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

NCT06548360 | Recruiting Phase 3 FDA Drug

• 1 other identifier: INCB18424-312
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 99

Brief Summary

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

Keywords

NonSegmental Vitiligo; pediatric

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)

  ≥75% improvement in facial Vitiligo Area Scoring Index.

  Week 24

Secondary Outcomes (13)

• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

  Week 24

• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)

  Week 24

• Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)

  Week 24

• Percentage change from baseline in F-BSA

  Week 24

• Number of Treatment Emergent Adverse Events (TEAEs)

  Up to Week 52 and 30 days

Study Arms (2)

Ruxolitinib 1.5 % Cream

EXPERIMENTAL

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Drug: Ruxolitinib Cream

Vehicle Cream

PLACEBO COMPARATOR

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Drug: Vehicle Cream

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Also known as: INCB018424 Phosphate Cream

Ruxolitinib 1.5 % Cream

Vehicle Cream DRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Vehicle Cream

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (99)

University of Alabama At Birmingham-School of Medicine

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

Phoenix Children'S Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Omni Dermatology

Phoenix, Arizona, 85037, United States

NOT YET RECRUITING

Affiliated Dermatology

Scottsdale, Arizona, 85255, United States

COMPLETED

Banner - University Medicine Multispecialty Services Clinic

Tucson, Arizona, 85718, United States

RECRUITING

Premier Dermatology Clinical Trials Institute At Northwest Arkansas

Fayetteville, Arkansas, 72703, United States

RECRUITING

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

RECRUITING

Axon Clinical Research

Inglewood, California, 90301, United States

RECRUITING

University of California Irvine

Irvine, California, 92697, United States

RECRUITING

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036-5609, United States

RECRUITING

Dermatology Research Associates

Los Angeles, California, 90045, United States

RECRUITING

La Universal Research Center, Inc

Los Angeles, California, 90057, United States

RECRUITING

Stanford School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

Empire Clinical Research

Pomona, California, 91767, United States

RECRUITING

Norcal Clinical Research

Rocklin, California, 95765, United States

NOT YET RECRUITING

Peninsula Research Associates Pra

Rolling Hills Estates, California, 90274-7604, United States

COMPLETED

Integrative Skin Science and Research

Sacramento, California, 95815, United States

NOT YET RECRUITING

Rady Children'S Hospital-San Diego

San Diego, California, 92123, United States

RECRUITING

Children'S Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Paradigm Clinical Research Centers, Inc.

Wheat Ridge, Colorado, 80033, United States

RECRUITING

Skin Care Research, Llc

Boca Raton, Florida, 33486, United States

RECRUITING

Encore Medical Research, Llc Boynton Beach

Boynton Beach, Florida, 33436, United States

RECRUITING

Skin Care Research, Llc

Hollywood, Florida, 33201, United States

RECRUITING

Solutions Through Advanced Research, Inc

Jacksonville, Florida, 32256, United States

RECRUITING

Pediatric Skin Research Llc

Miami, Florida, 33146, United States

RECRUITING

Nicklaus Children'S Hospital

Miami, Florida, 33155, United States

RECRUITING

Dh Tamarac Research Center Etna Medical Center Emc

Tamarac, Florida, 33321, United States

RECRUITING

Usf Health Morsani Center For Advanced Healthcare

Tampa, Florida, 33612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Cleaver Medical Group

Cumming, Georgia, 30040, United States

RECRUITING

Advanced Medical Research Pc

Sandy Springs, Georgia, 30328, United States

RECRUITING

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

RECRUITING

Illinois Dermatology Institute the Chicago Loop

Chicago, Illinois, 60602, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Forefront Dermatology

Libertyville, Illinois, 60048, United States

NOT YET RECRUITING

Advanced Dermatology Lincolnshire

Lincolnshire, Illinois, 60069-4344, United States

WITHDRAWN

Northshore University Healthsystem

Skokie, Illinois, 60077, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

Wellskin Dermatology & Aesthetics

Bowling Green, Kentucky, 42104, United States

COMPLETED

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Dermatology Associates Pc

Rockville, Maryland, 20850, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135-3511, United States

