Clinical trial NCT04530344: Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Official title: A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitiligo
Keywords: INCB018424
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 458
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled and receiving treatment in INCB 18424-306 (NCT04052425) or INCB 18424-307 (NCT04057573) studies evaluating ruxolitinib cream in participants with vitiligo.
* Currently tolerating ruxolitinib cream in the parent study and no safety concerns per investigators judgment.
* Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.
* Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child.
* Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and written assent from the participant when possible.

Exclusion Criteria:

* Has been permanently discontinued from study treatment in the parent study for any reason.
* Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
* Pregnant or breastfeeding woman.
* Participants who live with anyone participating in any current Incyte-sponsored ruxolitinib cream study.

Primary outcomes:
measure: Time to Relapse (Defined as <F-VASI75)
timeFrame: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)
Secondary outcomes:
measure: Time to Loss of Adequate Response
timeFrame: from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)
measure: Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Mean F-VASI Scores During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Change From Baseline in F-VASI Scores During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period
timeFrame: Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Mean T-VASI Scores During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Change From Baseline in T-VASI Scores During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Change From Baseline in F-BSA During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percent Change From Baseline in F-BSA During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period
timeFrame: up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Change From Baseline in T-BSA During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percent Change From Baseline in T-BSA During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period
timeFrame: Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period
timeFrame: Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.)
measure: Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period
timeFrame: Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.)
measure: Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104
timeFrame: Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.)
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Gilbert
country: United States
facility: Desert Sky Dermatology
state: Arizona
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Fremont
country: United States
facility: Center For Dermatology Cosmetic and Laser Surgery
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research Llc
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: San Diego
country: United States
facility: Acrc Studies
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center Inc
state: Colorado
city: Hialeah
country: United States
facility: Harmony Medical Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic Inc.
state: Florida
city: Miami
country: United States
facility: Advanced Pharma
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: Tampa
country: United States
facility: Forcare Clinical Research Fcr Forward Clinical Trials, Inc
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
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: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group Inc
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: Brooklyn
country: United States
facility: Suny Downstate Medical Center
state: New York
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: The Dermatology Specialists Greenwich
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: Raleigh
country: United States
facility: Wake Research Associates Llc
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Broomall
country: United States
facility: Kgl Skin Study Center
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Anderson
country: United States
facility: Palmetto Clinical Trial Services
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Plano
country: United States
facility: Innovative Dermatology
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: The Dermatology and Laser Center of San Antonio
state: Texas
city: Richmond
country: United States
facility: Clinical Research Partners Llc
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
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 Xxviii - Sofia - Eood
city: Sofia
country: Bulgaria
facility: Medical Center Eurohealth
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
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: Peterborough
country: Canada
facility: Skin Centre For Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: Xlr8 Medical Research
state: Ontario
city: Westmount
country: Canada
facility: Siena Medical Research Corporation
state: Quebec
city: Martigues
country: France
facility: Le Bateau Blanc
city: Nice
country: France
facility: Hopital Archet 2 Derm Dept
city: Pessac
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
city: Rouen
country: France
facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
city: Toulouse
country: France
facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Mahlow
country: Germany
facility: Hautarztpraxis Mahlow
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Muenster
country: Germany
facility: Universitatsklinik Munster Dermatologie
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centre
city: Gdansk
country: Poland
facility: Synexus - Polska Sp Z Oo Oddzial W Gdansk
city: Gdynia
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial W Gdyni
city: Katowice
country: Poland
facility: Synexus - Sp Z Oo Oddzial W Katowice
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: OSTROWIEC Swietokrzyski
country: Poland
facility: Dermedic Dr. Zdybski
city: Poznan
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial W Poznaniu
city: Swidnik
country: Poland
facility: Lubeskie Centrum Diagnostyczne
city: Torun
country: Poland
facility: Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz
city: Warsaw
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial Warszawie
city: Warsaw
country: Poland
facility: High-Med Przychodnia Specjalistycza
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
city: Wroclaw
country: Poland
facility: Dermmedica Sp. Z O.O.
city: Badalona
country: Spain
facility: Ico Hospital Germans Trias I Pujol
city: Madrid
country: Spain
facility: Dermomedic
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra (Cun)
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_CHAIR
References: