A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
NCT ID: NCT06113328
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
169 participants
INTERVENTIONAL
2023-11-27
2025-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Base Study: Dose 1
Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
MK-6194
MK-6194 administered subcutaneously (SC)
Base Study: Dose 2
Participants receive SC MK-6194 dose regimen 2.
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Base Study: Placebo
Participants receive an SC placebo regimen.
Placebo
Placebo comparator to MK-6194 administered SC
Extension: Dose 1
Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
MK-6194
MK-6194 administered subcutaneously (SC)
Extension: Dose 2
Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Interventions
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MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Eligibility Criteria
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Inclusion Criteria
* 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 ≥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
18 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Cahaba Dermatology & Skin Health Center ( Site 0127)
Birmingham, Alabama, United States
Burke Pharmaceutical Research ( Site 0124)
Hot Springs, Arkansas, United States
The Vitiligo & Pigmentation Institute of Southern California ( Site 0115)
Los Angeles, California, United States
Indiana University Health University Hospital-Indiana University School of Medicine, Department of (
Indianapolis, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC ( Site 0106)
Indianapolis, Indiana, United States
Metro Boston Clinical Partners ( Site 0110)
Brighton, Massachusetts, United States
Hamzavi Dermatology - Canton ( Site 0101)
Canton, Michigan, United States
Remington Davis Clinical Research-Outpatient ( Site 0104)
Columbus, Ohio, United States
Medical University of South Carolina-Dermatology Research ( Site 0114)
Charleston, South Carolina, United States
International Clinical Research - Tennessee LLC ( Site 0120)
Murfreesboro, Tennessee, United States
Progressive Clinical Research ( Site 0108)
San Antonio, Texas, United States
Virginia Clinical Research, Inc. ( Site 0109)
Norfolk, Virginia, United States
Dermatology Specialists of Spokane ( Site 0126)
Spokane, Washington, United States
Psoriahue ( Site 0205)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Stat Research S.A. ( Site 0204)
Buenos Aires, Buenos Aires F.D., Argentina
Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Medico Strusberg ( Site 0208)
Córdoba, Córdoba Province, Argentina
Hospital Aleman-Dermatologia ( Site 0209)
Buenos Aires, , Argentina
Paratus Clinical Research Woden ( Site 1703)
Phillip, Australian Capital Territory, Australia
Westmead Hospital-Dermatology ( Site 1701)
Westmead, New South Wales, Australia
Skin Health Institute Inc.-Trials ( Site 1702)
Carlton, Victoria, Australia
Sinclair Dermatology ( Site 1704)
Melbourne, Victoria, Australia
UZ Gent ( Site 0604)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0601)
Leuven, Vlaams-Brabant, Belgium
Enverus Medical Research ( Site 0006)
Surrey, British Columbia, Canada
Diex Recherche Quebec Inc. ( Site 0008)
Québec, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain ( Site 0002)
Québec, Quebec, Canada
Diex Recherche sherbrooke Inc. ( Site 0007)
Sherbrooke, Quebec, Canada
Dermisur ( Site 0305)
Osorno, Los Lagos Region, Chile
Clinical Research Chile SpA ( Site 0304)
Valdivia, Los Ríos Region, Chile
Clinica Dermacross ( Site 0301)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0308)
Santiago, Region M. de Santiago, Chile
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
Santiago, Region M. de Santiago, Chile
CliniSalud ( Site 0401)
Envigado, Antioquia, Colombia
IPS SURA San Diego ( Site 0408)
Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe ( Site 0405)
Barranquilla, Atlántico, Colombia
Healthy Medical Center S.A.S ( Site 0403)
Zipaquirá, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0412)
Cali, Valle del Cauca Department, Colombia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0803)
Nice, Alpes-Maritimes, France
CHU de Bordeaux Hop St ANDRE ( Site 0804)
Bordeaux, Aquitaine, France
Hôpital Edouard Herriot ( Site 0802)
Lyon, Auvergne-Rhône-Alpes, France
HENRI MONDOR HOSPITAL ( Site 0801)
Créteil, Val-de-Marne, France
Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905)
Erlangen, Bavaria, Germany
Universitätsklinikum Münster-Hautklinik ( Site 0904)
Münster, North Rhine-Westphalia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)
Berlin, , Germany
Rambam Health Care Campus-Dermatology ( Site 1002)
Haifa, , Israel
Sheba Medical Center-Dermatology ( Site 1001)
Ramat Gan, , Israel
Nagoya City University Hospital-Dermatology ( Site 2002)
Nagoya, Aichi-ken, Japan
Osaka University Hospital ( Site 2004)
Suita, Osaka, Japan
Tokyo Medical University Hospital ( Site 2001)
Shinjuku-ku, Tokyo, Japan
Cryptex Investigación Clínica S.A. de C.V. ( Site 0515)
Cuauhtémoc, Ciudad de México, Mexico City, Mexico
Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0504)
Monterrey, Nuevo León, Mexico
Centro de Atención e Investigación Clínica ( Site 0507)
Aguascalientes, , Mexico
Amsterdam UMC, locatie AMC-Dermatology ( Site 1101)
Amsterdam, North Holland, Netherlands
Inha University Hospital ( Site 1992)
Incheon, , South Korea
Seoul National University Hospital-Dermatology ( Site 1991)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System-Department of Dermatology ( Site 1993)
Seoul, , South Korea
Hospital Universitario Puerta del Mar ( Site 1302)
Cadiz, Andalusia, Spain
Hospital Universitari de Bellvitge-Dermatology ( Site 1307)
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra ( Site 1305)
Madrid, Madrid, Comunidad de, Spain
Cantonal Hospital St.Gallen ( Site 1402)
Sankt Gallen, Canton of St. Gallen, Switzerland
UniversitätsSpital Zürich ( Site 1401)
Zurich, Canton of Zurich, Switzerland
Hacettepe Universite Hastaneleri-Dermatology ( Site 1501)
Altindağ, Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)
Ankara, , Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri-Dermatology and Venereology ( Site 1506)
Kayseri, , Turkey (Türkiye)
Royal London Hospital-Dermatology Research Unit ( Site 1605)
London, England, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 1603)
Birmingham, Warwickshire, United Kingdom
New Cross Hospital ( Site 1601)
Wolverhampton, , United Kingdom
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2023-503502-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1287-4329
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-6194-007
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230622
Identifier Type: REGISTRY
Identifier Source: secondary_id
6194-007
Identifier Type: -
Identifier Source: org_study_id
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