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Purpose

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

Condition

Eligibility

Eligible Ages
Between 2 Years and 11 Years
Eligible Genders
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

Affiliated Dermatology
Scottsdale, Arizona 85255

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

Burke Pharmaceutical Research
Hot Springs, Arkansas 71913

Dermatology Associates
Encinitas, California 92024

Dermatology Research Associates
Los Angeles, California 90045

La Universal Research Center, Inc
Los Angeles, California 90057

Empire Clinical Research
Pomona, California 91767

Peninsula Research Associates Pra
Rolling Hills Estates, California 90274-7604

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

Skin Care Research, Llc
Boca Raton, Florida 33486

Pediatric Skin Research Llc
Coral Gables, Florida 33146

Solutions Through Advanced Research, Inc
Jacksonville, Florida 32256

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

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

Northshore University Healthsystem
Skokie, Illinois 60077

Wellskin Dermatology & Aesthetics
Bowling Green, Kentucky 42104

Metro Boston Clinical Partners
Brighton, Massachusetts 02135-3511

Medisearch Clinical Trials
Saint Joseph, Missouri 64506

Boeson Research
Missoula, Montana 59804

Suny Downstate Medical Center
Brooklyn, New York 11203

Equity Medical, Llc
New York, New York 10023

Mount Sinai Doctors
New York, New York 10028-3135

Sadick Dermatology Sadick Research Group
New York, New York 10075

Medical University of South Carolina
Charleston, South Carolina 29425

International Clinical Research Tennessee Llc
Murfreesboro, Tennessee 37130

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

Pediatric Dermatology of North Texas
Grapevine, Texas 76051

Us Dermatology Partners Longview
Longview, Texas 75601

Texas Dermatology and Laser Specialists
San Antonio, Texas 78218

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

More Details

NCT ID
NCT06548360
Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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