Status:
RECRUITING
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Lead Sponsor:
Incyte Corporation
Conditions:
NonSegmental Vitiligo
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Eligibility Criteria
Inclusion
- 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 from screening through 30 days after the last application of study cream.
Exclusion
- 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).
- 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.
- Current or previous use of JAK inhibitors, systemic or topical.
- 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.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Key Trial Info
Start Date :
January 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 13 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06548360
Start Date
January 24 2025
End Date
March 13 2027
Last Update
December 18 2025
Active Locations (99)
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1
University of Alabama At Birmingham-School of Medicine
Birmingham, Alabama, United States, 35233
2
Phoenix Children'S Hospital
Phoenix, Arizona, United States, 85016
3
Omni Dermatology
Phoenix, Arizona, United States, 85037
4
Affiliated Dermatology
Scottsdale, Arizona, United States, 85255