COMPLETED

Michigan Center For Research Company

Clarkston, Michigan, 48346, United States

WITHDRAWN

Mi Skin Center, Pllc

Northville, Michigan, 48167, United States

NOT YET RECRUITING

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

NOT YET RECRUITING

Medisearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

COMPLETED

Boeson Research

Missoula, Montana, 59804, United States

RECRUITING

Skin Specialists Pc the Advanced Skin Research Center

Omaha, Nebraska, 68144, United States

RECRUITING

The University of New Mexico Unm Health Sciences Center Hsc

Albuquerque, New Mexico, 87102, United States

RECRUITING

Suny Downstate Medical Center

Brooklyn, New York, 11203, United States

RECRUITING

The Dermatology Specialists Greenwich

New York, New York, 10012, United States

RECRUITING

Equity Medical, Llc

New York, New York, 10023, United States

RECRUITING

Mount Sinai Doctors

New York, New York, 10028-3135, United States

RECRUITING

Sadick Dermatology Sadick Research Group

New York, New York, 10075, United States

COMPLETED

Skin Search of Rochester

Rochester, New York, 14623, United States

RECRUITING

Vitality Clinical Research Llc

Woodbury, New York, 11797, United States

NOT YET RECRUITING

Red River Research Partners

Fargo, North Dakota, 58103, United States

RECRUITING

Dermatologists of Southwestern Ohio, Llc

Bexley, Ohio, 43209, United States

WITHDRAWN

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Columbia Dermatology

Columbia, South Carolina, 29212, United States

RECRUITING

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

COMPLETED

Dell Children'S Medical Group

Austin, Texas, 78723, United States

NOT YET RECRUITING

The University of Texas Health Science Center At Houston

Bellaire, Texas, 77401, United States

RECRUITING

Dfw Clinical Trials

Carrollton, Texas, 75010, United States

NOT YET RECRUITING

3A Research Llc West Location

El Paso, Texas, 79902, United States

RECRUITING

Reveal Research Institute

Frisco, Texas, 75033, United States

RECRUITING

Acrc Trials

Grapevine, Texas, 07605, United States

RECRUITING

Us Dermatology Partners Longview

Longview, Texas, 75601, United States

RECRUITING

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

RECRUITING

Stryde Research

Southlake, Texas, 76092, United States

NOT YET RECRUITING

University of Utah Midvalley Dermatology

Murray, Utah, 84107, United States

RECRUITING

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

RECRUITING

Virginia Clinical Research, Inc Vcr Pariser Dermatology Specialists, Ltd Norfolk Location

Norfolk, Virginia, 23502, United States

WITHDRAWN

Frontier Dermatology

Mill Creek, Washington, 98012, United States

RECRUITING

Seattle Children'S Hospital

Seattle, Washington, 98105, United States

RECRUITING

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

RECRUITING

University of Wisconsin School of Medicine

Madison, Wisconsin, 53715, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

RECRUITING

Dermatology Research Institute

Calgary, Alberta, T2J 7E1, Canada

NOT YET RECRUITING

Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)

Calgary, Alberta, T3B 6A8, Canada

NOT YET RECRUITING

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta, T5J 3S9, Canada

RECRUITING

Alberta Dermasurgery Centre

Edmonton, Alberta, T6G 1C3, Canada

RECRUITING

Coal Harbour Rejuvenation Dermatology, Inc.

Vancouver, British Columbia, V6C 0C3, Canada

RECRUITING

Winnipeg Clinic

Winnipeg, Manitoba, R3C 1T6, Canada

RECRUITING

Maritime Dermatology

Halifax, Nova Scotia, B3K5R3, Canada

RECRUITING

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

WITHDRAWN

Dar Clinical Research Inc

Ottawa, Ontario, K2T 0N7, Canada

RECRUITING

University of Toronto - the Hospital For Sick Children (Sickkids)

Toronto, Ontario, M5G1X8, Canada

NOT YET RECRUITING

Dermatelier on Avenue

Toronto, Ontario, M5M 3Z8, Canada

WITHDRAWN

Cosmetic Dermatology on Bloor

Toronto, Ontario, M5S 3B4, Canada

RECRUITING

Centre de Recherche St-Louis

Montreal, Quebec, H1Y 3L1, Canada

RECRUITING

Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)

Québec, Quebec, G1V 4G2, Canada

RECRUITING

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

RECRUITING

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, S7T 0G3, Canada

RECRUITING

Skincare Studio Dermatology Centre

St. John's, A1E 1V4, Canada

RECRUITING

Related Links

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

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: January 24, 2025
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): March 13, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

US (80); CA (19)