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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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.
Show all 14Show fewer
  • 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.

Incyte Corporation Call Center (US) contact

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US) contact

+800 00027423

eumedinfo@incyte.com

98 sites in 2 countries

United States79 sites, 69 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

    Recruiting

  • Wellskin Dermatology & Aesthetics

    Bowling Green, Kentucky, 42104

    Completed

  • Encore Medical Research, Llc Boynton Beach

    Boynton Beach, Florida, 33436

    Recruiting

  • Metro Boston Clinical Partners

    Brighton, Massachusetts, 02135-3511

    Completed

  • 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

    Recruiting

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913

    Completed

  • 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

    Recruiting

  • University of Missouri Kansas City

    Kansas City, Missouri, 64108

    Not yet recruiting

  • Forefront Dermatology

    Libertyville, Illinois, 60048

    Not yet recruiting

  • Us Dermatology Partners Longview

    Longview, Texas, 75601

    Completed

  • 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

    Recruiting

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee, 37130

    Completed

  • 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

    Recruiting

  • Equity Medical, Llc

    New York, New York, 10023

    Completed

  • Mount Sinai Doctors

    New York, New York, 10028-3135

    Recruiting

  • Sadick Dermatology Sadick Research Group

    New York, New York, 10075

    Completed

  • 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

    Recruiting

  • Peninsula Research Associates Pra

    Rolling Hills Estates, California, 90274-7604

    Completed

  • Medisearch Clinical Trials

    Saint Joseph, Missouri, 64506

    Completed

  • 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

    Recruiting

  • Affiliated Dermatology

    Scottsdale, Arizona, 85255

    Completed

  • 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

    Recruiting

  • Golden State Dermatology

    Walnut Creek, California, 94598

    Not yet 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

    Recruiting

Other trials in United States

Canada19 sites, 19 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

    Recruiting

  • Skin Physicians

    Edmonton, Alberta, T6W 4V4

    Not yet recruiting

  • Maritime Dermatology

    Halifax, Nova Scotia, B3K5R3

    Recruiting

  • Dermcare Clinic

    Mississauga, Ontario, L4W 0C2

    Not yet 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

    Recruiting

Other trials in Canada

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.

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 groups in NCT06548360
Study groupRoleWhat they receive
Ruxolitinib 1.5 % CreamExperimentalParticipants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Receives: Drug: Ruxolitinib Cream
Vehicle CreamPlacebo comparatorParticipants 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.

  1. 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)

  1. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

    ≥50% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 24

  2. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)

    ≥90% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 24

  3. 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

  4. 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

  5. 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

  6. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

    ≥50% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 52

  7. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)

    ≥75% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 52

  8. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)

    ≥90% improvement in facial Vitiligo Area Scoring Index.

    Measured: Week 52

  9. Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)

    ≥50% improvement in total body Vitiligo Area Scoring Index.

    Measured: Week 52

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted12 Aug 2024
  2. Study start24 Jan 2025
  3. Primary completion5 Jun 2028 (estimated)
  4. Study completion20 Dec 2028 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ruxolitinib Cream in people with NonSegmental Vitiligo, run by Incyte Corporation at 98 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06548360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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