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

December 16, 2025 updated by: Incyte Corporation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

  • Name: Incyte Corporation Call Center (ex-US)
  • Phone Number: +800 00027423
  • Email: eumedinfo@incyte.com

Study Locations

  • Canada
      • St. John's, Canada, A1E 1V4
        • Recruiting
        • Skincare Studio Dermatology Centre
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Not yet recruiting
        • Dermatology Research Institute
      • Calgary, Alberta, Canada, T3B 6A8
        • Not yet recruiting
        • Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)
      • Calgary, Alberta, Canada, T2G 1B1
        • Recruiting
        • Kirk Barber Research
      • Edmonton, Alberta, Canada, T6G 1C3
        • Recruiting
        • Alberta Dermasurgery Centre
      • Edmonton, Alberta, Canada, T5J 3S9
        • Recruiting
        • Laser Rejuvenation Clinics Edmonton D.T. Inc
    • British Columbia
      • Vancouver, British Columbia, Canada, V6C 0C3
        • Recruiting
        • Coal Harbour Rejuvenation Dermatology, Inc.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1T6
        • Recruiting
        • Winnipeg Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K5R3
        • Recruiting
        • Maritime Dermatology
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Withdrawn
        • Childrens Hospital of Eastern Ontario
      • Ottawa, Ontario, Canada, K2T 0N7
        • Recruiting
        • Dar Clinical Research Inc
      • Toronto, Ontario, Canada, M5G1X8
        • Not yet recruiting
        • University of Toronto - the Hospital For Sick Children (Sickkids)
      • Toronto, Ontario, Canada, M5M 3Z8
        • Withdrawn
        • Dermatelier on Avenue
      • Toronto, Ontario, Canada, M5S 3B4
        • Recruiting
        • Cosmetic Dermatology on Bloor
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Not yet recruiting
        • Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche
      • Montreal, Quebec, Canada, H1Y 3L1
        • Recruiting
        • Centre de Recherche St-Louis
      • Québec, Quebec, Canada, G1W 4R4
        • Recruiting
        • Centre de Recherche Saint-Louis
      • Québec, Quebec, Canada, G1V 4G2
        • Recruiting
        • Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7T 0G3
        • Recruiting
        • Saskatoon Dermatology Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama At Birmingham-School of Medicine
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
      • Phoenix, Arizona, United States, 85037
        • Not yet recruiting
        • Omni Dermatology
      • Scottsdale, Arizona, United States, 85255
        • Completed
        • Affiliated Dermatology
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Banner - University Medicine Multispecialty Services Clinic
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Premier Dermatology Clinical Trials Institute At Northwest Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • Burke Pharmaceutical Research
    • California
      • Inglewood, California, United States, 90301
        • Recruiting
        • Axon Clinical Research
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California Irvine
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
      • Los Angeles, California, United States, 90036-5609
        • Recruiting
        • Vitiligo & Pigmentation Institute of Southern California
      • Los Angeles, California, United States, 90057
        • Recruiting
        • La Universal Research Center, Inc
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford School of Medicine
      • Pomona, California, United States, 91767
        • Recruiting
        • Empire Clinical Research
      • Rocklin, California, United States, 95765
        • Not yet recruiting
        • NorCal Clinical Research
      • Rolling Hills Estates, California, United States, 90274-7604
        • Completed
        • Peninsula Research Associates Pra
      • Sacramento, California, United States, 95815
        • Not yet recruiting
        • Integrative Skin Science and Research
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital-San Diego
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Recruiting
        • Paradigm Clinical Research Centers, Inc.
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Skin Care Research, LLC
      • Boynton Beach, Florida, United States, 33436
        • Recruiting
        • Encore Medical Research, Llc Boynton Beach
      • Hollywood, Florida, United States, 33201
        • Recruiting
        • Skin Care Research, LLC
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Solutions Through Advanced Research, Inc
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital
      • Miami, Florida, United States, 33146
        • Recruiting
        • Pediatric Skin Research Llc
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Dh Tamarac Research Center Etna Medical Center Emc
      • Tampa, Florida, United States, 33612
        • Recruiting
        • USF Health Morsani Center For Advanced Healthcare
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Emory University
      • Cumming, Georgia, United States, 30040
        • Recruiting
        • Cleaver Medical Group
      • Sandy Springs, Georgia, United States, 30328
        • Recruiting
        • Advanced Medical Research PC
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60602
        • Recruiting
        • Illinois Dermatology Institute the Chicago Loop
      • Libertyville, Illinois, United States, 60048
        • Not yet recruiting
        • Forefront Dermatology
      • Lincolnshire, Illinois, United States, 60069-4344
        • Withdrawn
        • Advanced Dermatology Lincolnshire
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Northshore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Completed
        • Wellskin Dermatology & Aesthetics
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University Health Sciences Center
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Dermatology Associates Pc
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Brighton, Massachusetts, United States, 02135-3511
        • Completed
        • Metro Boston Clinical Partners
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Withdrawn
        • Michigan Center for Research Company
      • Northville, Michigan, United States, 48167
        • Not yet recruiting
        • Mi Skin Center, Pllc
      • Waterford, Michigan, United States, 48328
        • Not yet recruiting
        • Michigan Dermatology Institute
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Completed
        • MediSearch Clinical Trials
    • Montana
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists Pc the Advanced Skin Research Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • The University of New Mexico Unm Health Sciences Center Hsc
    • New York
      • Brooklyn, New York, United States, 11203
        • Recruiting
        • SUNY Downstate Medical Center
      • New York, New York, United States, 10023
        • Recruiting
        • Equity Medical, LLC
      • New York, New York, United States, 10028-3135
        • Recruiting
        • Mount Sinai Doctors
      • New York, New York, United States, 10012
        • Recruiting
        • The Dermatology Specialists Greenwich
      • New York, New York, United States, 10075
        • Completed
        • Sadick Dermatology Sadick Research Group
      • Rochester, New York, United States, 14623
        • Recruiting
        • Skin Search of Rochester
      • Woodbury, New York, United States, 11797
        • Not yet recruiting
        • Vitality Clinical Research Llc
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Red River Research Partners
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Withdrawn
        • Dermatologists of Southwestern Ohio, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29212
        • Recruiting
        • Columbia Dermatology
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Completed
        • International Clinical Research Tennessee Llc
    • Texas
      • Austin, Texas, United States, 78723
        • Not yet recruiting
        • Dell Children's Medical Group
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • The University of Texas Health Science Center at Houston
      • Carrollton, Texas, United States, 75010
        • Not yet recruiting
        • DFW Clinical Trials
      • El Paso, Texas, United States, 79902
        • Recruiting
        • 3A Research Llc West Location
      • Frisco, Texas, United States, 75033
        • Recruiting
        • Reveal Research Institute
      • Grapevine, Texas, United States, 07605
        • Recruiting
        • ACRC Trials
      • Longview, Texas, United States, 75601
        • Recruiting
        • Us Dermatology Partners Longview
      • San Antonio, Texas, United States, 78218
        • Recruiting
        • Texas Dermatology and Laser Specialists
      • Southlake, Texas, United States, 76092
        • Not yet recruiting
        • Stryde Research
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • University of Utah MidValley Dermatology
      • South Jordan, Utah, United States, 84095
        • Recruiting
        • Jordan Valley Dermatology Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Withdrawn
        • Virginia Clinical Research, Inc Vcr Pariser Dermatology Specialists, Ltd Norfolk Location
    • Washington
      • Mill Creek, Washington, United States, 98012
        • Recruiting
        • Frontier Dermatology
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Dermatology Specialists of Spokane
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Not yet recruiting
        • University of Wisconsin School of Medicine
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion 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.

