A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN1)
Prurigo
About this trial
This is an interventional treatment trial for Prurigo focused on measuring Prurigo, Prurigo Nodularis, PN, Skin Diseases, Dermatitis, Eczematous, ruxolitinib, INCB 18424
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of PN ≥ 3 months before screening. ≥ 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: 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 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: Vulnerable populations according to article L.1121-6 of the French Public Health Code. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code. Individuals not affiliated with the social security system.
Sites / Locations
- University of Alabama At Birmingham
- Medical Dermatology Specialists PhoenixRecruiting
- Johnson DermatologyRecruiting
- First Oc DermatologyRecruiting
- University of Miami
- Dermatology Associates PcRecruiting
- Clarkston Medical GroupRecruiting
- Revival Research Institute, Llc TroyRecruiting
- Medisearch Clinical TrialsRecruiting
- Wake Forest University
- UC Health, Llc
- University Hospitals Cleveland Medical CenterRecruiting
- Central Sooner ResearchRecruiting
- Dermatology Associates of Plymouth MeetingRecruiting
- Medical University of South Carolina
- International Clinical Research Tennessee LlcRecruiting
- North Texas Center For Clinical Research Ntccr
- Austin Institute For Clinical Research Aicr PflugervilleRecruiting
- Center For Clinical StudiesRecruiting
- Premier Clinical ResearchRecruiting
- Conexa Investigacion Clinica S.A.
- Cedic Centro de Investigaciones ClinicasRecruiting
- Buenos Aires Skin
- Psoriahue-Medicina InterdisciplinarRecruiting
- Cinme - Centro de Investigaciones Metabolicas
- Centro de Investigaciones Medicas Mar Del PlataRecruiting
- Fundacion ScherbovskyRecruiting
- Hospital Universitario Austral
- Instituto de Especialidades de La Salud Rosario
- Centro de Investigaciones Medicas TucumanRecruiting
- Cliniques Universitaires Ucl Saint-Luc
- Ulb Hospital Erasme
- Az Sint-LucasRecruiting
- Universitair Ziekenhuis Gent
- Universitair Ziekenhuis (Uz) Leuven
- Centre Hospitalier Universitaire de Liege - Sart Tilman
- Chu Ucl Namur de Saint Elisabeth
- Beacon DermatologyRecruiting
- Simcomed Health LtdRecruiting
- DermeffectsRecruiting
- Toronto Research CentreRecruiting
- Centre de Recherche Saint-LouisRecruiting
- Centro Medico Skinmed
- Ciec - Centro Internacional de Estudios Cli-Nicos
- Clinical Research Chile Spa.
- Hospital Prive D'Antony
- Hospital Morvan
- Chru de Lille Hopital Claude Huriez
- Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
- University Hospital of Saint Etienne
- University Medical Center Rwth Aachen
- Fachklinik Bad Bentheim DermatologieRecruiting
- Universitaetsklinikum Carl Gustav Carus Tu DresdenRecruiting
- Universitatsklinikum Schleswig Holstein
- Universitaetsmedizin Der Johannes-Gutenberg-Universitaet Mainz
- Universitats-Hautklink Tubingen
- Hautarztpraxis Dr. Med. Matthias Hoffmann
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
- Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
- Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore
- Polyclinic Federico Ii
- Fondazione Policlinico Universitario Agostino Gemelli Irccs
- Istituto Clinico Humanitas
- Ospedali Riuniti Di Ancona
- Amsterdam University Medical Centre
- Bravis Ziekenhuis
- Pratia McM Krakow
- ETG LODZ
- Luxderm Specjalistyczny Gabinet Dermatologiczny
- Kliniczny Szpital Wojewodzki Nr 1 Im.F.Chopina
- Clinical Research Group Sp. Z.O.ORecruiting
- Dorota Bystrzanowska 'High-Med'. Przychodnia Specjalistyczna
- Centralny Szpital Kliniczny Mswia
- Hospital General Unviersitario de Alicante
- Hospital Universitario Reina Sofia
- Hospital de Manises
- Hospital Universitario Quironsalud Madrid
- Complejo Hospitalario Universitario de Santiago
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Vehicle Cream BID
Ruxolitinib 1.5% 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 apply ruxolitinib 1.5% cream topically during the open label extension (OLE) period for up to 40 weeks.
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 apply ruxolitinib 1.5% cream the open label extension (OLE) period for up to 40 weeks.