Non-segmental Vitiligo
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMK-6194
MK-6194 administered subcutaneously (SC)
DRUGPlacebo
Placebo comparator to MK-6194 administered SC
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has a clinical diagnosis of non-segmental vitiligo * Has non-segmental vitiligo with disease duration of at least 6 months * Has depigmentation contributing to Facial Vitiligo Area Scoring Index (F-VASI) ≥ 0.3 at screening and baseline * Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline * Has Total Vitiligo Area Scoring Index (T-VASI) ≥4 at screening and baseline * Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement
Exclusion criteria
* Has segmental vitiligo * Has ≥50% leukotrichia on face or body * Has any other dermatological diseases that would interfere with vitiligo assessments * Has history of or current inflammatory condition other than vitiligo that, in the opinion of the investigator, could interfere with the evaluation of vitiligo * Has a known systemic hypersensitivity to interleukin 2 (IL-2), or modified IL-2 including MK-6194, or its inactive ingredients * Has an active or clinically significant infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to Randomization, or oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization * Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening * Has a severe chronic pulmonary disease requiring oxygen therapy * Has a transplanted organ, which requires continued immunosuppression * Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix * Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB * Has confirmed or suspected COVID-19 infection * Has history of drug or alcohol abuse within 6 months prior to Screening * Has had major surgery within 3 months prior to Screening OR has a major surgery planned during the study * Has had an inadequate response (as evaluated by a dermatologist or local physician specialist equivalent) to previous treatment with a Janus kinase inhibitor (JAKi) after an appropriate treatment duration (eg, ≥12 weeks) * Has received prohibited medications within protocol-specified timeframes prior to Randomization * Has participated in another investigational clinical study within 4 weeks prior to Randomization * Has donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit * Has received cosmetic or other procedures that could interfere with evaluation of vitiligo during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 | Baseline and 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. |
| Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 28 weeks | 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. |
| Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 | Baseline and Week 24 | 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. |
Countries
Argentina, Australia, Belgium, Canada, Chile, Colombia, France, Germany, Israel, Japan, Mexico, Netherlands, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Pre-assignment details
During the Double-Blind Treatment Period, participants received MK-6194 (3 mg every two weeks \[Q2W\] or every four weeks \[Q4W\]) or placebo, administered subcutaneously (SC). Those completing this period entered the Blinded Extension Period. Participants who received MK-6194 continued their regimen and participants who received placebo were re-randomized to MK-6194 3 mg Q2W or Q4W.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.3 Years STANDARD_DEVIATION 12.1 |
| Age, Customized Adults (between 18 and 64 years) | 153 Participants |
| Age, Customized From 65 to 84 years | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Previous JAK Inhibitor Exposure (Yes vs. No) No | 133 Participants |
| Previous JAK Inhibitor Exposure (Yes vs. No) Yes | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 14 Participants |
| Race (NIH/OMB) Asian | 23 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 22 Participants |
| Vitiligo Status (Stable vs Active) Active | 82 Participants |
| Vitiligo Status (Stable vs Active) Stable | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 55 | 0 / 57 | 0 / 34 | 0 / 43 | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 48 / 57 | 43 / 55 | 34 / 57 | 19 / 34 | 27 / 43 | 21 / 27 | 21 / 26 |
| serious Total, serious adverse events | 3 / 57 | 3 / 55 | 0 / 57 | 0 / 34 | 0 / 43 | 0 / 27 | 1 / 26 |
Outcome results
None listed