NCT06113328

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Non-Segmental Vitiligo

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-segmental Vitiligo

Interventions

Type	Name	Description
BIOLOGICAL	MK-6194	MK-6194 administered subcutaneously (SC)
DRUG	Placebo	Placebo comparator to MK-6194 administered SC

Timeline

• Start date: 2023-11-27
• Primary completion: 2025-03-20
• Completion: 2025-07-30
• First posted: 2023-11-02
• Last updated: 2026-03-17
• Results posted: 2026-03-17

Locations

68 sites across 18 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Colombia, France, Germany, Israel, Japan, Mexico, Netherlands, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study