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

Primary Purpose

Vitiligo

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ruxolitinib

Vehicle

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring INCB018424

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cahaba Dermatology
Desert Sky Dermatology
First Oc Dermatology
Center For Dermatology Cosmetic and Laser Surgery
Marvel Clinical Research Llc
Vitiligo & Pigmentation Institute of Southern California
Dermatology Research Associates
Acrc Studies
University of California San Francisco
Colorado Medical Research Center Inc
Harmony Medical Research Institute
San Marcus Research Clinic Inc.
Advanced Pharma
Leavitt Medical Associates of Florida
Avita Clinical Research
Olympian Clinical Research
Forcare Clinical Research Fcr Forward Clinical Trials, Inc
Metabolic Research Institute Inc
Northwestern University
Randall Dermatology
Delricht Clinical Research - Clinedge - Ppds Baton Rouge
Tufts Medical Center
Metro Boston Clinical Partners
Great Lakes Research Group Inc
Henry Ford Medical Center
Minnesota Clinical Study Center
Jdr Dermatology Research
Suny Downstate Medical Center
Forest Hills Dermatology Group
The Dermatology Specialists Greenwich
Icahn School of Medicine At Mount Sinai
Derm Research Center of New York Inc
Wake Research Associates Llc
Wake Forest University
Central Sooner Research
Kgl Skin Study Center
Dermatology Associates of Plymouth Meeting
Palmetto Clinical Trial Services
International Clinical Research Tennessee Llc
Innovative Dermatology
Progressive Clinical Research
The Dermatology and Laser Center of San Antonio
Clinical Research Partners Llc
Dermatology Specialists of Spokane
Medical Center Unimed Eood
Diagnostic Consultative Center Ii Sofia Eood
University Multiprofile Hospital For Active Treatment Aleksandrovska
Diagnostic Consultative Center Xxviii - Sofia - Eood
Medical Center Eurohealth
Dermatology Research Institute
Simcoderm Medical and Surgical Dermatology Center
Kingsway Clinical Research
Lynderm Research Inc
Skin Centre For Dermatology
K. Papp Clinical Research
Xlr8 Medical Research
Siena Medical Research Corporation
Le Bateau Blanc
Hopital Archet 2 Derm Dept
Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque
Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume
Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol
Universitaetsklinikum Carl Gustav Carus
Hautarztpraxis Mahlow
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Universitatsklinik Munster Dermatologie
Amsterdam University Medical Centre
Synexus - Polska Sp Z Oo Oddzial W Gdansk
Synexus Polska Sp. Z O.O. Oddzial W Gdyni
Synexus - Sp Z Oo Oddzial W Katowice
Synexus Affiliate - Krakowskie Centrum Medyczne
Synexus Polska Sp Z Oo Oddzial W Lodzi
Synexus Polska Sp Z Oo Oddzial W Czestochowie
Dermedic Dr. Zdybski
Synexus Polska Sp. Z O.O. Oddzial W Poznaniu
Lubeskie Centrum Diagnostyczne
Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz
Synexus Polska Sp. Z O.O. Oddzial Warszawie
High-Med Przychodnia Specjalistycza
Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu
Dermmedica Sp. Z O.O.
Ico Hospital Germans Trias I Pujol
Dermomedic
Clinica Universidad de Navarra (Cun)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Cohort A : ruxolitinib cream

Cohort A : Vehicle

Cohort B : roxolitinib cream

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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%.

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).

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).

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).

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).

Change From Baseline in F-VASI Scores During the Extension Treatment Period

Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period

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).

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).

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).

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).

Change From Baseline in T-VASI Scores During the Extension Treatment Period

Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04530344

First Posted

August 25, 2020

Last Updated

June 28, 2023

Sponsor

Incyte Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04530344

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 24, 2020 (Actual)

Primary Completion Date

November 14, 2022 (Actual)

Study Completion Date

November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitiligo

Keywords

INCB018424

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double Blind

Allocation

Randomized

Enrollment

458 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A : ruxolitinib cream

Arm Type

Experimental

Arm Description

Arm Title

Cohort A : Vehicle

Arm Type

Placebo Comparator

Arm Description

Arm Title

Cohort B : roxolitinib cream

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

ruxolitinib

Other Intervention Name(s)

INCB018424 Cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vehicle

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to Relapse (Defined as <F-VASI75)

