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

Recruiting now · Phase 3

Conditions studied: NonSegmental Vitiligo

In brief

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.

Key facts

Study ID

NCT06804811

Run by

Incyte Corporation

People needed

250

Starts

2025-11-13

Expected to finish

2027-12-01

Last updated by the study team

2026-07-22

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina (enrolling)
• Instituto de Neumonologia Y Dermatologia — Buenos Aires, Argentina (enrolling)
• Consultorios Medicos Dr. Doreski — Buenos Aires, Argentina (enrolling)
• Derma Internacional S.A. — Buenos Aires, Argentina (enrolling)
• Hospital Universitario Austral — Derqui-pilar, Argentina (enrolling)
• Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Argentina (enrolling)
• Hospital Del Nino Jesus — San Miguel de Tucumán, Argentina (enrolling)
• Universitaetsklinikum Graz — Graz, Austria (enrolling)
• Medical University Innsbruck — Innsbruck, Austria (enrolling)
• Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel) — Brussels, Belgium (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• Universitair Ziekenhuis Leuven — Leuven, Belgium (enrolling)
• Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Belgium (enrolling)
• Medical Center Asklepii Ood — Dupnitsa, Bulgaria (enrolling)
• Mhat Dr. Tota Venkova Ad — Gabrovo, Bulgaria (enrolling)
• Medical Center Unimed Eood — Sevlievo, Bulgaria (enrolling)
• Umhat Aleksandrovska — Sofia, Bulgaria (enrolling)
• 28 Diagnostic and Consultative Center — Sofia, Bulgaria (enrolling)
• Mc Euroderma Clinic — Sofia, Bulgaria (enrolling)
• Diagnostic Consultation Center Xx - Sofia Eood — Sofia, Bulgaria (enrolling)
• Herlev and Gentofte Hospital — Hellerup, Denmark (enrolling)
• Sanos Clinic — Herlev, Denmark (enrolling)
• Centre Hospitalier Victor Dupouy — Argenteuil, France (enrolling)
• Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux, France (enrolling)
• Psoriahue — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.