RECRUITING

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

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Conditions

NonSegmental Vitiligopediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-12-16
Study Completion:2027-03-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06548360

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.

Ages Eligible for Study:2 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Total body vitiligo area does not exceed 10% BSA.
  3. * Pigmented hair within some of the areas of vitiligo on the face.
  4. * Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.
  5. * 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.
  1. * Diagnosis of other forms of vitiligo (eg, segmental).
  2. * 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).
  3. * Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
  4. * Prior or current use of depigmentation treatments (eg, monobenzone).
  5. * 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.
  6. * Use of protocol-defined treatments within the indicated washout period before baseline.
  7. * Current or previous use of JAK inhibitors, systemic or topical.
  8. * Protocol-defined clinically significant abnormal laboratory values at screening.
  9. * BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
  10. * Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
  11. * In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.
  12. * Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
  13. * Employees of the sponsor or investigator or are otherwise dependents of them.
  14. * Known allergy or reaction to any component of the study cream formulation.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com
Incyte Corporation Call Center (ex-US)
CONTACT
+800 00027423
eumedinfo@incyte.com

Principal Investigator

Incyte Medical Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

Affiliated Dermatology
Scottsdale, Arizona, 85255
United States
Banner - University Medicine Multispecialty Services Clinic
Tucson, Arizona, 85718
United States
University of California Irvine
Irvine, California, 92697
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
La Universal Research Center, Inc
Los Angeles, California, 90057
United States
Stanford School of Medicine
Palo Alto, California, 94304
United States
Empire Clinical Research
Pomona, California, 91767
United States
Peninsula Research Associates Pra
Rolling Hills Estates, California, 90274-7604
United States
Integrative Skin Science and Research
Sacramento, California, 95815
United States
Rady Children'S Hospital-San Diego
San Diego, California, 92123
United States
Paradigm Clinical Research Centers, Inc.
Wheat Ridge, Colorado, 80033
United States
Skin Care Research, Llc
Boca Raton, Florida, 33486
United States
Pediatric Skin Research Llc
Coral Gables, Florida, 33146
United States
Solutions Through Advanced Research, Inc
Jacksonville, Florida, 32256
United States
Dh Tamarac Research Center Etna Medical Center Emc
Tamarac, Florida, 33321
United States
Cleaver Medical Group
Cumming, Georgia, 30040
United States
Advanced Medical Research Pc
Sandy Springs, Georgia, 30328
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
Illinois Dermatology Institute the Chicago Loop
Chicago, Illinois, 60602
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Northshore University Healthsystem
Skokie, Illinois, 60077
United States
Wellskin Dermatology & Aesthetics
Bowling Green, Kentucky, 42104
United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135-3511
United States
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
United States
Boeson Research
Missoula, Montana, 59804
United States
Activmed Practices & Research Inc
Portsmouth, New Hampshire, 03801
United States
Suny Downstate Medical Center
Brooklyn, New York, 11203
United States
Icahn School of Medicine At Mount Sinai
New York, New York, 10003
United States
Sadick Dermatology Sadick Research Group
New York, New York, 10075
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
United States
Dell Children'S Medical Group
Austin, Texas, 78723
United States
The University of Texas Health Science Center At Houston
Bellaire, Texas, 77401
United States
Pediatric Dermatology of North Texas
Grapevine, Texas, 76051
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
United States
University of Utah Midvalley Dermatology
Murray, Utah, 84107
United States
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
United States
Pi Coor Clinical Research Llc
Burke, Virginia, 22015
United States
Frontier Dermatology
Mill Creek, Washington, 98012
United States
Seattle Children'S Hospital
Seattle, Washington, 98105
United States
Dermatology Specialists of Spokane
Spokane, Washington, 99202
United States
University of Wisconsin School of Medicine
Madison, Wisconsin, 53715
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2027-03-13

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2027-03-13

Terms related to this study

Keywords Provided by Researchers

  • NonSegmental Vitiligo
  • pediatric

Additional Relevant MeSH Terms

  • NonSegmental Vitiligo