Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

NCT04052425 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: INCB 18424-3062019-000846-37
• Study Type: interventional
• Target: 330
• Locations: 8 countries
• Sites: 57

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Conditions

Non-segmental Vitiligo

Keywords

Vitiligo; non-segmental; JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24

  An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

  Baseline; Week 24

Secondary Outcomes (23)

• Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24

  Baseline; Week 24

• Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24

  Baseline; Week 24

• Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24

  Baseline; Week 24

• Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24

  Baseline; Week 24

• Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24

  Baseline; Week 24

Study Arms (4)

Double-Blind Period: Ruxolitinib cream 1.5% BID

EXPERIMENTAL

Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.

Drug: Ruxolitinib cream

Double-Blind Period: Vehicle cream BID

PLACEBO COMPARATOR

Participants applied matching vehicle cream BID for 24 weeks.

Drug: Vehicle

Treatment-Extension Period: Ruxolitinib cream 1.5% BID

EXPERIMENTAL

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.

Drug: Ruxolitinib cream

Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID

EXPERIMENTAL

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period.

Drug: Ruxolitinib cream; Drug: Vehicle

Interventions

Ruxolitinib cream DRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Also known as: INCB018424 cream

Double-Blind Period: Ruxolitinib cream 1.5% BID; Treatment-Extension Period: Ruxolitinib cream 1.5% BID; Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID

Vehicle DRUG

Vehicle cream is a topical formulation applied as a thin film to affected areas.

Double-Blind Period: Vehicle cream BID; Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
• Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
• Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

You may not qualify if:

• No pigmented hair within any of the vitiligo areas on the face.
• Other forms of vitiligo (eg, segmental) or 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).
• Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
• Use of protocol-defined treatments within the indicated washout period before baseline.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (57)

Cahaba Dermatology

Hoover, Alabama, 35244, United States

Location

Cognitive Clinical Trials Scottsdale Btc Ppds

Scottsdale, Arizona, 85260, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Marvel Clinical Research Llc

Huntington Beach, California, 92647, United States

Location

Rady Children'S Hospital - San Diego

San Diego, California, 92123, United States

Location

University of California San Francisco Sub Location

San Francisco, California, 94158, United States

Location

Clinical Research Center of Ct

Danbury, Connecticut, 06810, United States

Location

Harmony Medical Research Institute

Hialeah, Florida, 33016, United States

Location

San Marcus Research Clinic Inc.

Miami Lakes, Florida, 33014, United States

Location

ForCare Medical Center

Tampa, Florida, 33613, United States

Location

Forcare Clinical Research Fcr Forward Clinical Trials, Inc

Tampa, Florida, 33624, United States

Location

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Clinical Trials Management Llc

Metairie, Louisiana, 70006, United States

Location

Great Lakes Research Group Inc

Bay City, Michigan, 48706, United States

Location

Dermatology Specialists of Brighton

Brighton, Michigan, 48114, United States

Location

Suny Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

The Dermatology Specialists Greenwich

New York, New York, 10012, United States

Location

Wake Research Associates Llc

Raleigh, North Carolina, 27612, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Kgl Skin Study Center

Broomall, Pennsylvania, 19008, United States

Location

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Palmetto Clinical Trial Services

Anderson, South Carolina, 29621, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology

Pleven, 05800, Bulgaria

Location

DCC 28

Sofia, 01592, Bulgaria

Location

Medical Center Eurohealth

Sofia, 01606, Bulgaria

Location

Dermatology Research Institute

Calgary, Alberta, T1Y 0B4, Canada

Location

Institute For Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Skin Centre For Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Windsor Clinical Research Inc

Windsor, Ontario, N8W 5L7, Canada

Location

McGill University Health Centre / Carey/Wang Clinic

Montreal, Quebec, H3Z2S6, Canada

Location

Siena Medical Reserch Corporation

Westmount, Quebec, H3Z 2S6, Canada

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44000, France

Location

Chu de Nice - Hopital L'Archet 1

Nice, 06202, France

Location

Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume

Rouen, 76031, France

Location

Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

Toulouse, 31059, France

Location

University Clinic Carl Gustav Carus, Technical University Dresden

Dresden, 01307, Germany

Location

Universitatsklinik Munster Dermatologie

Münster, 48149, Germany

Location

Presidio Ospedaliero Piero Palagi

Florence, 50125, Italy

Location

Istituto Dermatologico San Gallicano

Rome, 00144, Italy

Location

Synexus - Polska Sp Z Oo Oddzial W Gdansk

Gdansk, 80-382, Poland

Location

Synexus Polska Sp. Z O.O. Oddzial W Gdyni

Gdynia, 81-537, Poland

Location

Synexus - Sp Z Oo Oddzial W Katowice

Katowice, 40-040, Poland

Location

Dermedic Dr. Zdybski

Ostrowiec, 27-400, Poland

Location

Synexus Polska Sp. Z O.O. Oddzial W Poznaniu

Poznan, 60-702, Poland

Location

Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

Torun, 87-100, Poland

Location

Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

Wroclaw, 50-381, Poland

Location

Hospital Cima Sanitas

Barcelona, 08034, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Clinica Universidad de Navarra (Cun)

Pamplona, 31008, Spain

Location

Related Publications (3)

• Rosmarin D, Pandya AG, Passeron T, Forman SB, Zdybski J, Amster M, Feser C, Papp KA, Nuara A, Kornacki D, Wei S, Ren H, Harris JE, Ezzedine K. Long-Term Integrated Safety Summary of Ruxolitinib Cream in Phase 3 Clinical Trials of Patients with Vitiligo. Dermatol Ther (Heidelb). 2025 Dec;15(12):3703-3716. doi: 10.1007/s13555-025-01555-3. Epub 2025 Oct 22.

  PMID: 41125994 DERIVED

• Seneschal J, Wolkerstorfer A, Desai SR, Grimes P, Ezzedine K, Pandya AG, Kornacki D, Wei S, Passeron T, Rosmarin D. Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis From Two Phase 3 Studies. Dermatol Ther (Heidelb). 2025 May;15(5):1227-1238. doi: 10.1007/s13555-025-01381-7. Epub 2025 Mar 29.

  PMID: 40156697 DERIVED

• Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.

  PMID: 36260792 DERIVED

Related Links

• Results Plain Language Summary for Upload to Incyteclinicaltrials.com

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: September 20, 2019
• Primary Completion: March 18, 2021
• Study Completion: October 21, 2021
• Last Updated: August 22, 2025
• Results First Posted: September 21, 2022

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (29); PL (7); BU (3); IT (2); CA (6); DE (2); ES (4); FR (4)