A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
- Conditions
- NonSegmental Vitiligo
- Interventions
- Drug: Vehicle Cream
- Registration Number
- NCT06548360
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ruxolitinib 1.5 % Cream Ruxolitinib Cream Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. Vehicle Cream Vehicle Cream Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) Week 24 ≥75% improvement in facial Vitiligo Area Scoring Index.
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) Week 52 ≥50% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) Week 52 ≥90% improvement in facial Vitiligo Area Scoring Index.
Percentage change from baseline in F-BSA Week 24 Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) Week 24 and Week 52 ≥90% improvement in total body Vitiligo Area Scoring Index
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations Weeks 6, 24, 30 and 52 Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Week 24 ≥50% improvement in total body Vitiligo Area Scoring Index.
Number of Treatment Emergent Adverse Events (TEAEs) Up to Week 52 and 30 days TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25) Week 24 and Week 52 ≥25% improvement in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) Week 24 and Week 52 ≥75% improvement in total body Vitiligo Area Scoring Index
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) Week 52 ≥75% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) Week 52 ≥50% improvement in total body Vitiligo Area Scoring Index.
Related Research Topics
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Trial Locations
- Locations (91)
University of Alabama At Birmingham-School of Medicine
🇺🇸Birmingham, Alabama, United States
Phoenix Children'S Hospital
🇺🇸Phoenix, Arizona, United States
Affiliated Dermatology
🇺🇸Scottsdale, Arizona, United States
Banner - University Medicine Multispecialty Services Clinic
🇺🇸Tucson, Arizona, United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
🇺🇸Fayetteville, Arkansas, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Axon Clinical Research
🇺🇸Inglewood, California, United States
University of California Irvine
🇺🇸Irvine, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
La Universal Research Center, Inc
🇺🇸Los Angeles, California, United States
Stanford School of Medicine
🇺🇸Palo Alto, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Norcal Clinical Research
🇺🇸Rocklin, California, United States
Peninsula Research Associates Pra
🇺🇸Rolling Hills Estates, California, United States
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States
Rady Children'S Hospital-San Diego
🇺🇸San Diego, California, United States
Children'S Hospital Colorado
🇺🇸Aurora, Colorado, United States
Paradigm Clinical Research Centers, Inc.
🇺🇸Wheat Ridge, Colorado, United States
Skin Care Research, Llc
🇺🇸Boca Raton, Florida, United States
Encore Medical Research, Llc Boynton Beach
🇺🇸Boynton Beach, Florida, United States
Pediatric Skin Research Llc
🇺🇸Coral Gables, Florida, United States
Skin Care Research, Llc Scr Hollywood
🇺🇸Hollywood, Florida, United States
Solutions Through Advanced Research, Inc
🇺🇸Jacksonville, Florida, United States
Nicklaus Children'S Hospital
🇺🇸Miami, Florida, United States
Dh Tamarac Research Center Etna Medical Center Emc
🇺🇸Tamarac, Florida, United States
Usf Health Morsani Center For Advanced Healthcare
🇺🇸Tampa, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Cleaver Medical Group
🇺🇸Cumming, Georgia, United States
Advanced Medical Research Pc
🇺🇸Sandy Springs, Georgia, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Illinois Dermatology Institute the Chicago Loop
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Advanced Dermatology Lincolnshire
🇺🇸Lincolnshire, Illinois, United States
Northshore University Healthsystem
🇺🇸Skokie, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Wellskin Dermatology & Aesthetics
🇺🇸Bowling Green, Kentucky, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Dermatology Associates Pc
🇺🇸Rockville, Maryland, United States
Massachusetts General Hospital-Dermatology Associates
🇺🇸Boston, Massachusetts, United States
Metro Boston Clinical Partners
🇺🇸Brighton, Massachusetts, United States
Michigan Center For Research Company
🇺🇸Clarkston, Michigan, United States
Medisearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Boeson Research
🇺🇸Missoula, Montana, United States
Skin Specialists Pc the Advanced Skin Research Center
🇺🇸Omaha, Nebraska, United States
The University of New Mexico Unm Health Sciences Center Hsc
🇺🇸Albuquerque, New Mexico, United States
Suny Downstate Medical Center
🇺🇸Brooklyn, New York, United States
The Dermatology Specialists Greenwich
🇺🇸New York, New York, United States
Equity Medical, Llc
🇺🇸New York, New York, United States
Mount Sinai Doctors
🇺🇸New York, New York, United States
Sadick Dermatology Sadick Research Group
🇺🇸New York, New York, United States
Skin Search of Rochester
🇺🇸Rochester, New York, United States
Dermatologists of Southwestern Ohio, Llc
🇺🇸Bexley, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Columbia Dermatology
🇺🇸Columbia, South Carolina, United States
International Clinical Research Tennessee Llc
🇺🇸Murfreesboro, Tennessee, United States
Dell Children'S Medical Group
🇺🇸Austin, Texas, United States
The University of Texas Health Science Center At Houston
🇺🇸Bellaire, Texas, United States
Dfw Clinical Trials
🇺🇸Carrollton, Texas, United States
3A Research Llc West Location
🇺🇸El Paso, Texas, United States
Reveal Research Institute
🇺🇸Frisco, Texas, United States
Pediatric Dermatology of North Texas
🇺🇸Grapevine, Texas, United States
Us Dermatology Partners Longview
🇺🇸Longview, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
University of Utah Midvalley Dermatology
🇺🇸Murray, Utah, United States
Jordan Valley Dermatology Center
🇺🇸South Jordan, Utah, United States
Virginia Clinical Research, Inc Vcr Pariser Dermatology Specialists, Ltd Norfolk Location
🇺🇸Norfolk, Virginia, United States
Frontier Dermatology
🇺🇸Mill Creek, Washington, United States
Seattle Children'S Hospital
🇺🇸Seattle, Washington, United States
Dermatology Specialists of Spokane
🇺🇸Spokane, Washington, United States
University of Wisconsin School of Medicine
🇺🇸Madison, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Kirk Barber Research
🇨🇦Calgary, Alberta, Canada
Dermatology Research Institute
🇨🇦Calgary, Alberta, Canada
Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)
🇨🇦Calgary, Alberta, Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc
🇨🇦Edmonton, Alberta, Canada
Alberta Dermasurgery Centre
🇨🇦Edmonton, Alberta, Canada
Coal Harbour Rejuvenation Dermatology, Inc.
🇨🇦Vancouver, British Columbia, Canada
Winnipeg Clinic
🇨🇦Winnipeg, Manitoba, Canada
Maritime Dermatology
🇨🇦Halifax, Nova Scotia, Canada
Childrens Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Dar Clinical Research Inc
🇨🇦Ottawa, Ontario, Canada
Research Toronto
🇨🇦Toronto, Ontario, Canada
University of Toronto - the Hospital For Sick Children (Sickkids)
🇨🇦Toronto, Ontario, Canada
Dermatelier on Avenue
🇨🇦Toronto, Ontario, Canada
Centre de Recherche St-Louis
🇨🇦Montreal, Quebec, Canada
Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)
🇨🇦Quebec City, Quebec, Canada
Centre de Recherche Saint-Louis
🇨🇦Quebec City, Quebec, Canada
Saskatoon Dermatology Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Skincare Studio Dermatology Centre
🇨🇦St. John's, Canada