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

Last updated: April 21, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Vehicle Cream

Ruxolitinib Cream

Clinical Study ID

NCT05755438
INCB 18424-319
  • 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: 204
Treatment Group(s): 2
Primary Treatment: Vehicle Cream
Phase: 3
Study Start date:
March 10, 2023
Estimated Completion Date:
August 10, 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

  • Conexa Investigacion Clinica S.A.

    Buenos Aires, 01012
    Argentina

    Site Not Available

  • Buenos Aires Skin

    Ciudad Autonoma Buenos Aires, C1055AAO
    Argentina

    Site Not Available

  • Cedic Centro de Investigaciones Clinicas

    Ciudad Autonoma Buenos Aires, 01125
    Argentina

    Site Not Available

  • Psoriahue-Medicina Interdisciplinar

    Ciudad Autonoma Buenos Aires, C1425DKG
    Argentina

    Site Not Available

  • Cinme - Centro de Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aire, C1056ABJ
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar Del Plata, B7600FYK
    Argentina

    Site Not Available

  • Fundacion Scherbovsky

    Mendoza, 05500
    Argentina

    Site Not Available

  • Hospital Universitario Austral

    Pilar, B1629ODT
    Argentina

    Site Not Available

  • Instituto de Especialidades de La Salud Rosario

    Rosario, S2000KPG
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucuman, T4000AXL
    Argentina

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 01200
    Belgium

    Site Not Available

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200
    Belgium

    Site Not Available

  • Ulb Hospital Erasme

    Bruxelles, 01070
    Belgium

    Site Not Available

  • Az Sint-Lucas

    Gent, 09000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 09000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 09000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis (Uz) Leuven

    Leuven, 03000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 04000
    Belgium

    Site Not Available

  • Chu Ucl Namur de Saint Elisabeth

    Namur, 05000
    Belgium

    Site Not Available

  • Pesquisare Saude

    Santo André, 09080-110
    Brazil

    Site Not Available

  • Beacon Dermatology

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • Simcomed Health Ltd

    Barrie, Ontario L4M 1G7
    Canada

    Site Not Available

  • Dermeffects

    London, Ontario N6H 5L4
    Canada

    Site Not Available

  • Research Toronto

    Toronto, Ontario M3H 5Y8
    Canada

    Site Not Available

  • Toronto Research Centre

    Toronto, Ontario M3H 5Y8
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis

    Québec, Quebec G1W 4R4
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Clinique Medicale St-Louis (Recherche) Inc D/B/A/ Centre de Recherche Saint-Louis

    Quebec, G1W 4R4
    Canada

    Site Not Available

  • Centro Medico Skinmed

    Las Condes, 7580206
    Chile

    Site Not Available

  • Ciec - Centro Internacional de Estudios Cli-Nicos

    Santiago, 8420383
    Chile

    Site Not Available

  • Clinical Research Chile Spa.

    Valdivia, 5090000
    Chile

    Site Not Available

  • Hospital Prive D'Antony

    Antony, 92160
    France

    Site Not Available

  • Hospital Morvan

    Brest Cedex 2, 29609
    France

    Site Not Available

  • Chru de Lille Hopital Claude Huriez

    Lille Cedex, 59037
    France

    Site Not Available

  • Hopital Claude Huriez - Chu Lille

    Lille Cedex, 59037
    France

    Site Not Available

  • Hospital Saint Joseph

    Marseille, 13008
    France

    Site Not Available

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

    Nantes, 44093
    France

    Site Not Available

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

    Nantes Cedex 1, 44120
    France

    Site Not Available

  • University Hospital of Saint Etienne

    Saint-etienne Cedex 2, 42270
    France

    Site Not Available

  • Universitaetsklinikum Aachen Aoer

    Aachen, 52074
    Germany

    Site Not Available

  • University Medical Center Rwth Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • Universitaetsmedizin Der Johannes-Gutenberg-Universitaet Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131
    Germany

    Site Not Available

  • Universitaetsklinikum Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Universitats-Hautklink Tubingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Med. Matthias Hoffmann

    Witten, 58453
    Germany

    Site Not Available

  • Ospedali Riuniti Di Ancona

    Ancona, 60126
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)

    Brescia, 25123
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria 'Policlinico - Vittorio Emanuele' (Presidio Gaspare Rodolico)

    Catania, 95123
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco

    Catania, 95123
    Italy

    Site Not Available

  • Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore

    Coppito, 67100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'

    Napoli, 80131
    Italy

    Site Not Available

  • Polyclinic Federico Ii

    Napoli, 80131
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma, 00137
    Italy

    Site Not Available

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Ospedali Riuniti Di Ancona

    Torrette, 60123
    Italy

    Site Not Available

  • Amsterdam Umc, Locatie Amc

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Amsterdam University Medical Centre

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Bravis Ziekenhuis

    Bergen Op Zoom, 4624 VT
    Netherlands

    Site Not Available

  • Pratia McM Krakow

    Krakow, 30-510
    Poland

    Site Not Available

  • ETG LODZ

    Lodz, 90-302
    Poland

    Site Not Available

  • Luxderm Specjalistyczny Gabinet Dermatologiczny

    Lublin, 20-362
    Poland

    Site Not Available

  • Kliniczny Szpital Wojewodzki Nr 1

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Kliniczny Szpital Wojewodzki Nr 1 Im.F.Chopina

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny Mswia

    Warszawa, 02-507
    Poland

    Site Not Available

  • Clinical Research Group Sp. Z.O.O

    Warszawa, 01-142
    Poland

    Site Not Available

  • Dorota Bystrzanowska 'High-Med'. Przychodnia Specjalistyczna

    Warszawa, 01-817
    Poland

    Site Not Available

  • High-Med Przychodnia Specjalistycza

    Warszawa, 01-817
    Poland

    Site Not Available

  • Hospital General Unviersitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital de Manises

    Manises, 46940
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • University of Alabama At Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Medical Dermatology Specialists Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • First Oc Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Dermatology Associates Pc

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Clarkston Medical Group

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Revival Research Institute, Llc Troy

    Troy, Michigan 48084
    United States

    Site Not Available

  • Medisearch Clinical Trials

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Montefiore Medical Center (Mmc)

    Bronx, New York 10467
    United States

    Site Not Available

  • Wake Forest University

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • UC Health, Llc

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • North Texas Center For Clinical Research Ntccr

    Frisco, Texas 75034
    United States

    Site Not Available

  • Austin Institute For Clinical Research Aicr Pflugerville

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Center For Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • West End Dermatology Associates

    Richmond, Virginia 23233
    United States

    Site Not Available

  • Premier Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

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