Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)

NCT04057573 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: INCB 18424-3072019-000847-28
• Study Type: interventional
• Target: 344
• Locations: 9 countries
• Sites: 76

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 (76)

Desert Sky Dermatology

Gilbert, Arizona, 85295, United States

Location

Center For Dermatology Cosmetic and Laser Surgery

Fremont, California, 94538, United States

Location

Uci Beckman Laser Institute and Medical Clinic

Irvine, California, 92617, United States

Location

UCI Health Beckman Laser Institute and Medical Center

Irvine, California, 92697, United States

Location

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Dermatology Specialists Inc

Murrieta, California, 92562, United States

Location

Dermatology Specialists Inc

Oceanside, California, 92056, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Acrc Studies

San Diego, California, 92119, United States

Location

Central Sooner Research

San Diego, California, 92123, United States

Location

Colorado Medical Research Center Inc

Denver, Colorado, 80210, United States

Location

Advanced Pharma Cr

Miami, Florida, 33147, United States

Location

Leavitt Medical Associates of Florida

Ormond Beach, Florida, 32174, United States

Location

Avita Clinical Research

Tampa, Florida, 33613, United States

Location

Olympian Clinical Research

Tampa, Florida, 33614, United States

Location

Ashira Dermatology Llc

Gurnee, Illinois, 60031, United States

Location

Randall Dermatology of West Lafayette

West Lafayette, Indiana, 47096, United States

Location

Randall Dermatology

West Lafayette, Indiana, 47906, United States

Location

Delricht Clinical Research - Clinedge - Ppds Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02116, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Minnesota Clinical Study Center

Minneapolis, Minnesota, 55432, United States

Location

Jdr Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Northwell Physician Partners

New Hyde Park, New York, 11042, United States

Location

Icahn School of Medicine At Mount Sinai

New York, New York, 10029, United States

Location

Derm Research Center of New York Inc

Stony Brook, New York, 11790, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Clinical Research Partners Llc

Richmond, Virginia, 23220, United States

Location

Medical Center Unimed Eood

Sevlievo, 05400, Bulgaria

Location

Medical Center Unimed EOOD

Sevlievo, 5300, Bulgaria

Location

Diagnostic Consultative Center Ii Sofia Eood

Sofia, 01000, Bulgaria

Location

University Multiprofile Hospital For Active Treatment Aleksandrovska

Sofia, 01431, Bulgaria

Location

Diagnostic Consultative Center II Sofia EOOD

Sofia, 1000, Bulgaria

Location

Diagnostic Consultative Center II Sofia EOOD

Sofia, 1407, Bulgaria

Location

University Hospital Prof Dr Stoyan Kirkovich

Stara Zagora, 06003, Bulgaria

Location

University Hospital " Prof. Dr Stoyan Kirkovich"

Stara Zagora, 6003, Bulgaria

Location

Simcoderm Medical and Surgical Dermatology Center

Barrie, Ontario, L4M 7G1, Canada

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Xlr8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

Centre Hospitalier Universitaire de Besancon

Besançon, 25000, France

Location

CHU Besancon

Besançon, 25030, France

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

CHU de Bordeaux, Hospital Saint Andre

Bordeaux, 33075, France

Location

University Hospital Henri Mondor

Créteil, 94000, France

Location

CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR

Créteil, 94010, France

Location

Le Bateau Blanc

Martigues, 13500, France

Location

Emovis GMBH

Berlin, 10629, Germany

Location

Universitatsklinikum Bonn Aoer

Bonn, 53127, Germany

Location

Hautarztpraxis Mahlow

Mahlow, 15831, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz)

Mainz, 55131, Germany

Location

Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Istituto Dermatologico San Gallicano

Rome, 00163, Italy

Location

Amsterdam University Medical Centre

Amsterdam, 1105 AZ, Netherlands

Location

Synexus Polska Sp. Z o.o. Oddział w Częstochowie

Częstochowa, 42-202, Poland

Location

Synexus Affiliate - Krakowskie Centrum Medyczne

Krakow, 31-501, Poland

Location

Synexus Polska Sp Z Oo Oddzial W Lodzi

Lodz, 90-127, Poland

Location

Synexus Polska Sp Z Oo Oddzial W Czestochowie

Lublin, 20-081, Poland

Location

Lubeskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

Synexus Polska Sp. Z O.O. Oddzial Warszawie

Warsaw, 01-192, Poland

Location

High-Med Przychodnia Specjalistycza

Warsaw, 01-817, Poland

Location

Dermmedica Sp. Z O.O.

Wroclaw, 51-318, Poland

Location

Ico Hospital Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 8916, Spain

Location

Dermomedic

Madrid, 28001, Spain

Location

IDEI (Instituto de Dermatología Integral).

Madrid, 28010, Spain

Location

Hospital La Paz (Hospital Universitario La Paz )

Madrid, 28046, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Related Publications (4)

• 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

• Bibeau K, Butler K, Wang M, Skaltsa K, Hamzavi IH. Psychometric Evaluation of the Facial and Total Vitiligo Area Scoring Index Instruments in the TRuE-V Phase 3 Studies. Dermatol Ther (Heidelb). 2024 Aug;14(8):2223-2234. doi: 10.1007/s13555-024-01223-y. Epub 2024 Jul 30.

  PMID: 39078582 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

• 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

Limitations and Caveats

Data from participants at a single site were excluded from all efficacy analyses done on the Intent-to-Treat Population owing to serious noncompliance with the protocol resulting in serious concerns with the data quality.

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 14, 2019
• First Posted: August 15, 2019
• Study Start: October 3, 2019
• Primary Completion: March 15, 2021
• Study Completion: October 1, 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

DE (5); US (34); ES (6); CA (5); BU (8); FR (7); IT (2); NL (1); PL (8)