A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
Status: Recruiting
Location: See all (79) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in children (6 to \< 12 years old) with nonsegmental vitiligo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:
• Aged 6 to \< 12 years at the time of signing the ICF.
• Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI.
• Total body vitiligo area does not exceed 10% BSA.
• Pigmented hair within some of the areas of vitiligo on the face.
• Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.
• For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child as defined in the protocol.
Locations
Other Locations
Argentina
Consultorios Medicos Dr. Doreski
RECRUITING
Buenos Aires
Derma Internacional S.A.
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Instituto de Neumonologia Y Dermatologia
RECRUITING
Buenos Aires
Psoriahue
RECRUITING
Buenos Aires
Hospital Universitario Austral
RECRUITING
Derqui-pilar
Centro de Investigaciones Medicas Mar Del Plata
RECRUITING
Mar Del Plata
Hospital Del Nino Jesus
RECRUITING
San Miguel De Tucumán
Austria
Universitaetsklinikum Graz
RECRUITING
Graz
Medical University Innsbruck
RECRUITING
Innsbruck
Belgium
Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
RECRUITING
Woluwe-saint-lambert
Bulgaria
Medical Center Asklepii Ood
RECRUITING
Dupnitsa
Mhat Dr. Tota Venkova Ad
RECRUITING
Gabrovo
Medical Center Unimed Eood
RECRUITING
Sevlievo
28 Diagnostic and Consultative Center
RECRUITING
Sofia
Diagnostic Consultation Center Xx - Sofia Eood
RECRUITING
Sofia
Mc Euroderma Clinic
RECRUITING
Sofia
Umhat Aleksandrovska
RECRUITING
Sofia
Denmark
Herlev and Gentofte Hospital
RECRUITING
Hellerup
Sanos Clinic
RECRUITING
Herlev
France
Centre Hospitalier Victor Dupouy
RECRUITING
Argenteuil
Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin
RECRUITING
Bordeaux
Centre Hospitalier Intercommunal de Creteil
RECRUITING
Créteil
Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)
RECRUITING
Lyon
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
RECRUITING
Nantes
Centre Hospitalier Universitaire de Nice,Hopital L Archet
RECRUITING
Nice
Hopital Universitaire Necker Enfants Malades
RECRUITING
Paris
Polyclinique de Courlancy
NOT_YET_RECRUITING
Reims
Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey
RECRUITING
Toulouse
Chu Nancy
RECRUITING
Vandœuvre-lès-nancy
Germany
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)
RECRUITING
Berlin
Hautklinik Universitatsklinikum Erlangen
RECRUITING
Erlangen
Katholisches Kinderkrankenhaus Wilhelmstift
RECRUITING
Hamburg
University Medical Center Schleswig-Holstein
RECRUITING
Kiel
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
RECRUITING
Mainz
Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)
RECRUITING
München
University Hospital Muenster
RECRUITING
Münster
Hungary
Clinexpert
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
RECRUITING
Debrecen
University of Pecs-Clinical Center
RECRUITING
Pécs
University of Szeged
RECRUITING
Szeged
Italy
A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna
RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia
RECRUITING
Brescia
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
RECRUITING
Catania
Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
RECRUITING
Milan
Azienda Ospedaliero Universitaria Federico Ii Di Napoli
RECRUITING
Naples
Azienda Ospedale Universita Di Padova
RECRUITING
Padua
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli Irccs
RECRUITING
Rome
Irccs Ospedale Pediatrico Bambino Gesu
NOT_YET_RECRUITING
Rome
Netherlands
Amsterdam Umc Research Bv
RECRUITING
Amsterdam
Poland
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
RECRUITING
Gdansk
Care Clinic Sp. Z O.O.
RECRUITING
Katowice
Diamond Clinic Specjalistyczne Poradnie Lekarskie
RECRUITING
Krakow
Dermedic Iwona Zdybska
RECRUITING
Lublin
Twoja Przychodnia - Medyczne Nowa Sol
RECRUITING
Nowa Sól
Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski
RECRUITING
Osielsko
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
RECRUITING
Rzeszów
Twoja Przychodnia Scm
RECRUITING
Szczecin
Evimed Sp. Z O. O.
RECRUITING
Warsaw
Portugal
Centro Hospitalar E Universitario Coimbra
RECRUITING
Coimbra
Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos
RECRUITING
Lisbon
Hospital Geral de Santo Antonio
RECRUITING
Porto
Spain
Hospital Universitario Fundacion Alcorcon
RECRUITING
Alcorcón
Hospital Universitari Germans Trias I Pujol
RECRUITING
Badalona
Hospital de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hospital Sant Joan de Deu Barcelona
RECRUITING
Esplugues De Llobregat
Hospital Infantil Unversitario Nino Jesus
RECRUITING
Madrid
Hospital Universitario Miguel Servet de Zaragoza
RECRUITING
Zaragoza
United Kingdom
Croydon University Hospital
NOT_YET_RECRUITING
Croydon
Great Ormond Street Hospital For Children Nhs Foundation Trust
NOT_YET_RECRUITING
London
Guys Hospital
NOT_YET_RECRUITING
London
The Royal London Hospital - Barts Health Nhs Trust
RECRUITING
London
Sheffield Childrens Hospital
RECRUITING
Sheffield
Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust
NOT_YET_RECRUITING
Walsall
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 250
Treatments
Experimental: Ruxolitinib 0.75 % Cream
Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol.
Experimental: Ruxolitinib 1.5 % Cream
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Placebo_comparator: Vehicle Cream
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation