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

Last updated: March 27, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

2

Condition

Vitiligo

Treatment

Placebo

MK-6194

Clinical Study ID

NCT06113328
6194-007
U1111-1287-4329
2023-503502-37
2023-503502-37-00
jRCT2031230622
MK-6194-007
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) ≥ 0.3at 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 feetinvolvement

Exclusion

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 theopinion of the investigator, could interfere with the evaluation of vitiligo

  • Has a known systemic hypersensitivity to interleukin 2 (IL-2), or modified IL-2including MK-6194, or its inactive ingredients

  • Has an active or clinically significant infection requiring hospitalization ortreatment with IV anti-infectives within 4 weeks prior to Randomization, ororal/intramuscular anti-infective therapy within 2 weeks prior to Randomization

  • Has symptomatic heart failure (New York Heart Association class III or IV) ormyocardial 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 skincancer 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 surgeryplanned during the study

  • Has had an inadequate response (as evaluated by a dermatologist or local physicianspecialist 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 toRandomization

  • Has participated in another investigational clinical study within 4 weeks prior toRandomization

  • Has donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks prior tothe Screening Visit

  • Has received cosmetic or other procedures that could interfere with evaluation ofvitiligo during the study

Study Design

Total Participants: 169
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 27, 2023
Estimated Completion Date:
October 16, 2025

Connect with a study center

  • Psoriahue ( Site 0205)

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG
    Argentina

    Site Not Available

  • Stat Research S.A. ( Site 0204)

    Buenos Aires, Caba C1023AAB
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203)

    Ciudad Autónoma de Buenos Aires, Caba C1027AAP
    Argentina

    Site Not Available

  • Instituto Medico Strusberg ( Site 0208)

    Córdoba, Cordoba X5000EDC
    Argentina

    Site Not Available

  • Hospital Aleman-Dermatologia ( Site 0209)

    Buenos Aires, C1118AAT
    Argentina

    Site Not Available

  • Paratus Clinical Research Woden ( Site 1703)

    Phillip, Australian Capital Territory 2606
    Australia

    Site Not Available

  • Westmead Hospital-Dermatology ( Site 1701)

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Skin Health Institute Inc.-Trials ( Site 1702)

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Sinclair Dermatology ( Site 1704)

    Melbourne, Victoria 3002
    Australia

    Site Not Available

  • UZ Gent ( Site 0604)

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Leuven ( Site 0601)

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Enverus Medical Research ( Site 0006)

    Surrey, British Columbia V3V 0C6
    Canada

    Site Not Available

  • Diex Recherche sherbrooke Inc. ( Site 0007)

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Centre de Recherche Dermatologique du Quebec metropolitain ( Site 0002)

    Quebec, G1V 4X7
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc. ( Site 0008)

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Dermisur ( Site 0305)

    Osorno, Los Lagos 5310644
    Chile

    Site Not Available

  • Clinical Research Chile SpA ( Site 0304)

    Valdivia, Los Rios 5110683
    Chile

    Site Not Available

  • Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)

    Santiago, Region M. De Santiago 8420383
    Chile

    Site Not Available

  • Clinica Dermacross ( Site 0301)

    Santiago, Region M. De Santiago 7640881
    Chile

    Site Not Available

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0308)

    Santiago, Region M. De Santiago 8330034
    Chile

    Site Not Available

  • CliniSalud ( Site 0401)

    Envigado, Antioquia 055422
    Colombia

    Site Not Available

  • IPS SURA San Diego ( Site 0408)

    Medellín, Antioquia 50016
    Colombia

    Site Not Available

  • Centro Integral de Reumatología del Caribe ( Site 0405)

    Barranquilla, Atlantico 080002
    Colombia

    Site Not Available

  • Healthy Medical Center S.A.S ( Site 0403)

    Zipaquira, Cundinamarca 250252
    Colombia

    Site Not Available

  • Fundación Valle del Lili ( Site 0412)

    Cali, Valle Del Cauca 760032
    Colombia

    Site Not Available

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0803)

    Nice, Alpes-Maritimes 06202
    France

    Site Not Available

  • CHU de Bordeaux Hop St ANDRE ( Site 0804)

    Bordeaux, Aquitaine 33075
    France

    Site Not Available

  • Hôpital Edouard Herriot ( Site 0802)

    Lyon, Rhone-Alpes 69003
    France

    Site Not Available

  • HENRI MONDOR HOSPITAL ( Site 0801)

    Creteil, Val-de-Marne 94000
    France

    Site Not Available

  • HENRI MONDOR HOSPITAL ( Site 0801)

    Créteil, Val-de-Marne 94000
    France

    Site Not Available

  • Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905)

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Universitätsklinikum Münster-Hautklinik ( Site 0904)

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)

    Berlin, 10117
    Germany

    Site Not Available

  • Rambam Health Care Campus-Dermatology ( Site 1002)

    Haifa, 3109601
    Israel

    Site Not Available

  • Sheba Medical Center-Dermatology ( Site 1001)

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Nagoya City University Hospital-Dermatology ( Site 2002)

    Nagoya, Aichi 467-8602
    Japan

    Site Not Available

  • Osaka University Hospital ( Site 2004)

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Tokyo Medical University Hospital ( Site 2001)

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Inha University Hospital ( Site 1992)

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital-Dermatology ( Site 1991)

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System-Department of Dermatology ( Site 1993)

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Cryptex Investigación Clínica S.A. de C.V. ( Site 0515)

    Cuauhtémoc, Ciudad De México, Distrito Federal 06100
    Mexico

    Site Not Available

  • Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0504)

    Monterrey, Nuevo Leon 64460
    Mexico

    Site Not Available

  • Centro de Atención e Investigación Clínica ( Site 0507)

    Aguascalientes, 20129
    Mexico

    Site Not Available

  • Amsterdam UMC, locatie AMC-Dermatology ( Site 1101)

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Hospital Universitario Puerta del Mar ( Site 1302)

    Cádiz, Andalucia 11009
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge-Dermatology ( Site 1307)

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Clinica Universidad de Navarra ( Site 1305)

    Madrid, Madrid, Comunidad De 28027
    Spain

    Site Not Available

  • Cantonal Hospital St.Gallen ( Site 1402)

    St.Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • UniversitätsSpital Zürich ( Site 1401)

    Zürich, Zurich 8091
    Switzerland

    Site Not Available

  • Hacettepe Universite Hastaneleri-Dermatology ( Site 1501)

    Altindağ, Ankara 06230
    Turkey

    Site Not Available

  • Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)

    Ankara, 06800
    Turkey

    Site Not Available

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri-Dermatology and Venereology ( Site 1506)

    Kayseri, 38039
    Turkey

    Site Not Available

  • Royal London Hospital-Dermatology Research Unit ( Site 1605)

    London, England E1 1BB
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital Birmingham ( Site 1603)

    Birmingham, Warwickshire B15 2TH
    United Kingdom

    Site Not Available

  • New Cross Hospital ( Site 1601)

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Cahaba Dermatology & Skin Health Center ( Site 0127)

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Burke Pharmaceutical Research ( Site 0124)

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • The Vitiligo & Pigmentation Institute of Southern California ( Site 0115)

    Los Angeles, California 90036
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC ( Site 0106)

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Indiana University Health University Hospital-Indiana University School of Medicine, Department of (

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Metro Boston Clinical Partners ( Site 0110)

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Hamzavi Dermatology - Canton ( Site 0101)

    Canton, Michigan 48187
    United States

    Site Not Available

  • Remington Davis Clinical Research-Outpatient ( Site 0104)

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Medical University of South Carolina-Dermatology Research ( Site 0114)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • International Clinical Research - Tennessee LLC ( Site 0120)

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Progressive Clinical Research ( Site 0108)

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Virginia Clinical Research, Inc. ( Site 0109)

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Dermatology Specialists of Spokane ( Site 0126)

    Spokane, Washington 99202
    United States

    Site Not Available

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