Clinical trial NCT06548360: A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Official title: A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: NonSegmental Vitiligo
Keywords: NonSegmental Vitiligo
pediatric
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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.

Primary outcomes:
measure: Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
timeFrame: Week 24
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
timeFrame: Week 24
measure: Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
timeFrame: Week 24
measure: Percentage change from baseline in F-BSA
timeFrame: Week 24
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 52 and 30 days
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
timeFrame: Week 52
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
timeFrame: Week 52
measure: Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
timeFrame: Week 52
measure: Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
timeFrame: Week 52
measure: Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)
timeFrame: Week 24 and Week 52
measure: Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
timeFrame: Week 24 and Week 52
measure: Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)
timeFrame: Week 24 and Week 52
measure: Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
timeFrame: Weeks 6, 24, 30 and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham-School of Medicine
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children'S Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Affiliated Dermatology
state: Arizona
city: Tucson
country: United States
facility: Banner - University Medicine Multispecialty Services Clinic
state: Arizona
city: Fayetteville
country: United States
facility: Premier Dermatology Clinical Trials Institute At Northwest Arkansas
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Encinitas
country: United States
facility: Dermatology Associates
state: California
city: Inglewood
country: United States
facility: Axon Clinical Research
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: La Universal Research Center, Inc
state: California
city: Palo Alto
country: United States
facility: Stanford School of Medicine
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Rocklin
country: United States
facility: Norcal Clinical Research
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates Pra
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: Rady Children'S Hospital-San Diego
state: California
city: Aurora
country: United States
facility: Children'S Hospital Colorado
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research, Llc
state: Florida
city: Boynton Beach
country: United States
facility: Encore Medical Research, Llc Boynton Beach
state: Florida
city: Coral Gables
country: United States
facility: Pediatric Skin Research Llc
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, Llc
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc
state: Florida
city: Miami
country: United States
facility: Nicklaus Children'S Hospital
state: Florida
city: Tamarac
country: United States
facility: Dh Tamarac Research Center Etna Medical Center Emc
state: Florida
city: Tampa
country: United States
facility: Usf Health Morsani Center For Advanced Healthcare
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Cumming
country: United States
facility: Cleaver Medical Group
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research Pc
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Illinois Dermatology Institute the Chicago Loop
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lincolnshire
country: United States
facility: Advanced Dermatology Lincolnshire
state: Illinois
city: Skokie
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Bowling Green
country: United States
facility: Wellskin Dermatology & Aesthetics
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Rockville
country: United States
facility: Dermatology Associates Pc
state: Maryland
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Clarkston
country: United States
facility: Michigan Center For Research Company
state: Michigan
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Omaha
country: United States
facility: Skin Specialists Pc the Advanced Skin Research Center
state: Nebraska
city: Albuquerque
country: United States
facility: The University of New Mexico Unm Health Sciences Center Hsc
state: New Mexico
city: Brooklyn
country: United States
facility: Suny Downstate Medical Center
state: New York
city: New York
country: United States
facility: The Dermatology Specialists Greenwich
state: New York
city: New York
country: United States
facility: Equity Medical, Llc
state: New York
city: New York
country: United States
facility: Mount Sinai Doctors
state: New York
city: New York
country: United States
facility: Sadick Dermatology Sadick Research Group
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester
state: New York
city: Bexley
country: United States
facility: Dermatologists of Southwestern Ohio, Llc
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Columbia Dermatology
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Austin
country: United States
facility: Dell Children'S Medical Group
state: Texas
city: Bellaire
country: United States
facility: The University of Texas Health Science Center At Houston
state: Texas
city: Carrollton
country: United States
facility: Dfw Clinical Trials
state: Texas
city: El Paso
country: United States
facility: 3A Research Llc West Location
state: Texas
city: Frisco
country: United States
facility: Reveal Research Institute
state: Texas
city: Grapevine
country: United States
facility: Pediatric Dermatology of North Texas
state: Texas
city: Longview
country: United States
facility: Us Dermatology Partners Longview
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Murray
country: United States
facility: University of Utah Midvalley Dermatology
state: Utah
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc Vcr Pariser Dermatology Specialists, Ltd Norfolk Location
state: Virginia
city: Mill Creek
country: United States
facility: Frontier Dermatology
state: Washington
city: Seattle
country: United States
facility: Seattle Children'S Hospital
state: Washington
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Calgary
country: Canada
facility: Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)
state: Alberta
city: Edmonton
country: Canada
facility: Laser Rejuvenation Clinics Edmonton D.T. Inc
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Dermasurgery Centre
state: Alberta
city: Vancouver
country: Canada
facility: Coal Harbour Rejuvenation Dermatology, Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Halifax
country: Canada
facility: Maritime Dermatology
state: Nova Scotia
city: Ottawa
country: Canada
facility: Childrens Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: Dar Clinical Research Inc
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto - the Hospital For Sick Children (Sickkids)
state: Ontario
city: Toronto
country: Canada
facility: Dermatelier on Avenue
state: Ontario
city: Montreal
country: Canada
facility: Centre de Recherche St-Louis
state: Quebec
city: Montreal
country: Canada
facility: Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche
state: Quebec
city: Quebec City
country: Canada
facility: Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)
state: Quebec
city: Quebec City
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Dermatology Centre
state: Saskatchewan
city: St. John's
country: Canada
facility: Skincare Studio Dermatology Centre
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: