NonSegmental VitiligoPhase 3NCT06804811
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
A Phase 3 study testing Ruxolitinib Cream in people with NonSegmental Vitiligo, run by Incyte Corporation at 78 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- NonSegmental Vitiligo
- What is being tested?
- Ruxolitinib Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 78 sitesin 14 countries
- Study dates
- 13 Nov 2025to 1 Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
78 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
78 sites in 14 countries
France10 sites, 10 recruiting
- Recruiting
Centre Hospitalier Victor Dupouy
Argenteuil, 95107
- Recruiting
Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
- Recruiting
Centre Hospitalier Intercommunal de Creteil
Créteil, 75571
- Recruiting
Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)
Lyon, 69003
- Recruiting
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
Nantes, 44093
- Recruiting
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, 06200
- Recruiting
Hopital Universitaire Necker Enfants Malades
Paris, 75015
- Recruiting
Polyclinique de Courlancy
Reims, 51100
- Recruiting
Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey
Toulouse, 31059
- Recruiting
Chu Nancy
Vandœuvre-lès-Nancy, 54500
Italy9 sites, 9 recruiting
- Recruiting
A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna
Bologna, 40138
- Recruiting
Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia
Brescia, 25123
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
Catania, 95123
- Recruiting
Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
Milan, 20122
- Recruiting
Azienda Ospedaliero Universitaria Federico Ii Di Napoli
Naples, 80131
- Recruiting
Azienda Ospedale Universita Di Padova
Padua, 35100
- Recruiting
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
Roma, 00167
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, 00137
- Recruiting
Irccs Ospedale Pediatrico Bambino Gesu
Rome, 00165
Poland9 sites, 9 recruiting
- Recruiting
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, 80-546
- Recruiting
Care Clinic Sp. Z O.O.
Katowice, 40-568
- Recruiting
Diamond Clinic Specjalistyczne Poradnie Lekarskie
Krakow, 31-559
- Recruiting
Dermedic Iwona Zdybska
Lublin, 20-607
- Recruiting
Twoja Przychodnia - Medyczne Nowa Sol
Nowa Sól, 67-100
- Recruiting
Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski
Osielsko, 86-031
- Recruiting
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów, 35-055
- Recruiting
Twoja Przychodnia Scm
Szczecin, 71-500
- Recruiting
Evimed Sp. Z O. O.
Warsaw, 02-625
Argentina8 sites, 8 recruiting
- Recruiting
Psoriahue
Buenos Aires, 01425
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
- Recruiting
Instituto de Neumonologia Y Dermatologia
Buenos Aires, C1425BEA
- Recruiting
Consultorios Medicos Dr. Doreski
Buenos Aires, C1426ABP
- Recruiting
Derma Internacional S.A.
Buenos Aires, C1426
- Recruiting
Hospital Universitario Austral
Derqui-pilar, B16290DT
- Recruiting
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK
- Recruiting
Hospital Del Nino Jesus
San Miguel de Tucumán, 04000
Germany8 sites, 8 recruiting
- Recruiting
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)
Berlin, 10117
- Recruiting
Hautklinik Universitatsklinikum Erlangen
Erlangen, 91054
- Recruiting
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg, 22149
- Recruiting
University Medical Center Schleswig-Holstein
Kiel, 24105
- Recruiting
Universitaetsklinikum Leipzig
Leipzig, 04103
- Recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131
- Recruiting
Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)
München, 81675
- Recruiting
University Hospital Muenster
Münster, 48149
Bulgaria7 sites, 7 recruiting
- Recruiting
Medical Center Asklepii Ood
Dupnitsa, 02600
- Recruiting
Mhat Dr. Tota Venkova Ad
Gabrovo, 05300
- Recruiting
Medical Center Unimed Eood
Sevlievo, 05400
- Recruiting
Umhat Aleksandrovska
Sofia, 01431
- Recruiting
28 Diagnostic and Consultative Center
Sofia, 01528
- Recruiting
Mc Euroderma Clinic
Sofia, 01606
- Recruiting
Diagnostic Consultation Center Xx - Sofia Eood
Sofia, 01618
Spain6 sites, 6 recruiting
- Recruiting
Hospital Universitario Fundacion Alcorcon
Alcorcón, 28922
- Recruiting
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
- Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona, 08026
- Recruiting
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, 08950
- Recruiting
Hospital Infantil Unversitario Nino Jesus
Madrid, 28009
- Recruiting
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, 50009
United Kingdom5 sites, 5 recruiting
- Recruiting
The Royal London Hospital - Barts Health Nhs Trust
London, E1 1FR
- Recruiting
Guys Hospital
London, SE1 9RT
- Recruiting
Great Ormond Street Hospital For Children Nhs Foundation Trust
London, WC1N 3JH
- Recruiting
Sheffield Childrens Hospital
Sheffield, S10 2TH
- Recruiting
Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust
Walsall, WS2 9PS
Belgium4 sites, 4 recruiting
- Recruiting
Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
Brussels, 01070
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 09000
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 03000
- Recruiting
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 01200
Hungary4 sites, 4 recruiting
- Recruiting
Clinexpert
Budapest, 01033
- Recruiting
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
Debrecen, 04032
- Recruiting
University of Pecs-Clinical Center
Pécs, 07632
- Recruiting
University of Szeged
Szeged, 06720
Portugal3 sites, 3 recruiting
- Recruiting
Centro Hospitalar E Universitario Coimbra
Coimbra, 3000-075
- Recruiting
Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos
Lisbon, 1169-050
- Recruiting
Hospital Geral de Santo Antonio
Porto, 4099-001
Austria2 sites, 2 recruiting
- Recruiting
Universitaetsklinikum Graz
Graz, 08036
- Recruiting
Medical University Innsbruck
Innsbruck, 06020
Denmark2 sites, 2 recruiting
- Recruiting
Herlev and Gentofte Hospital
Hellerup, 02900
- Recruiting
Sanos Clinic
Herlev, 02730
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam Umc Research Bv
Amsterdam, 1105 AZ
About this study
Official title: 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.
- Conditions
- NonSegmental Vitiligo
- Being tested
- Ruxolitinib Cream, Vehicle Cream
- Keywords
- NonSegmental Vitiligo, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib CreamDrug
Also called INCB018424 Phosphate Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle CreamDrug
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib 0.75 % Cream | Experimental | Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol. Receives: Drug: Ruxolitinib Cream |
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. Receives: Drug: Ruxolitinib Cream |
| Vehicle Cream | Placebo comparator | Participants received vehicle cream, applied topically to the affected area as defined by the protocol. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 24
Secondary outcomes (14)
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
≥50% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 24
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Measured: Week 24
Percentage change from baseline in F-BSA
Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Measured: Week 24
Number of Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to Week 52 and 30 days
Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable)
The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale.
Measured: Week 24 and Week 52
Proportion of participants in each category for the color-matching question
The color-matching question is a patient-reported measure of vitiligo treatment success that has a 5-point scale.
Measured: 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
The F-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale.
Measured: 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
The T-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale.
Measured: Week 24 and Week 52
Change from baseline in Psychosocial Impact Questionnaire for Pediatric Patients Who Have Nonsegmental Vitiligo (VIT-PIQ)
The VIT-PIQ is a 17-item questionnaire to assess Quality of Life (QOL) of children with vitiligo.
Measured: Week 24 and Week 52
Change from baseline in Children's Dermatology Life Quality Index (CDLQI)
The CDLQI is the youth/children's version of the Dermatology Life Quality Index.
Measured: Week 24 and Week 52
Change from baseline in Patient Global Impression of Bother - Vitiligo (PGIB-V)
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.
Measured: Week 24 and Week 52
Mean satisfaction score
The treatment satisfaction tool is a fit-for-purpose questionnaire to assess treatment satisfaction in children with nonsegmental vitiligo.
Measured: Week 24 and Week 52
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Measured: Weeks 6, 24, 30 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start13 Nov 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NonSegmental VitiligoStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804811
- Sponsor's protocol ID
- INCB18424-309
- Other IDs
- 2024-513171-41-00
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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