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NCT06113328

PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

169

Start Date

2023-11-27

Completion Date

2025-07-30

Last Updated

2026-07-10

Healthy Volunteers

Conditions

Non-segmental Vitiligo

Interventions

BIOLOGICAL

MK-6194

MK-6194 administered subcutaneously (SC)

DRUG

Placebo

Placebo comparator to MK-6194 administered SC

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)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)