    Site Not Available

  • Universitaetsspital Zuerich

    Zürich-flughafen, 08058
    Switzerland

    Site Not Available

  • University of Alabama At Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama At Birmingham

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Northwest Arkansas Clinical Trials Center

    Arkansas, Arkansas 72758
    United States

    Site Not Available

  • Northwest Arkansas Clinical Trials Center

    Arkansas City 4099673, Arkansas 4099753 72758
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Site Not Available

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica, California 90404
    United States

    Site Not Available

  • Cura Clinical Research

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica 5393212, California 5332921 90404
    United States

    Site Not Available

  • Cura Clinical Research

    Sherman Oaks 5395244, California 5332921 91403
    United States

    Site Not Available

  • Ars - Maitland Clinical Research Unit

    Orlando, Florida 32819
    United States

    Site Not Available

  • Pureskin Dermatology and Aesthetics

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Ars - Maitland Clinical Research Unit

    Orlando 4167147, Florida 4155751 32819
    United States

    Site Not Available

  • Marietta Dermatology the Skin Cancer Center Marietta

    Marietta, Georgia 30060-1047
    United States

    Site Not Available

  • Marietta Dermatology the Skin Cancer Center Marietta

    Marietta 4207783, Georgia 4197000 30060-1047
    United States

    Site Not Available

  • The South Bend Clinic Main Campus

    South Bend, Indiana 46617
    United States

    Site Not Available

  • The South Bend Clinic Main Campus

    South Bend 4926563, Indiana 4921868 46617
    United States

    Site Not Available

  • Axon Clinical Research

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Johns Hopkins Univ Schl of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Axon Clinical Research

    Baltimore 4347778, Maryland 4361885 21237
    United States

    Site Not Available

  • Activmed Practices Research, Llc Beverly

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center (Bidmc)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Activmed Practices Research, Llc Beverly

    Beverly 4930505, Massachusetts 6254926 01915
    United States

    Site Not Available

  • Montefiore Medical Center (Mmc)

    Bronx, New York 10467
    United States

    Site Not Available

  • Oakview Dermatology

    Athens, Ohio 45701
    United States

    Site Not Available

  • Aventiv Research Inc-Dublin

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Wright State Physicians, Inc.

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Oakview Dermatology

    Athens 4505542, Ohio 5165418 45701
    United States

    Site Not Available

  • Aventiv Research Inc-Dublin

    Dublin 5152333, Ohio 5165418 43016
    United States

    Site Not Available

  • Wright State Physicians, Inc.

    Fairborn 4511263, Ohio 5165418 45324
    United States

    Site Not Available

  • University of Pennsylvania-Perelman School of Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Dermdox Center For Dermatology

    Sugarloaf, Pennsylvania 18249
    United States

    Site Not Available

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

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • Dermdox Center For Dermatology

    Sugarloaf 13494940, Pennsylvania 6254927 18249
    United States

    Site Not Available

  • Dermresearch, Inc.

    Austin, Texas 78759
    United States

    Site Not Available

  • Dermresearch, Inc.

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

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