Ruxolitinib Cream: Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream: Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Study 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
Sex
ALL
Min age
6 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Diagnosis of other forms of vitiligo (eg, segmental).
* Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
* Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
* Prior or current use of depigmentation treatments (eg, monobenzone).
* Concurrent conditions and history of protocol-defined diseases
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Use of protocol-defined treatments within the indicated washout period before baseline.
* History of treatment failure with any systemic or topical JAK inhibitor for vitiligo or any other inflammatory condition.
* Protocol-defined clinically significant abnormal laboratory values at screening.
* BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
* Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
* In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.
* Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
* Employees of the sponsor or investigator or are otherwise dependents of them.
* Known allergy or reaction to any component of the study cream formulation.
* The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health code.
* In the EU, participants considered incapacitated according to EU CTR No. 536/2014 Articles 2 and 31.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Primary outcome measure(s)
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) — Week 24 ≥75% improvement in facial Vitiligo Area Scoring Index.
Trial sites (79)
Facility
City
Region
Status
Psoriahue
Buenos Aires
Argentina
Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires
Argentina
Recruiting
Instituto de Neumonologia Y Dermatologia
Buenos Aires
Argentina
Recruiting
Consultorios Medicos Dr. Doreski
Buenos Aires
Argentina
Recruiting
Derma Internacional S.A.
Buenos Aires
Argentina
Recruiting
Hospital Universitario Austral
Derqui-pilar
Argentina
Recruiting
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata
Argentina
Recruiting
Hospital Del Nino Jesus
San Miguel de Tucumán
Argentina
Recruiting
Universitaetsklinikum Graz
Graz
Austria
Recruiting
Medical University Innsbruck
Innsbruck
Austria
Recruiting
Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
Brussels
Belgium
Recruiting
Universitair Ziekenhuis Gent
Ghent
Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven
Belgium
Recruiting
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert
Belgium
Recruiting
Medical Center Asklepii Ood
Dupnitsa
Bulgaria
Recruiting
Mhat Dr. Tota Venkova Ad
Gabrovo
Bulgaria
Recruiting
Medical Center Unimed Eood
Sevlievo
Bulgaria
Recruiting
Umhat Aleksandrovska
Sofia
Bulgaria
Recruiting
28 Diagnostic and Consultative Center
Sofia
Bulgaria
Recruiting
Mc Euroderma Clinic
Sofia
Bulgaria
Recruiting
Diagnostic Consultation Center Xx - Sofia Eood
Sofia
Bulgaria
Recruiting
Herlev and Gentofte Hospital
Hellerup
Denmark
Recruiting
Sanos Clinic
Herlev
Denmark
Recruiting
Centre Hospitalier Victor Dupouy
Argenteuil
France
Recruiting
Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux
France
Recruiting
Centre Hospitalier Intercommunal de Creteil
Créteil
France
Recruiting
Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)
Lyon
France
Recruiting
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
Nantes
France
Recruiting
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice
France
Recruiting
Hopital Universitaire Necker Enfants Malades
Paris
France
Recruiting
Polyclinique de Courlancy
Reims
France
Not Yet Recruiting
Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey
Toulouse
France
Recruiting
Chu Nancy
Vandœuvre-lès-Nancy
France
Recruiting
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)
Berlin
Germany
Recruiting
Hautklinik Universitatsklinikum Erlangen
Erlangen
Germany
Recruiting
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg
Germany
Recruiting
University Medical Center Schleswig-Holstein
Kiel
Germany
Recruiting
Universitaetsklinikum Leipzig
Leipzig
Germany
Recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz
Germany
Recruiting
Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)
München
Germany
Recruiting
+ 39 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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