Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

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

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Vehicle; Drug: ruxolitinib

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Sevlievo, Bulgaria, 05400
    • Medical Center Unimed Eood
  • Sofia, Bulgaria, 01606
    • Medical Center Eurohealth
  • Sofia, Bulgaria, 01000
    • Diagnostic Consultative Center Ii Sofia Eood
  • Sofia, Bulgaria, 01431
    • University Multiprofile Hospital For Active Treatment Aleksandrovska
  • Sofia, Bulgaria, 01592
    • Diagnostic Consultative Center XXVIII - Sofia - EOOD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 0B4
      • Dermatology Research Institute
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Center
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Centre For Dermatology
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
    • Windsor, Ontario, Canada, N8W 1E6
      • Xlr8 Medical Research
  • Quebec
    • Westmount, Quebec, Canada, H3Z 2S6
      • Siena Medical Research Corporation
• France
  • Martigues, France, 13500
    • Le Bateau Blanc
  • Nice, France, 06200
    • Hopital Archet 2 Derm Dept
  • Pessac, France, 33604
    • Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
  • Rouen, France, 76031
    • Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
  • Toulouse, France, 31059
    • Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
• Germany
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus
  • Mahlow, Germany, 15831
    • Hautarztpraxis Mahlow
  • Mainz, Germany, 55131
    • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
  • Muenster, Germany, 48149
    • Universitatsklinik Munster Dermatologie
• Netherlands
  • Amsterdam, Netherlands, 1100 DD
    • Amsterdam University Medical Centre
• Poland
  • Gdansk, Poland, 80-382
    • Synexus - Polska Sp Z Oo Oddzial W Gdansk
  • Gdynia, Poland, 81-537
    • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Katowice, Poland, 40-040
    • Synexus - Sp Z Oo Oddzial W Katowice
  • Krakow, Poland, 31-501
    • Synexus Affiliate - Krakowskie Centrum Medyczne
  • Lodz, Poland, 90-127
    • Synexus Polska Sp Z Oo Oddzial W Lodzi
  • Lublin, Poland, 20-081
    • Synexus Polska Sp Z Oo Oddzial W Czestochowie
  • OSTROWIEC Swietokrzyski, Poland, 27-400
    • Dermedic Dr. Zdybski
  • Poznan, Poland, 60-702
    • Synexus Polska Sp. z o.o. Oddzial w Poznaniu
  • Swidnik, Poland, 21-040
    • Lubeskie Centrum Diagnostyczne
  • Torun, Poland, 87-100
    • Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz
  • Warsaw, Poland, 01-817
    • High-Med Przychodnia Specjalistycza
  • Warsaw, Poland, 01-192
    • Synexus Polska Sp. Z O.O. Oddzial Warszawie
  • Wroclaw, Poland, 50-381
    • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • Wroclaw, Poland, 51-318
    • Dermmedica Sp. Z O.O.
• Spain
  • Badalona, Spain, 08916
    • Ico Hospital Germans Trias I Pujol
  • Madrid, Spain, 28001
    • Dermomedic
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra (CUN)
• United States
  • Alabama
    • Hoover, Alabama, United States, 35244
      • Cahaba Dermatology
  • Arizona
    • Gilbert, Arizona, United States, 85295
      • Desert Sky Dermatology
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Fremont, California, United States, 94538
      • Center For Dermatology Cosmetic and Laser Surgery
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research Llc
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90036
      • Vitiligo & Pigmentation Institute of Southern California
    • San Diego, California, United States, 92119
      • ACRC Studies
    • San Francisco, California, United States, 94158
      • University of California San Francisco
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center Inc
  • Florida
    • Hialeah, Florida, United States, 33016
      • Harmony Medical Research Institute
    • Miami, Florida, United States, 33147
      • Advanced Pharma
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic Inc.
    • Ormond Beach, Florida, United States, 32174
      • Leavitt Medical Associates of Florida
    • Tampa, Florida, United States, 33614
      • Olympian Clinical Research
    • Tampa, Florida, United States, 33613
      • Avita Clinical Research
    • Tampa, Florida, United States, 33624
      • Forcare Clinical Research Fcr Forward Clinical Trials, Inc
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute Inc
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • West Lafayette, Indiana, United States, 47906
      • Randall Dermatology
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Delricht Clinical Research - Clinedge - Ppds Baton Rouge
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Tufts Medical Center
    • Brighton, Massachusetts, United States, 02135
      • Metro Boston Clinical Partners
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group Inc
    • Detroit, Michigan, United States, 48202
      • Henry Ford Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • JDR Dermatology Research
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10012
      • The Dermatology Specialists Greenwich
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of New York Inc
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates Llc
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Kgl Skin Study Center
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Dermatology Associates of Plymouth Meeting
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Palmetto Clinical Trial Services
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research Tennessee Llc
  • Texas
    • Plano, Texas, United States, 75024
      • Innovative Dermatology
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • San Antonio, Texas, United States, 78229
      • The Dermatology and Laser Center of San Antonio
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners Llc
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A : ruxolitinib cream; Participants who achieve complete or almost complete facial repigmentation (achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to ruxolitinib cream.	Drug: ruxolitinib; ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.; Other Names: INCB018424 Cream
Placebo Comparator: Cohort A : Vehicle; Participants who achieve complete or almost complete facial repigmentation (ie, achieve ≥ F VASI90) at Week 52 in the parent study will be assigned to Cohort A and will be randomized 1:1 to vehicle cream.	Drug: Vehicle; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Experimental: Cohort B : roxolitinib cream; Participants who did not achieve ≥ F-VASI90 at Week 52 of the parent studies will be assigned to Cohort B and will continue ruxolitinib cream.	Drug: ruxolitinib; ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.; Other Names: INCB018424 Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Relapse (Defined as <F-VASI75)	Relapse was defined as a loss of 75% improvement from Baseline in the Face Vitiligo Area Scoring Index score (F-VASI75) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to <75%.	from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Loss of Adequate Response	Loss of adequate response was defined as a loss of 90% improvement from Baseline in the F-VASI score (F-VASI90) response, assessed as percentage improvement in the F-VASI score at Baseline (Day 1 of the parent study) to <90%.	from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)
Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period	An F-VASI50 responder achieved at least 50% 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).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period	An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of 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).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period	An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of 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).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Mean F-VASI Scores During the Extension Treatment Period	F-VASI was measured by the percentage of vitiligo involvement (percentage of 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).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Change From Baseline in F-VASI Scores During the Extension Treatment Period	F-VASI was measured by the percentage of vitiligo involvement (percentage of 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). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period	F-VASI was measured by the percentage of vitiligo involvement (percentage of 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). Percentage change = ([post-BL value minus BL value]/BL value) X 100.	Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
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	A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period	A T-VASI75 responder achieved at least 75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period	A T-VASI90 responder achieved at least 90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Mean T-VASI Scores During the Extension Treatment Period	T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Change From Baseline in T-VASI Scores During the Extension Treatment Period	T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from Baseline=post-Baseline value minus the Baseline value.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period	T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to 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 percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Percentage change = ([post-BL value minus BL value]/BL value) X 100.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period	F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the face as compared to total BSA.	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Change From Baseline in F-BSA During the Extension Treatment Period	F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the face as compared to total BSA.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percent Change From Baseline in F-BSA During the Extension Treatment Period	F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period	T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Data are presented as the percentage of BSA involvement in the total body.	up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Change From Baseline in T-BSA During the Extension Treatment Period	T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented as the percentage of BSA involvement in the total body.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percent Change From Baseline in T-BSA During the Extension Treatment Period	T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline (BL) value minus BL value]/BL value) X 100.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period	The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The Baseline facial photograph was shown to the participants for reference, and a mirror was provided for the participants to assess the vitiligo on their face. The participant was asked to respond to the following query: Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, and (5) no longer noticeable.	Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period	The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age ≥16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Daily activities (Questions 3 and 4); Leisure (Questions 5 and 6); Work and school (Question 7); Personal relations (Questions 8 and 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0. For Question 7, "prevented work or studying"=3. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value.	Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.)
Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period	The CDLQI is the youth/children's version of the DLQI. The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Participants age <16 years answered the questionnaire with: (1) very much; (2) a lot; (3) a little; or (4) not at all. The questionnaire was analyzed under 6 headings: Symptoms and feelings (Questions 1 and 2); Leisure (Questions 4, 5, and 6); School or holidays (Question 7); Personal relationships (Questions 3 and 8); Sleep (Question 9); and Treatment (Question 10). The scoring of each question is as follows: very much = 3; quite a lot = 2; only a little = 1; not at all = 0; question unanswered = 0. The total score ranges from 0 to 30; higher scores indicate higher quality of life. Change from Week 52 was calculated as the post-Week 52 value minus the Week 52 value.	Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	A TEAE was defined as any adverse event (AE) reported for the first time or the worsening of a pre-existing event after the first application of study drug in this study. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment.	up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.)
Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104	The steady-state plasma concentration was assessed. Pharmacokinetic blood samples could have been collected at any time prior to study drug application at the site at the Week 80 visit and at any time at the Week 104 (End of Trial) visit. Results from the two parent studies indicated that steady state was reached at or before Week 4, and that, hence, the use of vehicle or ruxolitinib 1.5% in the first 52 weeks of treatment had no impact on the ruxolitinib plasma concentration at the Week 80 and Week 104 (End of Treatment) visits. Thus, the two Cohort B cohorts were combined into a single arm for data analysis in this study.	Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.)

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Chair: Kathleen Butler, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: INCB018424
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: INCB 18424-308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No