A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Description

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

Conditions

NonSegmental Vitiligo

Study Overview

Study Details

Study overview

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

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

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Condition
NonSegmental Vitiligo
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Affiliated Dermatology, Scottsdale, Arizona, United States, 85255

Tucson

Banner - University Medicine Multispecialty Services Clinic, Tucson, Arizona, United States, 85718

Irvine

University of California Irvine, Irvine, California, United States, 92697

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

Los Angeles

La Universal Research Center, Inc, Los Angeles, California, United States, 90057

Palo Alto

Stanford School of Medicine, Palo Alto, California, United States, 94304

Pomona

Empire Clinical Research, Pomona, California, United States, 91767

Rolling Hills Estates

Peninsula Research Associates Pra, Rolling Hills Estates, California, United States, 90274-7604

Sacramento

Integrative Skin Science and Research, Sacramento, California, United States, 95815

San Diego

Rady Children'S Hospital-San Diego, San Diego, California, United States, 92123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

2 Years to 11 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2027-03-13