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

NCT06113328 | Terminated Phase 2 Results DMC FDA Drug

• 5 other identifiers: 6194-0072023-503502-37-00U1111-1287-4329MK-6194-007jRCT2031230622
• Study Type: interventional
• Target: 169
• Locations: 18 countries
• Sites: 68

Brief 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.

Conditions

Non-segmental Vitiligo

Outcome Measures

Primary Outcomes (3)

• Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24

  VASI is a validated scoring method that measures the extent and severity of vitiligo depigmentation. The F-VASI measures vitiligo involvement of the facial area. For facial lesions, size is estimated using fingertip units (FTU), fingers, or thumbs: 1 FTU is approximately 0.03% body surface area (BSA), while a finger or thumb is approximately 0.1% BSA. Depigmentation at each site is graded to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. F-VASI is calculated by multiplying the area (in FTUs) by the depigmentation percentage for each facial site and summing the values. Scores range from 0 to approximately 3.5, with higher scores indicating greater vitiligo involvement of the facial area (more severe depigmentation). Percent change from baseline calculated as post-baseline value minus baseline value, divided by baseline value and multiplied by 100%. Longitudinal data analysis (LDA) model-based least squares mean (LSM) percent change from baseline to Week 24 was reported.

  Baseline and Week 24

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who experienced an AE is reported.

  Up to approximately 28 weeks

• Number of Participants Who Discontinued Study Treatment Due to an AE

  An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here.

  Up to approximately 24 weeks

Secondary Outcomes (1)

• Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

  Baseline and Week 24

Study Arms (7)

MK-6194 3 mg Q2W

EXPERIMENTAL

Participants will receive subcutaneous (SC) MK-6194 3 mg every two weeks (Q2W).

Biological: MK-6194

MK-6194 3 mg Q4W

EXPERIMENTAL

Participants will receive SC MK-6194 3 mg every four weeks (Q4W).

Biological: MK-6194

Placebo

PLACEBO COMPARATOR

Participants will receive SC Placebo Q2W.

Drug: Placebo

MK-6194 3 mg Q2W (double-blind) / MK-6194 3 mg Q2W (extension)

EXPERIMENTAL

After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q2W in the Double-Blind Treatment Period, participants will continue to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.

Biological: MK-6194

MK-6194 3 mg Q4W (double-blind) / MK-6194 3 mg Q4W (extension)

EXPERIMENTAL

After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q4W in the Double-Blind Treatment Period, participants will continue to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.

Biological: MK-6194

Placebo (double-blind)/ MK-6194 3 mg Q2W (extension)

EXPERIMENTAL

After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants will be re-randomized to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.

Biological: MK-6194

Placebo (double-blind)/ MK-6194 3 mg Q4W (extension)

EXPERIMENTAL

After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants will be re-randomized to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.

Biological: MK-6194

Interventions

MK-6194 BIOLOGICAL

MK-6194 administered subcutaneously (SC)

MK-6194 3 mg Q2W; MK-6194 3 mg Q2W (double-blind) / MK-6194 3 mg Q2W (extension); MK-6194 3 mg Q4W; MK-6194 3 mg Q4W (double-blind) / MK-6194 3 mg Q4W (extension); Placebo (double-blind)/ MK-6194 3 mg Q2W (extension); Placebo (double-blind)/ MK-6194 3 mg Q4W (extension)

Placebo DRUG

Placebo comparator to MK-6194 administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (68)

Cahaba Dermatology & Skin Health Center ( Site 0127)

Birmingham, Alabama, 35244, United States

Location

Burke Pharmaceutical Research ( Site 0124)

Hot Springs, Arkansas, 71913, United States

Location

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

Los Angeles, California, 90036, United States

Location

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

Indianapolis, Indiana, 46202, United States

Location

Dawes Fretzin Clinical Research Group, LLC ( Site 0106)

Indianapolis, Indiana, 46250, United States

Location

Metro Boston Clinical Partners ( Site 0110)

Brighton, Massachusetts, 02135, United States

Location

Hamzavi Dermatology - Canton ( Site 0101)

Canton, Michigan, 48187, United States

Location

Remington Davis Clinical Research-Outpatient ( Site 0104)

Columbus, Ohio, 43215, United States

Location

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

Charleston, South Carolina, 29425, United States

Location

International Clinical Research - Tennessee LLC ( Site 0120)

Murfreesboro, Tennessee, 37130, United States

Location

Progressive Clinical Research ( Site 0108)

San Antonio, Texas, 78213, United States

Location

Virginia Clinical Research, Inc. ( Site 0109)

Norfolk, Virginia, 23502, United States

Location

Dermatology Specialists of Spokane ( Site 0126)

Spokane, Washington, 99202, United States

Location

Psoriahue ( Site 0205)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKG, Argentina

Location

Stat Research S.A. ( Site 0204)

Buenos Aires, Buenos Aires F.D., C1023AAB, Argentina

Location

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

Buenos Aires, Buenos Aires F.D., C1027AAP, Argentina

Location

Instituto Medico Strusberg ( Site 0208)

Córdoba, Córdoba Province, X5000EDC, Argentina

Location

Hospital Aleman-Dermatologia ( Site 0209)

