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

Purpose

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

Condition

  • NonSegmental Vitiligo

Eligibility

Eligible Ages
Between 2 Years and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama At Birmingham-School of Medicine
Birmingham, Alabama 35233

Saguaro Dermatology
Phoenix, Arizona 85008

Phoenix Children'S Hospital
Phoenix, Arizona 85016

Omni Dermatology
Phoenix, Arizona 85037

Banner - University Medicine Multispecialty Services Clinic
Tucson, Arizona 85718

Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas 72703

Axon Clinical Research
Inglewood, California 90301

University of California Irvine
Irvine, California 92697

Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California 90036-5609

Dermatology Research Associates
Los Angeles, California 90045

La Universal Research Center, Inc
Los Angeles, California 90057

Stanford School of Medicine
Palo Alto, California 94304

Empire Clinical Research
Pomona, California 91767

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

Children'S Hospital Colorado
Aurora, Colorado 80045

Paradigm Clinical Research Centers, Inc.
Wheat Ridge, Colorado 80033

Skin Care Research, Llc
Boca Raton, Florida 33486

Encore Medical Research, Llc Boynton Beach
Boynton Beach, Florida 33436

Skin Care Research, Llc
Hollywood, Florida 33201

Solutions Through Advanced Research, Inc
Jacksonville, Florida 32256

Pediatric Skin Research Llc
Miami, Florida 33146

Nicklaus Children'S Hospital
Miami, Florida 33155

Dh Tamarac Research Center Etna Medical Center Emc
Tamarac, Florida 33321

Usf Health Morsani Center For Advanced Healthcare
Tampa, Florida 33612

Cleaver Medical Group
Cumming, Georgia 30040

Advanced Medical Research Pc
Sandy Springs, Georgia 30328

Treasure Valley Medical Research
Boise, Idaho 83706

Illinois Dermatology Institute the Chicago Loop
Chicago, Illinois 60602

Northwestern Memorial Hospital
Chicago, Illinois 60611

Rush University Medical Center
Chicago, Illinois 60612

Northshore University Healthsystem
Skokie, Illinois 60077

Indiana University School of Medicine
Indianapolis, Indiana 46202

Skin and Hair Center
Overland Park, Kansas 66213

Tulane University Health Sciences Center
New Orleans, Louisiana 70112

Dermatology Associates Pc
Rockville, Maryland 20850

Massachusetts General Hospital
Boston, Massachusetts 02114

Dermatology and Cosmetic Center
Flint, Michigan 48507

Mi Skin Center, Pllc
Northville, Michigan 48167

Michigan Dermatology Institute
Waterford, Michigan 48328

Washington University School of Medicine
St Louis, Missouri 63110

Boeson Research
Missoula, Montana 59804

Skin Specialists Pc the Advanced Skin Research Center
Omaha, Nebraska 68144

The University of New Mexico Unm Health Sciences Center Hsc
Albuquerque, New Mexico 87102

Suny Downstate Medical Center
Brooklyn, New York 11203

The Dermatology Specialists Greenwich
New York, New York 10012

Mount Sinai Doctors
New York, New York 10028-3135

Skin Search of Rochester
Rochester, New York 14623

Red River Research Partners
Fargo, North Dakota 58103

Wright State Physicians Health Center
Beavercreek, Ohio 45324

Medical University of South Carolina
Charleston, South Carolina 29425

Columbia Dermatology
Columbia, South Carolina 29212

Dell Children'S Medical Group
Austin, Texas 78723

The University of Texas Health Science Center At Houston
Bellaire, Texas 77401

3A Research Llc West Location
El Paso, Texas 79902

Reveal Research Institute
Frisco, Texas 75033

Acrc Trials
Grapevine, Texas 07605

Texas Dermatology and Laser Specialists
San Antonio, Texas 78218

Stryde Research
Southlake, Texas 76092

University of Utah Midvalley Dermatology
Murray, Utah 84107

Jordan Valley Dermatology Center
South Jordan, Utah 84095

Frontier Dermatology
Mill Creek, Washington 98012

Seattle Children'S Hospital
Seattle, Washington 98105

Dermatology Specialists of Spokane
Spokane, Washington 99202

University of Wisconsin School of Medicine
Madison, Wisconsin 53715

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com