Clinical trial NCT04057573: Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
Official title: Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-segmental Vitiligo
Keywords: Vitiligo
non-segmental
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 344
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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).


Eligibility criteria: Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24
timeFrame: Baseline; Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24
timeFrame: Baseline; Week 24
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
timeFrame: from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period
timeFrame: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
measure: Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52
timeFrame: Baseline; Week 52
measure: Percentage Change From Baseline in F-VASI at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in F-VASI at Week 52
timeFrame: Baseline; Week 52
measure: Percentage Change From Baseline in F-BSA at Week 52
timeFrame: Baseline; Week 52
measure: Percentage Change From Baseline in T-VASI at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in T-VASI at Week 52
timeFrame: Baseline; Week 52
measure: Percentage Change From Baseline in T-BSA at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in T-BSA at Week 52
timeFrame: Baseline; Week 52
measure: Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Achieving a ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52
timeFrame: Baseline; Week 52
measure: Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods)
timeFrame: Baseline; Week 24 and Week 52
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in DLQI at Week 52
timeFrame: Baseline; Week 52
measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) During the Treatment Period (Double-Blind and Treatment-Extension Periods)
timeFrame: Baseline; Week 24 and Week 52
measure: Trough Plasma Concentrations of Ruxolitinib at Weeks 4, 24, and 40
timeFrame: pre-dose at Weeks 4, 24, and 40
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Desert Sky Dermatology
state: Arizona
city: Fremont
country: United States
facility: Center For Dermatology Cosmetic and Laser Surgery
state: California
city: Irvine
country: United States
facility: Uci Beckman Laser Institute and Medical Clinic
state: California
city: Irvine
country: United States
facility: UCI Health Beckman Laser Institute and Medical Center
state: California
city: Los Angeles
country: United States
facility: Vitiligo & Pigmentation Institute of Southern California
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Murrieta
country: United States
facility: Dermatology Specialists Inc
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists Inc
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: Acrc Studies
state: California
city: San Diego
country: United States
facility: Central Sooner Research
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center Inc
state: Colorado
city: Miami
country: United States
facility: Advanced Pharma Cr
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Gurnee
country: United States
facility: Ashira Dermatology Llc
state: Illinois
city: West Lafayette
country: United States
facility: Randall Dermatology of West Lafayette
state: Indiana
city: West Lafayette
country: United States
facility: Randall Dermatology
state: Indiana
city: Baton Rouge
country: United States
facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Las Vegas
country: United States
facility: Jdr Dermatology Research
state: Nevada
city: New Hyde Park
country: United States
facility: Northwell Physician Partners
state: New York
city: New York
country: United States
facility: Icahn School of Medicine At Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York Inc
state: New York
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Richmond
country: United States
facility: Clinical Research Partners Llc
state: Virginia
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed Eood
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Ii Sofia Eood
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Aleksandrovska
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center II Sofia EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center II Sofia EOOD
city: Stara Zagora
country: Bulgaria
facility: University Hospital Prof Dr Stoyan Kirkovich
city: Stara Zagora
country: Bulgaria
facility: University Hospital " Prof. Dr Stoyan Kirkovich"
city: Barrie
country: Canada
facility: Simcoderm Medical and Surgical Dermatology Center
state: Ontario
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: Xlr8 Medical Research
state: Ontario
city: Besancon
country: France
facility: Centre Hospitalier Universitaire de Besancon
city: Besancon
country: France
facility: CHU Besancon
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hospital Saint Andre
city: Creteil
country: France
facility: University Hospital Henri Mondor
city: Creteil
country: France
facility: CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR
city: Martigues
country: France
facility: Le Bateau Blanc
city: Berlin
country: Germany
facility: Emovis GMBH
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn Aoer
city: Mahlow
country: Germany
facility: Hautarztpraxis Mahlow
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Mainz
country: Germany
facility: University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz)
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Rome
country: Italy
facility: Istituto Dermatologico San Gallicano
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centre
city: Czestochowa
country: Poland
facility: Synexus Polska Sp. Z o.o. Oddział w Częstochowie
city: Krakow
country: Poland
facility: Synexus Affiliate - Krakowskie Centrum Medyczne
city: Lodz
country: Poland
facility: Synexus Polska Sp Z Oo Oddzial W Lodzi
city: Lublin
country: Poland
facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie
city: Swidnik
country: Poland
facility: Lubeskie Centrum Diagnostyczne
city: Warsaw
country: Poland
facility: High-Med Przychodnia Specjalistycza
city: Warszawa
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial Warszawie
city: Wroclaw
country: Poland
facility: Dermmedica Sp. Z O.O.
city: Badalona
country: Spain
facility: Ico Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Madrid
country: Spain
facility: Dermomedic
city: Madrid
country: Spain
facility: IDEI (Instituto de Dermatología Integral).
city: Madrid
country: Spain
facility: Hospital La Paz (Hospital Universitario La Paz )
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References:
citation: 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.