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Looking for participantsPhase3

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

Sponsor: Incyte Corporation

NCT ID: NCT06804811

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ruxolitinib Cream (drug), Vehicle Cream (drug)
How long the study runs
Study runs about 25 months (dates as stated)
About the drug or intervention
Ruxolitinib Cream — drug: Ruxolitinib cream applied topically to the affected area as a thin film twice daily. · Vehicle Cream — drug: Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
6 Years to 11 Years
Who
All
Number of participants
250
Started
2025-11-13
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for nonsegmental vitiligo
  • • Phase3 - 250 participants
  • • 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

Who can take part?

  • • Ages 6 Years to 11 Years
  • • Diagnosed with nonsegmental vitiligo

Where?

  • • London - The Royal London Hospital - Barts Health Nhs Trust
  • • London - Guys Hospital
  • • London - Great Ormond Street Hospital For Children Nhs Foundation Trust
  • • Sheffield - Sheffield Childrens Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

NonSegmental Vitiligo

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 6 Years - 11 Years
  • Who can join: All genders

What the study is looking for

  • ✓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, ≥...
  • ✓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.

Who cannot take part

  • ✗Diagnosis of other forms of vitiligo (eg, segmental).
  • ✗Any other skin disease that, in the opinion of the investigator, would interfere with the the study treatment application or...
  • ✗Prior or current use of depigmentation treatments (eg, monobenzone).
  • ✗Concurrent conditions and history of protocol-defined diseases
  • ✗Use of protocol-defined treatments within the indicated washout period before baseline.
See the full criteria
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.

Where Is This Study? (5 UK sites)

The Royal London Hospital - Barts Health Nhs Trust

London E1 1FR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Guys Hospital

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Great Ormond Street Hospital For Children Nhs Foundation Trust

London WC1N 3JH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: Research.Governance@gosh.nhs.uk

Research.Governance@gosh.nhs.uk0207 905 2700

Sheffield Childrens Hospital

Sheffield S10 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust

Walsall WS2 9PS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Marie Lewis

Walsall.research1@nhs.net01922 721172

How to Get in Touch

Incyte Corporation Call Center (US)

Sponsor contact

CONTACT

1.855.463.3463 medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

Sponsor contact

CONTACT

+800 00027423 eumedinfo@incyte.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10