A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) (TRuE-PN2)
Prurigo Nodularis
About this trial
This is an interventional treatment trial for Prurigo Nodularis focused on measuring PN, INCB18424-320, INCB18424, Prurigo, Prurigo Nodularis, Skin Diseases, Dermatitis, ruxolitinib
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
- Northwest Arkansas Clinical Trials CenterRecruiting
- Dermatology Research AssociatesRecruiting
- Clinical Science Institute Clinical Research Specialists IncRecruiting
- Cura Clinical ResearchRecruiting
- Ars - Maitland Clinical Research UnitRecruiting
- Marietta Dermatology the Skin Cancer Center Marietta
- The South Bend Clinic Main CampusRecruiting
- Activmed Practices Research, Llc BeverlyRecruiting
- Beth Israel Deaconess Medical Center (Bidmc)
- Oakview DermatologyRecruiting
- Aventiv Research Inc-DublinRecruiting
- Wright State Physicians, Inc.Recruiting
- University of Pennsylvania-Perelman School of Medicine
- University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
- Dermdox Center For DermatologyRecruiting
- Dermresearch, Inc.Recruiting
- Premier Specialists Pty Ltd
- Novatrials
- Liverpool Hospital
- Holdsworth House Medical Practice
- Westmead Hospital
- Veracity Clinical Research
- The Alfred Hospital
- Paratus Clinical Research, Woden
- Landeskrankenhaus Universitatsklinikum Graz
- Ordensklinikum Linz Gmbh Elisabethinen
- Sozialmedizinisches Zentrum Ost-Donauspital
- Medical Center Medconsult Pleven Ood
- Medical Center- Prolet Ltd
- Medical Center Unimed Eood
- Dcc 'Alexandrovska', Eood
- Medical Center Hera Eood
- Umhat 'Prof. Dr. St. Kirkovich', Ad
- Kingsway Clinical ResearchRecruiting
- Lynderm Research IncRecruiting
- North York Research Inc.Recruiting
- Skin Centre For DermatologyRecruiting
- Diex Recherche Quebec Inc.Recruiting
- Karma Clinical Trials Inc.
- Herlev Og Gentofte Hospital
- Sjaellands Universitetshospital
- Bordeaux Chu Hopital Saint - Andre
- Chu Dijon-Bourgogne
- Hopital Edouard Herriot - Chu Lyon
- Chu de Nice - Hospital L Archet
- Hospital Saint Louis
- Centre Hospitalier Universitaire de Poitiers
- Chu de Rouen - Hospital Charles Nicolle
- Chu Amiens - Hopital Sud
- Klinikum Bielefeld Rosenhohe Dermatologie
- Universitatsklinikum Frankfurt
- Universitatsmedizin Goettingen
- Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian
- Universitaetsklinikum Muenster
- Company For Medical Study & Service Selters Gmbh
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
- Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli
- Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
- Azienda Ospedaliero Universitaria Pisana
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Korea University Anam Hospital
- Seoul National University Hospital
- Asan Medical Center
- The Catholic University of Korea Seoul St. Mary'S Hospital
- Korea University Guro Hospital
- Ajou University Hospital
- Diamond Clinic Specjalistyczne Poradnie Lekarskie
- Dermoklinika
- Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
- Solumed Centrum Medyczne
- Dermaceum Centrum Badan Klinicznych
- Dermmedica Sp. Z O.O.
- Hospital Universitari Germans Trias I Pujol
- Hospital Universitario de Gran Canaria Doctor Negrin
- Hospital Universitario Ramon Y Cajal
- Hospital Universitario 12 de Octubre
- Clinica Gaias Santiago
- Dermatology & Skin Care Clinic
- Centre Hospitalier Universitaire Vaudois
- Universitaetsspital Zuerich
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ruxolitinib 1.5% Cream
Vehicle 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.
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.