Phase
Condition
Vitiligo
Treatment
Placebo
MK-6194
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Psoriahue ( Site 0205)
Ciudad Autonoma de Buenos Aires, Buenos Aires C1425DKG
ArgentinaSite Not Available
Stat Research S.A. ( Site 0204)
Buenos Aires, Caba C1023AAB
ArgentinaSite Not Available
Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203)
Ciudad Autónoma de Buenos Aires, Caba C1027AAP
ArgentinaSite Not Available
Instituto Medico Strusberg ( Site 0208)
Córdoba, Cordoba X5000EDC
ArgentinaSite Not Available
Hospital Aleman-Dermatologia ( Site 0209)
Buenos Aires, C1118AAT
ArgentinaSite Not Available
Paratus Clinical Research Woden ( Site 1703)
Phillip, Australian Capital Territory 2606
AustraliaSite Not Available
Westmead Hospital-Dermatology ( Site 1701)
Westmead, New South Wales 2145
AustraliaSite Not Available
Skin Health Institute Inc.-Trials ( Site 1702)
Carlton, Victoria 3053
AustraliaSite Not Available
Sinclair Dermatology ( Site 1704)
Melbourne, Victoria 3002
AustraliaSite Not Available
UZ Gent ( Site 0604)
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Leuven ( Site 0601)
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
Enverus Medical Research ( Site 0006)
Surrey, British Columbia V3V 0C6
CanadaSite Not Available
Diex Recherche sherbrooke Inc. ( Site 0007)
Sherbrooke, Quebec J1L 0H8
CanadaSite Not Available
Centre de Recherche Dermatologique du Quebec metropolitain ( Site 0002)
Quebec, G1V 4X7
CanadaSite Not Available
Diex Recherche Quebec Inc. ( Site 0008)
Quebec, G1V 4T3
CanadaSite Not Available
Dermisur ( Site 0305)
Osorno, Los Lagos 5310644
ChileSite Not Available
Clinical Research Chile SpA ( Site 0304)
Valdivia, Los Rios 5110683
ChileSite Not Available
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
Santiago, Region M. De Santiago 8420383
ChileSite Not Available
Clinica Dermacross ( Site 0301)
Santiago, Region M. De Santiago 7640881
ChileSite Not Available
Pontificia Universidad Catolica de Chile-CICUC ( Site 0308)
Santiago, Region M. De Santiago 8330034
ChileSite Not Available
CliniSalud ( Site 0401)
Envigado, Antioquia 055422
ColombiaSite Not Available
IPS SURA San Diego ( Site 0408)
Medellín, Antioquia 50016
ColombiaSite Not Available
Centro Integral de Reumatología del Caribe ( Site 0405)
Barranquilla, Atlantico 080002
ColombiaSite Not Available
Healthy Medical Center S.A.S ( Site 0403)
Zipaquira, Cundinamarca 250252
ColombiaSite Not Available
Fundación Valle del Lili ( Site 0412)
Cali, Valle Del Cauca 760032
ColombiaSite Not Available
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0803)
Nice, Alpes-Maritimes 06202
FranceSite Not Available
CHU de Bordeaux Hop St ANDRE ( Site 0804)
Bordeaux, Aquitaine 33075
FranceSite Not Available
Hôpital Edouard Herriot ( Site 0802)
Lyon, Rhone-Alpes 69003
FranceSite Not Available
HENRI MONDOR HOSPITAL ( Site 0801)
Creteil, Val-de-Marne 94000
FranceSite Not Available
HENRI MONDOR HOSPITAL ( Site 0801)
Créteil, Val-de-Marne 94000
FranceSite Not Available
Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905)
Erlangen, Bayern 91054
GermanySite Not Available
Universitätsklinikum Münster-Hautklinik ( Site 0904)
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)
Berlin, 10117
GermanySite Not Available
Rambam Health Care Campus-Dermatology ( Site 1002)
Haifa, 3109601
IsraelSite Not Available
Sheba Medical Center-Dermatology ( Site 1001)
Ramat Gan, 5265601
IsraelSite Not Available
Nagoya City University Hospital-Dermatology ( Site 2002)
Nagoya, Aichi 467-8602
JapanSite Not Available
Osaka University Hospital ( Site 2004)
Suita, Osaka 565-0871
JapanSite Not Available
Tokyo Medical University Hospital ( Site 2001)
Shinjuku-ku, Tokyo 160-0023
JapanSite Not Available
Inha University Hospital ( Site 1992)
Incheon, 22332
Korea, Republic ofSite Not Available
Seoul National University Hospital-Dermatology ( Site 1991)
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System-Department of Dermatology ( Site 1993)
Seoul, 03722
Korea, Republic ofSite Not Available
Cryptex Investigación Clínica S.A. de C.V. ( Site 0515)
Cuauhtémoc, Ciudad De México, Distrito Federal 06100
MexicoSite Not Available
Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0504)
Monterrey, Nuevo Leon 64460
MexicoSite Not Available
Centro de Atención e Investigación Clínica ( Site 0507)
Aguascalientes, 20129
MexicoSite Not Available
Amsterdam UMC, locatie AMC-Dermatology ( Site 1101)
Amsterdam, Noord-Holland 1105 AZ
NetherlandsSite Not Available
Hospital Universitario Puerta del Mar ( Site 1302)
Cádiz, Andalucia 11009
SpainSite Not Available
Hospital Universitari de Bellvitge-Dermatology ( Site 1307)
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Clinica Universidad de Navarra ( Site 1305)
Madrid, Madrid, Comunidad De 28027
SpainSite Not Available
Cantonal Hospital St.Gallen ( Site 1402)
St.Gallen, Sankt Gallen 9007
SwitzerlandSite Not Available
UniversitätsSpital Zürich ( Site 1401)
Zürich, Zurich 8091
SwitzerlandSite Not Available
Hacettepe Universite Hastaneleri-Dermatology ( Site 1501)
Altindağ, Ankara 06230
TurkeySite Not Available
Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)
Ankara, 06800
TurkeySite Not Available
Erciyes Universitesi Tıp Fakultesi Hastaneleri-Dermatology and Venereology ( Site 1506)
Kayseri, 38039
TurkeySite Not Available
Royal London Hospital-Dermatology Research Unit ( Site 1605)
London, England E1 1BB
United KingdomSite Not Available
Queen Elizabeth Hospital Birmingham ( Site 1603)
Birmingham, Warwickshire B15 2TH
United KingdomSite Not Available
New Cross Hospital ( Site 1601)
Wolverhampton, WV10 0QP
United KingdomSite Not Available
Cahaba Dermatology & Skin Health Center ( Site 0127)
Birmingham, Alabama 35244
United StatesSite Not Available
Burke Pharmaceutical Research ( Site 0124)
Hot Springs, Arkansas 71913
United StatesSite Not Available
The Vitiligo & Pigmentation Institute of Southern California ( Site 0115)
Los Angeles, California 90036
United StatesSite Not Available
Dawes Fretzin Clinical Research Group, LLC ( Site 0106)
Indianapolis, Indiana 46250
United StatesSite Not Available
Indiana University Health University Hospital-Indiana University School of Medicine, Department of (
Indianapolis, Indiana 46202
United StatesSite Not Available
Metro Boston Clinical Partners ( Site 0110)
Brighton, Massachusetts 02135
United StatesSite Not Available
Hamzavi Dermatology - Canton ( Site 0101)
Canton, Michigan 48187
United StatesSite Not Available
Remington Davis Clinical Research-Outpatient ( Site 0104)
Columbus, Ohio 43215
United StatesSite Not Available
Medical University of South Carolina-Dermatology Research ( Site 0114)
Charleston, South Carolina 29425
United StatesSite Not Available
International Clinical Research - Tennessee LLC ( Site 0120)
Murfreesboro, Tennessee 37130
United StatesSite Not Available
Progressive Clinical Research ( Site 0108)
San Antonio, Texas 78213
United StatesSite Not Available
Virginia Clinical Research, Inc. ( Site 0109)
Norfolk, Virginia 23502
United StatesSite Not Available
Dermatology Specialists of Spokane ( Site 0126)
Spokane, Washington 99202
United StatesSite Not Available
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