Description

Time Frame

from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)

Secondary Outcome Measure Information:

Title

Time to Loss of Adequate Response

Description

Time Frame

from Week 52 (first visit of this Treatment Extension study) to Week 104 (end of treatment in this Treatment Extension study)

Title

Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percentage of Participants Achieving a ≥75% Improvement From Baseline in the F-VASI (F-VASI75) Score During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percentage of Participants Achieving a ≥90% Improvement From Baseline in the F-VASI (F-VASI90) Score During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Mean F-VASI Scores During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Change From Baseline in F-VASI Scores During the Extension Treatment Period

Description

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percent Change From Baseline in F-VASI Scores During the Extension Treatment Period

Description

Time Frame

Baseline (BL); up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

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

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percentage of Participants Achieving a ≥75% Improvement From Baseline in the T-VASI (T-VASI75) Score During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percentage of Participants Achieving a ≥90% Improvement From Baseline in the T-VASI (T-VASI90) Score During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Mean T-VASI Scores During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Change From Baseline in T-VASI Scores During the Extension Treatment Period

Description

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percent Change From Baseline in T-VASI Scores During the Extension Treatment Period

Description

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Mean Facial Body Surface Area (F-BSA) During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Change From Baseline in F-BSA During the Extension Treatment Period

Description

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.

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percent Change From Baseline in F-BSA During the Extension Treatment Period

Description

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.

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Mean Total Body Surface Area (T-BSA) During the Extension Treatment Period

Description

Time Frame

up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Change From Baseline in T-BSA During the Extension Treatment Period

Description

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.

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percent Change From Baseline in T-BSA During the Extension Treatment Period

Description

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.

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5 During the Extension Treatment Period

Description

Time Frame

Baseline; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Change From Week 52 in Dermatology Life Quality Index (DLQI) Total Score During the Extension Treatment Period

Description

Time Frame

Week 52; up to up to Week 104 of Extension Study (Week 52 was the first visit of this Treatment Extension study.)

Title

Change From Week 52 in Children's Dermatology Life Quality Index (CDLQI) Total Score During the Extension Treatment Period

Description

Time Frame

Week 52; up to Week 104 of Treatment Extension (Week 52 was the first visit of this Treatment Extension study.)

Title

Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

Description

Time Frame

up to approximately Week 108 (Week 52 was the first visit of this Treatment Extension study.)

Title

Trough Plasma Concentrations of Ruxolitinib at Week 80 and Week 104

Description

Time Frame

Weeks 80 (predose); Week 104 (any time post-dose) (Week 52 was the first visit of this Treatment Extension study.)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen Butler, MD

Organizational Affiliation

Incyte Corporation

Official's Role

Study Chair

Facility Information:

Facility Name

Cahaba Dermatology

City

Hoover

State/Province

Alabama

ZIP/Postal Code

35244

Country

United States

Facility Name

Desert Sky Dermatology

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85295

Country

United States

Facility Name

First Oc Dermatology

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Center For Dermatology Cosmetic and Laser Surgery

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

Marvel Clinical Research Llc

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

Vitiligo & Pigmentation Institute of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Acrc Studies

City

San Diego

State/Province

California

ZIP/Postal Code

92119

Country

United States

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

Colorado Medical Research Center Inc

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Harmony Medical Research Institute

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

San Marcus Research Clinic Inc.

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Advanced Pharma

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

Leavitt Medical Associates of Florida

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Avita Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Olympian Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Forcare Clinical Research Fcr Forward Clinical Trials, Inc

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Metabolic Research Institute Inc

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Randall Dermatology

City

West Lafayette

State/Province

Indiana

ZIP/Postal Code

47906

Country

United States

Facility Name

Delricht Clinical Research - Clinedge - Ppds Baton Rouge

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02116

Country

United States

Facility Name

Metro Boston Clinical Partners

City

Brighton

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

Great Lakes Research Group Inc

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48706

Country

United States

Facility Name

Henry Ford Medical Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Minnesota Clinical Study Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Jdr Dermatology Research

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Suny Downstate Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

Forest Hills Dermatology Group

City

Kew Gardens

State/Province

New York

ZIP/Postal Code

11415

Country

United States

Facility Name

The Dermatology Specialists Greenwich

City

New York

State/Province

New York

ZIP/Postal Code

10012

Country

United States

Facility Name

Icahn School of Medicine At Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Derm Research Center of New York Inc

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11790

Country

United States

Facility Name

Wake Research Associates Llc

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Central Sooner Research

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Kgl Skin Study Center

City

Broomall

State/Province

Pennsylvania

ZIP/Postal Code

19008

Country

United States

Facility Name

Dermatology Associates of Plymouth Meeting

City

Plymouth Meeting

State/Province

Pennsylvania

ZIP/Postal Code

19462

Country

United States

Facility Name

Palmetto Clinical Trial Services

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

International Clinical Research Tennessee Llc

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37130

Country

United States

Facility Name

Innovative Dermatology

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Progressive Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78213

Country

United States

Facility Name

The Dermatology and Laser Center of San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Clinical Research Partners Llc

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23226

Country

United States

Facility Name

Dermatology Specialists of Spokane

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Medical Center Unimed Eood

City

Sevlievo

ZIP/Postal Code

05400

Country

Bulgaria

Facility Name

Diagnostic Consultative Center Ii Sofia Eood

City

Sofia

ZIP/Postal Code

01000

Country

Bulgaria

Facility Name

University Multiprofile Hospital For Active Treatment Aleksandrovska

City

Sofia

ZIP/Postal Code

01431

Country

Bulgaria

Facility Name

Diagnostic Consultative Center Xxviii - Sofia - Eood

City

Sofia

ZIP/Postal Code

01592

Country

Bulgaria

Facility Name

Medical Center Eurohealth

City

Sofia

ZIP/Postal Code

01606

Country

Bulgaria

Facility Name

Dermatology Research Institute

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T1Y 0B4

Country

Canada

Facility Name

Simcoderm Medical and Surgical Dermatology Center

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

Kingsway Clinical Research

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M8X 1Y9

Country

Canada

Facility Name

Lynderm Research Inc

City

Markham

State/Province

Ontario

ZIP/Postal Code

L3P 1X2

Country

Canada

Facility Name

Skin Centre For Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

K. Papp Clinical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Xlr8 Medical Research

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 1E6

Country

Canada

Facility Name

Siena Medical Research Corporation

City

Westmount

State/Province

Quebec

ZIP/Postal Code

H3Z 2S6

Country

Canada

Facility Name

Le Bateau Blanc

City

Martigues

ZIP/Postal Code

13500

Country

France

Facility Name

Hopital Archet 2 Derm Dept

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Name

Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

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

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Universitaetsklinikum Carl Gustav Carus

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Hautarztpraxis Mahlow

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Universitatsklinik Munster Dermatologie

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Amsterdam University Medical Centre

City

Amsterdam

ZIP/Postal Code

1100 DD

Country

Netherlands

Facility Name

Synexus - Polska Sp Z Oo Oddzial W Gdansk

City

Gdansk

ZIP/Postal Code

80-382

Country

Poland

Facility Name

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

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

Synexus - Sp Z Oo Oddzial W Katowice

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Synexus Affiliate - Krakowskie Centrum Medyczne

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Synexus Polska Sp Z Oo Oddzial W Lodzi

City

Lodz

ZIP/Postal Code

90-127

Country

Poland

Facility Name

Synexus Polska Sp Z Oo Oddzial W Czestochowie

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Dermedic Dr. Zdybski

City

OSTROWIEC Swietokrzyski

ZIP/Postal Code

27-400

Country

Poland

Facility Name

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

City

Poznan

ZIP/Postal Code

60-702

Country

Poland

Facility Name

Lubeskie Centrum Diagnostyczne

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Synexus Polska Sp. Z O.O. Oddzial Warszawie

City

Warsaw

ZIP/Postal Code

01-192

Country

Poland

Facility Name

High-Med Przychodnia Specjalistycza

City

Warsaw

ZIP/Postal Code

01-817

Country

Poland

Facility Name

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

City

Wroclaw

ZIP/Postal Code

50-381

Country

Poland

Facility Name

Dermmedica Sp. Z O.O.

City

Wroclaw

ZIP/Postal Code

51-318

Country

Poland

Facility Name

Ico Hospital Germans Trias I Pujol

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Dermomedic

City

Madrid

ZIP/Postal Code

28001

Country

Spain

Facility Name

Clinica Universidad de Navarra (Cun)

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

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

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