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

TerminatedPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Non-segmental Vitiligo

Interventions: MK-6194, Placebo

Countries: United States, Argentina, Australia, Belgium, Canada, Chile, Colombia, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (68)

Birmingham, Alabama, United States
Hot Springs, Arkansas, United States
Los Angeles, California, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Brighton, Massachusetts, United States
Canton, Michigan, United States
Columbus, Ohio, United States
Charleston, South Carolina, United States
Murfreesboro, Tennessee, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Córdoba, Córdoba Province, Argentina
Buenos Aires, Argentina
Phillip, Australian Capital Territory, Australia
Westmead, New South Wales, Australia
Carlton, Victoria, Australia
Melbourne, Victoria, Australia
Ghent, Oost-Vlaanderen, Belgium
Leuven, Vlaams-Brabant, Belgium
Surrey, British Columbia, Canada
Québec, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Osorno, Los Lagos Region, Chile
Valdivia, Los Ríos Region, Chile
+ 38 more on CT.gov