Summary

Eligibility
for people ages 2-11 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

Description

Summary

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

Official Title

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Keywords

NonSegmental Vitiligo, pediatric, Ruxolitinib Cream, Vehicle Cream, Ruxolitinib 1.5 % Cream

Eligibility

You can join if…

Open to people ages 2-11

  • 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.

You CAN'T join 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).
  • 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.

Locations

  • University of California Irvine accepting new patients
    Irvine 5359777 California 5332921 92697 United States
  • Vitiligo & Pigmentation Institute of Southern California not yet accepting patients
    Los Angeles 5368361 California 5332921 90036-5609 United States
  • Dermatology Research Associates accepting new patients
    Los Angeles 5368361 California 5332921 90045 United States
  • Rady Children'S Hospital-San Diego accepting new patients
    San Diego 5391811 California 5332921 92123 United States
  • Axon Clinical Research accepting new patients
    Inglewood 5359488 California 5332921 90301 United States
  • La Universal Research Center, Inc accepting new patients
    Los Angeles 5368361 California 5332921 90057 United States
  • Dermatology Associates accepting new patients
    Encinitas 5346646 California 5332921 92024 United States
  • Integrative Skin Science and Research not yet accepting patients
    Sacramento 5389489 California 5332921 95815 United States
  • Peninsula Research Associates Pra accepting new patients
    Rolling Hills Estates 5388601 California 5332921 90274-7604 United States
  • Stanford School of Medicine accepting new patients
    Palo Alto 5380748 California 5332921 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
ID
NCT06548360
Phase
Phase 3 Vitiligo Research Study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated