A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
NCT ID: NCT05764161
Last Updated: 2025-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
190 participants
INTERVENTIONAL
2023-06-12
2025-11-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ruxolitinib 1.5% Cream
Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
Vehicle Cream
Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.
Interventions
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Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening 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 Criteria
* 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 interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
* Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
* Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of 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 the judicial 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 Public Health Code.
2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
3. Individuals not affiliated with the social security system.
18 Years
99 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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University of Alabama At Birmingham
Birmingham, Alabama, United States
Northwest Arkansas Clinical Trials Center
Arkansas City, Arkansas, United States
Dermatology Research Associates
Los Angeles, California, United States
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, United States
Cura Clinical Research
Sherman Oaks, California, United States
Ars - Maitland Clinical Research Unit
Orlando, Florida, United States
Marietta Dermatology the Skin Cancer Center Marietta
Marietta, Georgia, United States
The South Bend Clinic Main Campus
South Bend, Indiana, United States
Axon Clinical Research
Baltimore, Maryland, United States
Activmed Practices Research, Llc Beverly
Beverly, Massachusetts, United States
Oakview Dermatology
Athens, Ohio, United States
Aventiv Research Inc-Dublin
Dublin, Ohio, United States
Wright State Physicians, Inc.
Fairborn, Ohio, United States
University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
Pittsburgh, Pennsylvania, United States
Dermdox Center For Dermatology
Sugarloaf, Pennsylvania, United States
Dermresearch, Inc.
Austin, Texas, United States
Premier Specialists Pty Ltd
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Paratus Clinical Research, Woden
Phillip, , Australia
Landeskrankenhaus Universitatsklinikum Graz
Graz, , Austria
Ordensklinikum Linz Gmbh Elisabethinen
Linz, , Austria
Sozialmedizinisches Zentrum Ost-Donauspital
Vienna, , Austria
Medical Center Medconsult Pleven Ood
Pleven, , Bulgaria
Medical Center- Prolet Ltd
Rousse, , Bulgaria
Medical Center Unimed Eood
Sevlievo, , Bulgaria
Dcc 'Alexandrovska', Eood
Sofia, , Bulgaria
Medical Center Hera Eood
Sofia, , Bulgaria
Umhat Prof. Dr. Stoyan Kirkovich Ad
Stara Zagora, , Bulgaria
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
North York Research Inc.
North YORK, Ontario, Canada
Skin Centre For Dermatology
Peterborough, Ontario, Canada
Diex Recherche Quebec Inc.
Québec, Quebec, Canada
Herlev Og Gentofte Hospital
Hellerup, , Denmark
Sjaellands Universitetshospital
Roskilde, , Denmark
Bordeaux Chu Hopital Saint - Andre
Bordeaux, , France
Chu Dijon-Bourgogne
Dijon, , France
Hopital Edouard Herrio
Lyon, , France
Chu de Nice - Hospital L Archet
Nice, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Chu Amiens - Hopital Sud
Salouël, , France
Klinikum Bielefeld Rosenhohe Dermatologie
Bielefeld, , Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitatsmedizin Goettingen
Göttingen, , Germany
Dermatologische Gemeinschaftspraxis Mahlow
Mahlow, , Germany
Universitatsklinikum Munster
Münster, , Germany
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, , Italy
Universita Degli Studi Della Campania Luigi Vanvitelli
Napoli, , Italy
Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia
Perugia, , Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
Pisa, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, , Italy
Diamond Clinic Specjalistyczne Poradnie Lekarskie
Krakow, , Poland
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
Lodz, , Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny
Lublin, , Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
Malbork, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Dermaceum Centrum Badan Klinicznych
Wroclaw, , Poland
Dermmedica Sp. Z O.O.
Wroclaw, , Poland
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary'S Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Ceim Hospital Universitari Germans Trias I Pujol
Badalona, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Clinica Gaias Santiago
Santiago de Compostela, , Spain
Dermatology & Skin Care Clinic
Buochs, , Switzerland
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, , Switzerland
Universitatsspital Zurich
Zurich-flughafen, , Switzerland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-502461-23-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB18424-320
Identifier Type: -
Identifier Source: org_study_id