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Clinical Trials in the UK / NCT06804811
Recruiting Phase 3

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

NCT06804811 · tracked via the Priya Life Science UK tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2025-11-13
Last updated
2026-07-22

Condition(s) studied

NonSegmental Vitiligo

Investigational drug(s) / intervention(s)

Ruxolitinib CreamVehicle Cream

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)

Trial sites (79)

FacilityCityRegionStatus
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.

More Incyte Corporation trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT06804811 on ClinicalTrials.gov ↗ ← All trials in the UK