Before a drug is used to treat a disease, it must be scientifically tested on study participants. Therefore, in this study MK-6194 is tested in adults with non-segmental vitiligo. Vitiligo is a disease in which there is a loss of skin pigment in certain areas of the body. All areas of the body can be affected. MK-6194 is experimental. It is not yet approved.
Aim of the study
The aim is to investigate the safety of MK-6194 and to determine how well it works compared to a placebo.
Who can take part?
You can take part in the study if you are at least 18 years old and have non-segmental vitiligo that has been present for at least 6 months. You must have a loss of pigment (skin color) in areas of your face and other parts of your body.
Procedure
You will be in the study for just over 1 year (14 months) and will visit the study center about 16 times.
The study consists of 3 phases:
1. screening: First, the study staff will check whether you can take part in the study. This is known as the screening phase and lasts up to 1 month. During this time, you will visit the study center one or more times.
2. treatment: If you are able to participate in the study, the next step is the treatment phase. You will be in the treatment phase for just over 1 year (13 months).
3. follow-up: If you no longer receive the study medication, you will enter the follow-up phase. During this phase, you will receive a phone call from the study center approximately 1 month after your last dose of study drug.
Compensation
Original study name
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
BASEC number
2023-01810
Sponsors