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

Launched by MERCK SHARP & DOHME LLC · Oct 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MK-6194 for people with non-segmental vitiligo, a skin condition that causes patches of skin to lose their color. The main goal of the study is to find out how safe MK-6194 is and how well people tolerate it compared to a placebo, which is a harmless pill that looks like the treatment but has no active medication. Researchers want to see if those taking MK-6194 have a greater improvement in the color of their skin, especially on their face.

To participate, individuals need to be between 18 and 75 years old and have been diagnosed with non-segmental vitiligo for at least six months. They should have a certain level of skin depigmentation on their face and body. However, those with other specific skin conditions or serious health issues will not be eligible. Participants can expect regular check-ins with the research team to monitor their health and the effects of the medication. This study is currently active but not recruiting new participants, meaning they’re still gathering data from those already enrolled.

Gender

ALL

Eligibility criteria

• 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

Trial Officials