Researchers are looking for a new way to treat people with non-segmental vitiligo (NSV). The goal of this study is to learn about the safety of MK-6194 and how well people tolerate it. Researchers also want to learn if people who take MK-6194 have more of a decrease in the amount of vitiligo on their face compared to people who take placebo.
This study will consist of two periods. During the Double-Blind Treatment Period, participants will be randomized to one of three treatment arms to receive MK-6194 at one of two doses or placebo and will be evaluated for safety and efficacy. Participants who complete this period may enter the Blinded Extension Period, during which MK-6194 treatment will continue or placebo recipients will be re-randomized to MK-6194 at one of two doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
169
Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
VASI is a validated scoring method that measures the extent and severity of vitiligo depigmentation. The F-VASI measures vitiligo involvement of the facial area. For facial lesions, size is estimated using fingertip units (FTU), fingers, or thumbs: 1 FTU is approximately 0.03% body surface area (BSA), while a finger or thumb is approximately 0.1% BSA. Depigmentation at each site is graded to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. F-VASI is calculated by multiplying the area (in FTUs) by the depigmentation percentage for each facial site and summing the values. Scores range from 0 to approximately 3.5, with higher scores indicating greater vitiligo involvement of the facial area (more severe depigmentation). Percent change from baseline calculated as post-baseline value minus baseline value, divided by baseline value and multiplied by 100%. Longitudinal data analysis (LDA) model-based least squares mean (LSM) percent change from baseline to Week 24 was reported.
Time frame: Baseline and Week 24
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who experienced an AE is reported.
Time frame: Up to approximately 28 weeks
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here.
Time frame: Up to approximately 24 weeks
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
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Cahaba Dermatology & Skin Health Center ( Site 0127)
Birmingham, Alabama, United States
Burke Pharmaceutical Research ( Site 0124)
Hot Springs, Arkansas, United States
The Vitiligo & Pigmentation Institute of Southern California ( Site 0115)
Los Angeles, California, United States
Indiana University Health University Hospital-Indiana University School of Medicine, Department of (
Indianapolis, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC ( Site 0106)
Indianapolis, Indiana, United States
Metro Boston Clinical Partners ( Site 0110)
Brighton, Massachusetts, United States
Hamzavi Dermatology - Canton ( Site 0101)
Canton, Michigan, United States
Remington Davis Clinical Research-Outpatient ( Site 0104)
Columbus, Ohio, United States
Medical University of South Carolina-Dermatology Research ( Site 0114)
Charleston, South Carolina, United States
International Clinical Research - Tennessee LLC ( Site 0120)
Murfreesboro, Tennessee, United States
...and 58 more locations
T-VASI is a validated scoring method that measures the extent and severity of vitiligo across the entire body. The body is divided into six regions: head/neck, hands, upper extremities, trunk, lower extremities, and feet. One hand unit (palm and fingers together) represents 1% of BSA. Depigmentation for each region is graded to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. For regions with multiple lesions, percentages are averaged. The T-VASI score is calculated by multiplying the area (in hand units) by the depigmentation percentage for each region and summing all regions. Scores range from 0 to 100, with 0 indicating no vitiligo and 100 indicating complete body involvement. Percent change from baseline calculated as post-baseline value minus baseline value, divided by baseline value and multiplied by 100%. LDA model-based LSM percent change from baseline to Week 24 was reported.
Time frame: Baseline and Week 24