Overview
The purpose of this study is to evaluate the efficacy, safety, and tolerability of MK-6194 in participants with non-segmental vitiligo. The primary hypothesis is that at least 1 MK-6194 dose is superior to placebo with regards to percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24.
Eligibility
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