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, ≥ 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 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

Phoenix Children'S Hospital
Phoenix 5308655, Arizona 5551752 85016

Banner - University Medicine Multispecialty Services Clinic
Tucson 5318313, Arizona 5551752 85718

Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville 4110486, Arkansas 4099753 72703

Burke Pharmaceutical Research
Hot Springs 4115412, Arkansas 4099753 71913

Axon Clinical Research
Inglewood 5359488, California 5332921 90301

University of California Irvine
Irvine 5359777, California 5332921 92697

Vitiligo & Pigmentation Institute of Southern California
Los Angeles 5368361, California 5332921 90036-5609

Dermatology Research Associates
Los Angeles 5368361, California 5332921 90045

La Universal Research Center, Inc
Los Angeles 5368361, California 5332921 90057

Stanford School of Medicine
Palo Alto 5380748, California 5332921 94304

Empire Clinical Research
Pomona 5384170, California 5332921 91767

Rady Children'S Hospital-San Diego
San Diego 5391811, California 5332921 92123

Children'S Hospital Colorado
Aurora 5412347, Colorado 5417618 80045

Paradigm Clinical Research Centers, Inc.
Wheat Ridge 5443948, Colorado 5417618 80033

Skin Care Research, Llc
Boca Raton 4148411, Florida 4155751 33486

Encore Medical Research, Llc Boynton Beach
Boynton Beach 4148677, Florida 4155751 33436

Skin Care Research, Llc
Hollywood 4158928, Florida 4155751 33201

Solutions Through Advanced Research, Inc
Jacksonville 4160021, Florida 4155751 32256

Pediatric Skin Research Llc
Miami 4164138, Florida 4155751 33146

Nicklaus Children'S Hospital
Miami 4164138, Florida 4155751 33155

Dh Tamarac Research Center Etna Medical Center Emc
Tamarac 4174738, Florida 4155751 33321

Usf Health Morsani Center For Advanced Healthcare
Tampa 4174757, Florida 4155751 33612

Cleaver Medical Group
Cumming 4190396, Georgia 4197000 30040

Advanced Medical Research Pc
Sandy Springs 4221333, Georgia 4197000 30328

Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706

Illinois Dermatology Institute the Chicago Loop
Chicago 4887398, Illinois 4896861 60602

Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612

Northshore University Healthsystem
Skokie 4911600, Illinois 4896861 60077

Indiana University School of Medicine
Indianapolis 4259418, Indiana 4921868 46202

Wellskin Dermatology & Aesthetics
Bowling Green 4285268, Kentucky 6254925 42104

Tulane University Health Sciences Center
New Orleans 4335045, Louisiana 4331987 70112

Dermatology Associates Pc
Rockville 4367175, Maryland 4361885 20850

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

Metro Boston Clinical Partners
Brighton 4931353, Massachusetts 6254926 02135-3511

Boeson Research
Missoula 5666639, Montana 5667009 59804

Skin Specialists Pc the Advanced Skin Research Center
Omaha 5074472, Nebraska 5073708 68144

The University of New Mexico Unm Health Sciences Center Hsc
Albuquerque 5454711, New Mexico 5481136 87102

Suny Downstate Medical Center
Brooklyn 5110302, New York 5128638 11203

The Dermatology Specialists Greenwich
New York 5128581, New York 5128638 10012

Equity Medical, Llc
New York 5128581, New York 5128638 10023

Mount Sinai Doctors
New York 5128581, New York 5128638 10028-3135

Skin Search of Rochester
Rochester 5134086, New York 5128638 14623

Red River Research Partners
Fargo 5059163, North Dakota 5690763 58103

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

Columbia Dermatology
Columbia 4575352, South Carolina 4597040 29212

International Clinical Research Tennessee Llc
Murfreesboro 4644312, Tennessee 4662168 37130

The University of Texas Health Science Center At Houston
Bellaire 4673353, Texas 4736286 77401

3A Research Llc West Location
El Paso 5520993, Texas 4736286 79902

Reveal Research Institute
Frisco 4692559, Texas 4736286 75033

Acrc Trials
Grapevine 4694568, Texas 4736286 07605

Us Dermatology Partners Longview
Longview 4707814, Texas 4736286 75601

Texas Dermatology and Laser Specialists
San Antonio 4726206, Texas 4736286 78218

University of Utah Midvalley Dermatology
Murray 5778755, Utah 5549030 84107

Jordan Valley Dermatology Center
South Jordan 5781770, Utah 5549030 84095

Frontier Dermatology
Mill Creek 5803457, Washington 5815135 98012

Seattle Children'S Hospital
Seattle 5809844, Washington 5815135 98105

Dermatology Specialists of Spokane
Spokane 5811696, Washington 5815135 99202

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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