NonSegmental VitiligoPhase 3TRuE-VIP1NCT06548360
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
A Phase 3 study testing Ruxolitinib Cream in people with NonSegmental Vitiligo, run by Incyte Corporation at 98 sites in 2 countries.
Trial summary
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- NonSegmental Vitiligo
- What is being tested?
- Ruxolitinib Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 98 sitesin 2 countries
- Study dates
- 24 Jan 2025to 20 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
98 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
98 sites in 2 countries
United States79 sites, 69 recruiting
- Recruiting
The University of New Mexico Unm Health Sciences Center Hsc
Albuquerque, New Mexico, 87102
- Recruiting
Children'S Hospital Colorado
Aurora, Colorado, 80045
- Recruiting
Dell Children'S Medical Group
Austin, Texas, 78723
- Recruiting
Wright State Physicians Health Center
Beavercreek, Ohio, 45324
- Recruiting
The University of Texas Health Science Center At Houston
Bellaire, Texas, 77401
- Recruiting
University of Alabama At Birmingham-School of Medicine
Birmingham, Alabama, 35233
- Recruiting
Skin Care Research, Llc
Boca Raton, Florida, 33486
- Recruiting
Treasure Valley Medical Research
Boise, Idaho, 83706
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Completed
Wellskin Dermatology & Aesthetics
Bowling Green, Kentucky, 42104
- Recruiting
Encore Medical Research, Llc Boynton Beach
Boynton Beach, Florida, 33436
- Completed
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135-3511
- Recruiting
Suny Downstate Medical Center
Brooklyn, New York, 11203
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Illinois Dermatology Institute the Chicago Loop
Chicago, Illinois, 60602
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Recruiting
Columbia Dermatology
Columbia, South Carolina, 29212
- Recruiting
Cleaver Medical Group
Cumming, Georgia, 30040
- Recruiting
3A Research Llc West Location
El Paso, Texas, 79902
- Recruiting
Red River Research Partners
Fargo, North Dakota, 58103
- Recruiting
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas, 72703
- Recruiting
Dermatology and Cosmetic Center
Flint, Michigan, 48507
- Recruiting
Reveal Research Institute
Frisco, Texas, 75033
- Recruiting
Acrc Trials
Grapevine, Texas, 07605
- Recruiting
Skin Care Research, Llc
Hollywood, Florida, 33201
- Completed
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
- Recruiting
Axon Clinical Research
Inglewood, California, 90301
- Recruiting
University of California Irvine
Irvine, California, 92697
- Recruiting
Solutions Through Advanced Research, Inc
Jacksonville, Florida, 32256
- Not yet recruiting
University of Missouri Kansas City
Kansas City, Missouri, 64108
- Not yet recruiting
Forefront Dermatology
Libertyville, Illinois, 60048
- Completed
Us Dermatology Partners Longview
Longview, Texas, 75601
- Recruiting
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, 90036-5609
- Recruiting
Dermatology Research Associates
Los Angeles, California, 90045
- Recruiting
La Universal Research Center, Inc
Los Angeles, California, 90057
- Recruiting
University of Wisconsin School of Medicine
Madison, Wisconsin, 53715
- Recruiting
Pediatric Skin Research Llc
Miami, Florida, 33146
- Recruiting
Nicklaus Children'S Hospital
Miami, Florida, 33155
- Recruiting
Frontier Dermatology
Mill Creek, Washington, 98012
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Boeson Research
Missoula, Montana, 59804
- Completed
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
- Recruiting
University of Utah Midvalley Dermatology
Murray, Utah, 84107
- Recruiting
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
- Recruiting
The Dermatology Specialists Greenwich
New York, New York, 10012
- Completed
Equity Medical, Llc
New York, New York, 10023
- Recruiting
Mount Sinai Doctors
New York, New York, 10028-3135
- Completed
Sadick Dermatology Sadick Research Group
New York, New York, 10075
- Recruiting
Mi Skin Center, Pllc
Northville, Michigan, 48167
- Recruiting
Skin Specialists Pc the Advanced Skin Research Center
Omaha, Nebraska, 68144
- Recruiting
Skin and Hair Center
Overland Park, Kansas, 66213
- Recruiting
Stanford School of Medicine
Palo Alto, California, 94304
- Recruiting
Saguaro Dermatology
Phoenix, Arizona, 85008
- Recruiting
Phoenix Children'S Hospital
Phoenix, Arizona, 85016
- Recruiting
Omni Dermatology
Phoenix, Arizona, 85037
- Recruiting
Empire Clinical Research
Pomona, California, 91767
- Recruiting
Skin Search of Rochester
Rochester, New York, 14623
- Recruiting
Dermatology Associates Pc
Rockville, Maryland, 20850
- Completed
Peninsula Research Associates Pra
Rolling Hills Estates, California, 90274-7604
- Completed
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
- Recruiting
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
- Recruiting
Rady Children'S Hospital-San Diego
San Diego, California, 92123
- Recruiting
Advanced Medical Research Pc
Sandy Springs, Georgia, 30328
- Completed
Affiliated Dermatology
Scottsdale, Arizona, 85255
- Recruiting
Seattle Children'S Hospital
Seattle, Washington, 98105
- Recruiting
Northshore University Healthsystem
Skokie, Illinois, 60077
- Recruiting
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
- Recruiting
Stryde Research
Southlake, Texas, 76092
- Recruiting
Dermatology Specialists of Spokane
Spokane, Washington, 99202
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Dh Tamarac Research Center Etna Medical Center Emc
Tamarac, Florida, 33321
- Recruiting
Usf Health Morsani Center For Advanced Healthcare
Tampa, Florida, 33612
- Recruiting
Banner - University Medicine Multispecialty Services Clinic
Tucson, Arizona, 85718
- Not yet recruiting
Golden State Dermatology
Walnut Creek, California, 94598
- Recruiting
Michigan Dermatology Institute
Waterford, Michigan, 48328
- Recruiting
Paradigm Clinical Research Centers, Inc.
Wheat Ridge, Colorado, 80033
- Recruiting
Vitality Clinical Research Llc
Woodbury, New York, 11797
Canada19 sites, 19 recruiting
- Recruiting
Kirk Barber Research
Calgary, Alberta, T2G 1B1
- Recruiting
Dermatology Research Institute
Calgary, Alberta, T2J 7E1
- Recruiting
Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)
Calgary, Alberta, T3B 6A8
- Recruiting
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, T5J 3S9
- Recruiting
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3
- Not yet recruiting
Skin Physicians
Edmonton, Alberta, T6W 4V4
- Recruiting
Maritime Dermatology
Halifax, Nova Scotia, B3K5R3
- Not yet recruiting
Dermcare Clinic
Mississauga, Ontario, L4W 0C2
- Recruiting
Centre de Recherche St-Louis
Montreal, Quebec, H1Y 3L1
- Recruiting
Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche
Montreal, Quebec, H3T 1C5
- Recruiting
Dar Clinical Research Inc
Ottawa, Ontario, K2T 0N7
- Recruiting
Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)
Québec, Quebec, G1V 4G2
- Recruiting
Centre de Recherche Saint-Louis
Québec, Quebec, G1W 4R4
- Recruiting
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, S7T 0G3
- Recruiting
Skincare Studio Dermatology Centre
St. John's, A1E 1V4
- Recruiting
University of Toronto - the Hospital For Sick Children (Sickkids)
Toronto, Ontario, M5G1X8
- Recruiting
Cosmetic Dermatology on Bloor
Toronto, Ontario, M5S 3B4
- Recruiting
Coal Harbour Rejuvenation Dermatology, Inc.
Vancouver, British Columbia, V6C 0C3
- Recruiting
Winnipeg Clinic
Winnipeg, Manitoba, R3C 1T6
About this study
Official title: A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
- Conditions
- NonSegmental Vitiligo
- Being tested
- Ruxolitinib Cream, Vehicle Cream
- Keywords
- NonSegmental Vitiligo, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib CreamDrug
Also called INCB018424 Phosphate Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle CreamDrug
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. Receives: Drug: Ruxolitinib Cream |
| Vehicle Cream | Placebo comparator | Participants received vehicle cream, applied topically to the affected area as defined by the protocol. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 24
Secondary outcomes (13)
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
≥50% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 24
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Measured: Week 24
Percentage change from baseline in F-BSA
Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Measured: Week 24
Number of Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to Week 52 and 30 days
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
≥50% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Measured: Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Measured: Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)
≥25% improvement in total body Vitiligo Area Scoring Index.
Measured: Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
≥75% improvement in total body Vitiligo Area Scoring Index
Measured: Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)
≥90% improvement in total body Vitiligo Area Scoring Index
Measured: Week 24 and Week 52
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Measured: Weeks 6, 24, 30 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start24 Jan 2025
- Primary completion5 Jun 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NonSegmental VitiligoStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548360
- Sponsor's protocol ID
- INCB18424-312
- Acronym
- TRuE-VIP1
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency