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

July 21, 2026 updated by: Incyte Corporation

A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentina, C1425BEA
        • Recruiting
        • Instituto de Neumonologia y Dermatologia
      • Buenos Aires, Argentina, 01425
        • Recruiting
        • Psoriahue
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Consultorios Médicos Dr. Doreski
      • Buenos Aires, Argentina, C1426
        • Recruiting
        • Derma Internacional S.A.
      • Derqui-pilar, Argentina, B16290DT
        • Recruiting
        • Hospital Universitario Austral
      • Mar del Plata, Argentina, B7600FYK
        • Recruiting
        • Centro de Investigaciones Medicas Mar Del Plata
      • San Miguel de Tucumán, Argentina, 04000
        • Recruiting
        • Hospital del Nino Jesus
  • Austria
      • Graz, Austria, 08036
        • Recruiting
        • Universitaetsklinikum Graz
      • Innsbruck, Austria, 06020
        • Recruiting
        • Medical University Innsbruck
  • Belgium
      • Brussels, Belgium, 01070
        • Recruiting
        • Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
      • Ghent, Belgium, 09000
        • Recruiting
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 03000
        • Recruiting
        • Universitair Ziekenhuis Leuven
      • Woluwe-Saint-Lambert, Belgium, 01200
        • Recruiting
        • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
  • Bulgaria
      • Dupnitsa, Bulgaria, 02600
        • Recruiting
        • Medical Center Asklepii OOD
      • Gabrovo, Bulgaria, 05300
        • Recruiting
        • Mhat Dr. Tota Venkova Ad
      • Sevlievo, Bulgaria, 05400
        • Recruiting
        • Medical Center Unimed Eood
      • Sofia, Bulgaria, 01528
        • Recruiting
        • 28 Diagnostic and Consultative Center
      • Sofia, Bulgaria, 01606
        • Recruiting
        • Mc Euroderma Clinic
      • Sofia, Bulgaria, 01618
        • Recruiting
        • Diagnostic Consultation Center Xx - Sofia Eood
      • Sofia, Bulgaria, 01431
        • Recruiting
        • UMHAT Aleksandrovska
  • Denmark
      • Hellerup, Denmark, 02900
        • Recruiting
        • Herlev and Gentofte Hospital
      • Herlev, Denmark, 02730
        • Recruiting
        • Sanos Clinic
  • France
      • Argenteuil, France, 95107
        • Recruiting
        • Centre Hospitalier Victor Dupouy
      • Bordeaux, France, 33076
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
      • Créteil, France, 75571
        • Recruiting
        • Centre Hospitalier Intercommunal de Créteil
      • Lyon, France, 69003
        • Recruiting
        • Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)
      • Nantes, France, 44093
        • Recruiting
        • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
      • Nice, France, 06200
        • Recruiting
        • Centre Hospitalier Universitaire de Nice,Hopital L Archet
      • Paris, France, 75015
        • Recruiting
        • Hopital Universitaire Necker Enfants Malades
      • Reims, France, 51100
        • Not yet recruiting
        • Polyclinique de Courlancy
      • Toulouse, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Larrey
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • Chu Nancy
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)
      • Erlangen, Germany, 91054
        • Recruiting
        • Hautklinik Universitatsklinikum Erlangen
      • Hamburg, Germany, 22149
        • Recruiting
        • Katholisches Kinderkrankenhaus Wilhelmstift
      • Kiel, Germany, 24105
        • Recruiting
        • University Medical Center Schleswig-Holstein
      • Leipzig, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig
      • Mainz, Germany, 55131
        • Recruiting
        • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
      • München, Germany, 81675
        • Recruiting
        • Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)
      • Münster, Germany, 48149
        • Recruiting
        • University hospital Muenster
  • Hungary
      • Budapest, Hungary, 01033
        • Recruiting
        • Clinexpert
      • Debrecen, Hungary, 04032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
      • Pécs, Hungary, 07632
        • Recruiting
        • University of Pecs-Clinical Center
      • Szeged, Hungary, 06720
        • Recruiting
        • University of Szeged
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna
      • Brescia, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
      • Catania, Italy, 95123
        • Recruiting
        • Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
      • Milan, Italy, 20122
        • Recruiting
        • Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliero Universitaria Federico II di Napoli
      • Padua, Italy, 35100
        • Recruiting
        • Azienda Ospedale Universita Di Padova
      • Roma, Italy, 00167
        • Recruiting
        • Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
      • Rome, Italy, 00137
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Rome, Italy, 00165
        • Not yet recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesu
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Amsterdam Umc Research Bv
  • Poland
      • Gdansk, Poland, 80-546
        • Recruiting
        • Centrum Badań Klinicznych PI-House sp. z o.o.
      • Katowice, Poland, 40-568
        • Recruiting
        • Care Clinic Sp. Z O.O.
      • Krakow, Poland, 31-559
        • Recruiting
        • Diamond Clinic Specjalistyczne Poradnie Lekarskie
      • Lublin, Poland, 20-607
        • Recruiting
        • DERMEDIC Iwona Zdybska
      • Nowa Sól, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia - Medyczne Nowa Sol
      • Osielsko, Poland, 86-031
        • Recruiting
        • Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski
      • Rzeszów, Poland, 35-055
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
      • Szczecin, Poland, 71-500
        • Recruiting
        • Twoja Przychodnia SCM
      • Warsaw, Poland, 02-625
        • Recruiting
        • Evimed Sp. Z O. O.
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Centro Hospitalar E Universitario Coimbra
      • Lisbon, Portugal, 1169-050
        • Recruiting
        • Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos
      • Porto, Portugal, 4099-001
        • Recruiting
        • Hospital Geral de Santo Antonio
  • Spain
      • Alcorcón, Spain, 28922
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital de La Santa Creu I Sant Pau
      • Esplugues de Llobregat, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Déu Barcelona
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Unversitario Nino Jesus
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet de Zaragoza
  • United Kingdom
      • Croydon, United Kingdom, CR7 7YE
        • Not yet recruiting
        • Croydon University Hospital
      • London, United Kingdom, SE1 9RT
        • Not yet recruiting
        • Guys Hospital
      • London, United Kingdom, WC1N 3JH
        • Not yet recruiting
        • Great Ormond Street Hospital for Children NHS Foundation Trust
      • London, United Kingdom, E1 1FR
        • Recruiting
        • The Royal London Hospital - Barts Health Nhs Trust
      • Sheffield, United Kingdom, S10 2TH
        • Recruiting
        • Sheffield Childrens Hospital
      • Walsall, United Kingdom, WS2 9PS
        • Not yet recruiting
        • Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ruxolitinib 1.5 % Cream
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
  • INCB018424 Phosphate Cream
Placebo Comparator: Vehicle Cream
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Drug: Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Experimental: Ruxolitinib 0.75 % Cream
Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol.
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
  • INCB018424 Phosphate Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
Time Frame: Week 24
≥75% improvement in facial Vitiligo Area Scoring Index.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
Time Frame: Week 24
≥50% improvement in facial Vitiligo Area Scoring Index.
Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
Time Frame: Week 24
≥90% improvement in facial Vitiligo Area Scoring Index.
Week 24
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
Time Frame: Week 24
≥50% improvement in total body Vitiligo Area Scoring Index.
Week 24
Percentage change from baseline in F-BSA
Time Frame: Week 24
Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Week 24
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 52 and 30 days
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Up to Week 52 and 30 days
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
Time Frame: Weeks 6, 24, 30 and 52
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Weeks 6, 24, 30 and 52
Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable)
Time Frame: Week 24 and Week 52
The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale.
Week 24 and Week 52
Proportion of participants in each category for the color-matching question
Time Frame: Week 24 and Week 52
The color-matching question is a patient-reported measure of vitiligo treatment success that has a 5-point scale.
Week 24 and Week 52
Proportion of participants who report facial assessment of Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of very much improved or much improved
Time Frame: Week 24 and Week 52
The F-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale.
Week 24 and Week 52
Proportion of participants who report total body assessment of Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of very much improved or much improved
Time Frame: Week 24 and Week 52
The T-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale.
Week 24 and Week 52
Change from baseline in Psychosocial Impact Questionnaire for Pediatric Patients Who Have Nonsegmental Vitiligo (VIT-PIQ)
Time Frame: Week 24 and Week 52
The VIT-PIQ is a 17-item questionnaire to assess Quality of Life (QOL) of children with vitiligo.
Week 24 and Week 52
Change from baseline in Children's Dermatology Life Quality Index (CDLQI)
Time Frame: Week 24 and Week 52
The CDLQI is the youth/children's version of the Dermatology Life Quality Index.
Week 24 and Week 52
Change from baseline in Patient Global Impression of Bother - Vitiligo (PGIB-V)
Time Frame: Week 24 and Week 52
The PGIB-V is a single question with an 11-point scale ("not at all" to "a whole lot") to assess the participant's level of bother because of their vitiligo.
Week 24 and Week 52
Mean satisfaction score
Time Frame: Week 24 and Week 52
The treatment satisfaction tool is a fit-for-purpose questionnaire to assess treatment satisfaction in children with nonsegmental vitiligo.
Week 24 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB18424-309
  • 2024-513171-41-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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