Buenos Aires, C1118AAT, Argentina

Location

Paratus Clinical Research Woden ( Site 1703)

Phillip, Australian Capital Territory, 2606, Australia

Location

Westmead Hospital-Dermatology ( Site 1701)

Westmead, New South Wales, 2145, Australia

Location

Skin Health Institute Inc.-Trials ( Site 1702)

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology ( Site 1704)

Melbourne, Victoria, 3002, Australia

Location

UZ Gent ( Site 0604)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven ( Site 0601)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Enverus Medical Research ( Site 0006)

Surrey, British Columbia, V3V 0C6, Canada

Location

Diex Recherche Quebec Inc. ( Site 0008)

Québec, Quebec, G1V 4T3, Canada

Location

Centre de Recherche Dermatologique du Quebec metropolitain ( Site 0002)

Québec, Quebec, G1V 4X7, Canada

Location

Diex Recherche sherbrooke Inc. ( Site 0007)

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Dermisur ( Site 0305)

Osorno, Los Lagos Region, 5310644, Chile

Location

Clinical Research Chile SpA ( Site 0304)

Valdivia, Los Ríos Region, 5110683, Chile

Location

Clinica Dermacross ( Site 0301)

Santiago, Region M. de Santiago, 7640881, Chile

Location

Pontificia Universidad Catolica de Chile-CICUC ( Site 0308)

Santiago, Region M. de Santiago, 8330034, Chile

Location

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

Santiago, Region M. de Santiago, 8420383, Chile

Location

CliniSalud ( Site 0401)

Envigado, Antioquia, 055422, Colombia

Location

IPS SURA San Diego ( Site 0408)

Medellín, Antioquia, 50016, Colombia

Location

Centro Integral de Reumatología del Caribe ( Site 0405)

Barranquilla, Atlántico, 080002, Colombia

Location

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

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Fundación Valle del Lili ( Site 0412)

Cali, Valle del Cauca Department, 760032, Colombia

Location

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

Nice, Alpes-Maritimes, 06202, France

Location

CHU de Bordeaux Hop St ANDRE ( Site 0804)

Bordeaux, Aquitaine, 33075, France

Location

Hôpital Edouard Herriot ( Site 0802)

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

HENRI MONDOR HOSPITAL ( Site 0801)

Créteil, Val-de-Marne, 94000, France

Location

Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905)

Erlangen, Bavaria, 91054, Germany

Location

Universitätsklinikum Münster-Hautklinik ( Site 0904)

Münster, North Rhine-Westphalia, 48149, Germany

Location

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)

Berlin, 10117, Germany

Location

Rambam Health Care Campus-Dermatology ( Site 1002)

Haifa, 3109601, Israel

Location

Sheba Medical Center-Dermatology ( Site 1001)

Ramat Gan, 5265601, Israel

Location

Nagoya City University Hospital-Dermatology ( Site 2002)

Nagoya, Aichi-ken, 467-8602, Japan

Location

Osaka University Hospital ( Site 2004)

Suita, Osaka, 565-0871, Japan

Location

Tokyo Medical University Hospital ( Site 2001)

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

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

Cuauhtémoc, Ciudad de México, Mexico City, 06100, Mexico

Location

Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0504)

Monterrey, Nuevo León, 64460, Mexico

Location

Centro de Atención e Investigación Clínica ( Site 0507)

Aguascalientes, 20129, Mexico

Location

Amsterdam UMC, locatie AMC-Dermatology ( Site 1101)

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Inha University Hospital ( Site 1992)

Incheon, 22332, South Korea

Location

Seoul National University Hospital-Dermatology ( Site 1991)

Seoul, 03080, South Korea

Location

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

Seoul, 03722, South Korea

Location

Hospital Universitario Puerta del Mar ( Site 1302)

Cadiz, Andalusia, 11009, Spain

Location

Hospital Universitari de Bellvitge-Dermatology ( Site 1307)

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Clinica Universidad de Navarra ( Site 1305)

Madrid, Madrid, Comunidad de, 28027, Spain

Location

Cantonal Hospital St.Gallen ( Site 1402)

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

UniversitätsSpital Zürich ( Site 1401)

Zurich, Canton of Zurich, 8091, Switzerland

Location

Hacettepe Universite Hastaneleri-Dermatology ( Site 1501)

Altindağ, Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)

Ankara, 06800, Turkey (Türkiye)

Location

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

Kayseri, 38039, Turkey (Türkiye)

Location

Royal London Hospital-Dermatology Research Unit ( Site 1605)

London, England, E1 1BB, United Kingdom

Location

Queen Elizabeth Hospital Birmingham ( Site 1603)

Birmingham, Warwickshire, B15 2TH, United Kingdom

Location

New Cross Hospital ( Site 1601)

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 27, 2023
• Primary Completion: March 20, 2025
• Study Completion: July 30, 2025
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); GB (3); KR (3); JP (3); BE (2); IL (2); CO (5); US (13); CA (4); FR (4); DE (3); ES (3); AU (4); CH (2); ME (3); AR (5); CL (5); TU (3)