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NCT06548360PHASE3Recruiting

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

Incyte Corporation

Start Date

1/24/2025

Completion Date

3/13/2027

Summary

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

Eligibility Criteria

Age Range: 2 years to 11 years

Inclusion Criteria: * Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on nonfacial areas, ≥ 2 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. * History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition. * Protocol-defined clinically significant abnormal laboratory values at screening. * 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.

Interventions

DRUG

Ruxolitinib Cream

DRUG

Vehicle Cream

Interested in This Trial?

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Conditions

NonSegmental Vitiligo

Locations

University of Alabama At Birmingham-School of Medicine

Birmingham, Alabama 35233

United States

Saguaro Dermatology

Phoenix, Arizona 85008

United States

Phoenix Children'S Hospital

Phoenix, Arizona 85016

United States

Omni Dermatology

Phoenix, Arizona 85037

United States

Affiliated Dermatology

Scottsdale, Arizona 85255

United States

Banner - University Medicine Multispecialty Services Clinic

Tucson, Arizona 85718

United States

Premier Dermatology Clinical Trials Institute At Northwest Arkansas

Fayetteville, Arkansas 72703

United States

Burke Pharmaceutical Research

Hot Springs, Arkansas 71913

United States

Axon Clinical Research

Inglewood, California 90301

United States

University of California Irvine

Irvine, California 92697

United States

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California 90036-5609

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

Rady Children'S Hospital-San Diego

San Diego, California 92123

United States

Golden State Dermatology

Walnut Creek, California 94598

United States

Children'S Hospital Colorado

Aurora, Colorado 80045

United States

Paradigm Clinical Research Centers, Inc.

Wheat Ridge, Colorado 80033

United States

Skin Care Research, Llc

Boca Raton, Florida 33486

United States

Encore Medical Research, Llc Boynton Beach

Boynton Beach, Florida 33436

United States

Skin Care Research, Llc

Hollywood, Florida 33201

United States

Solutions Through Advanced Research, Inc

Jacksonville, Florida 32256

United States

Pediatric Skin Research Llc

Miami, Florida 33146

United States

Nicklaus Children'S Hospital

Miami, Florida 33155

United States

Dh Tamarac Research Center Etna Medical Center Emc

Tamarac, Florida 33321

United States

Usf Health Morsani Center For Advanced Healthcare

Tampa, Florida 33612

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

Forefront Dermatology

Libertyville, Illinois 60048

United States

Northshore University Healthsystem

Skokie, Illinois 60077

United States

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States

Skin and Hair Center

Overland Park, Kansas 66213

United States

Wellskin Dermatology & Aesthetics

Bowling Green, Kentucky 42104

United States

Tulane University Health Sciences Center

New Orleans, Louisiana 70112

United States

Dermatology Associates Pc

Rockville, Maryland 20850

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Metro Boston Clinical Partners

Brighton, Massachusetts 02135-3511

United States

Dermatology and Cosmetic Center

Flint, Michigan 48507

United States

Mi Skin Center, Pllc

Northville, Michigan 48167

United States

Michigan Dermatology Institute

Waterford, Michigan 48328

United States

University of Missouri Kansas City

Kansas City, Missouri 64108

United States

Medisearch Clinical Trials

Saint Joseph, Missouri 64506

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Boeson Research

Missoula, Montana 59804

United States

Skin Specialists Pc the Advanced Skin Research Center

Omaha, Nebraska 68144

United States

The University of New Mexico Unm Health Sciences Center Hsc

Albuquerque, New Mexico 87102

United States

Suny Downstate Medical Center

Brooklyn, New York 11203

United States

The Dermatology Specialists Greenwich

New York, New York 10012

United States

Equity Medical, Llc

New York, New York 10023

United States

Mount Sinai Doctors

New York, New York 10028-3135

United States

Sadick Dermatology Sadick Research Group

New York, New York 10075

United States

Skin Search of Rochester

Rochester, New York 14623

United States

Vitality Clinical Research Llc

Woodbury, New York 11797

United States

Red River Research Partners

Fargo, North Dakota 58103

United States

Wright State Physicians Health Center

Beavercreek, Ohio 45324

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Columbia Dermatology

Columbia, South Carolina 29212

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

3A Research Llc West Location

El Paso, Texas 79902

United States

Reveal Research Institute

Frisco, Texas 75033

United States

Acrc Trials

Grapevine, Texas 07605

United States

Us Dermatology Partners Longview

Longview, Texas 75601

United States

Texas Dermatology and Laser Specialists

San Antonio, Texas 78218

United States

Stryde Research

Southlake, Texas 76092

United States

University of Utah Midvalley Dermatology

Murray, Utah 84107

United States

Jordan Valley Dermatology Center

South Jordan, Utah 84095

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

Kirk Barber Research

Calgary, Alberta T2G 1B1

Canada

Dermatology Research Institute

Calgary, Alberta T2J 7E1

Canada

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

Calgary, Alberta T3B 6A8

Canada

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta T5J 3S9

Canada

Alberta Dermasurgery Centre

Edmonton, Alberta T6G 1C3

Canada

Skin Physicians

Edmonton, Alberta T6W 4V4

Canada

Coal Harbour Rejuvenation Dermatology, Inc.

Vancouver, British Columbia V6C 0C3

Canada

Winnipeg Clinic

Winnipeg, Manitoba R3C 1T6

Canada

Maritime Dermatology

Halifax, Nova Scotia B3K5R3

Canada

Dermcare Clinic

Mississauga, Ontario L4W 0C2

Canada

Dar Clinical Research Inc

Ottawa, Ontario K2T 0N7

Canada

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

Toronto, Ontario M5G1X8

Canada

Cosmetic Dermatology on Bloor

Toronto, Ontario M5S 3B4

Canada

Centre de Recherche St-Louis

Montreal, Quebec H1Y 3L1

Canada

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

Montreal, Quebec H3T 1C5

Canada

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

Québec, Quebec G1V 4G2

Canada

Centre de Recherche Saint-Louis

Québec, Quebec G1W 4R4

Canada

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan S7T 0G3

Canada

Skincare Studio Dermatology Centre

St. John's, A1E 1V4

Canada