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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ruxolitinib 1.5 % Cream
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Drug: Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Other Names:
  • INCB018424 Phosphate Cream
Placebo Comparator: Vehicle Cream
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Drug: Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
Time Frame: Week 24
≥75% improvement in facial Vitiligo Area Scoring Index.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
Time Frame: Week 24
≥50% improvement in facial Vitiligo Area Scoring Index.
Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
Time Frame: Week 24
≥90% improvement in facial Vitiligo Area Scoring Index.
Week 24
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
Time Frame: Week 24
≥50% improvement in total body Vitiligo Area Scoring Index.
Week 24
Percentage change from baseline in F-BSA
Time Frame: Week 24
Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Week 24
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 52 and 30 days
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Up to Week 52 and 30 days
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
Time Frame: Week 52
≥50% improvement in facial Vitiligo Area Scoring Index.
Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
Time Frame: Week 52
≥75% improvement in facial Vitiligo Area Scoring Index.
Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
Time Frame: Week 52
≥90% improvement in facial Vitiligo Area Scoring Index.
Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
Time Frame: Week 52
≥50% improvement in total body Vitiligo Area Scoring Index.
Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)
Time Frame: Week 24 and Week 52
≥25% improvement in total body Vitiligo Area Scoring Index.
Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
Time Frame: Week 24 and Week 52
≥75% improvement in total body Vitiligo Area Scoring Index
Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)
Time Frame: Week 24 and Week 52
≥90% improvement in total body Vitiligo Area Scoring Index
Week 24 and Week 52
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
Time Frame: Weeks 6, 24, 30 and 52
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Weeks 6, 24, 30 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

January 24, 2025

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

March 13, 2027

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB18424-312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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