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Non-segmental VitiligoPhase 2NCT06113328

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

A Phase 2 study testing MK-6194 in people with Non-segmental Vitiligo, run by Merck Sharp & Dohme LLC at 68 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-segmental Vitiligo
What is being tested?
MK-6194
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
169 participants
Where
68 sitesin 18 countries
Study dates
27 Nov 2023to 30 Jul 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

68 sites in 18 countries.

68 sites in 18 countries

United States13 sites

  • Cahaba Dermatology & Skin Health Center ( Site 0127)

    Birmingham, Alabama, 35244

  • Metro Boston Clinical Partners ( Site 0110)

    Brighton, Massachusetts, 02135

  • Hamzavi Dermatology - Canton ( Site 0101)

    Canton, Michigan, 48187

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

    Charleston, South Carolina, 29425

  • Remington Davis Clinical Research-Outpatient ( Site 0104)

    Columbus, Ohio, 43215

  • Burke Pharmaceutical Research ( Site 0124)

    Hot Springs, Arkansas, 71913

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

    Indianapolis, Indiana, 46202

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

    Indianapolis, Indiana, 46250

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

    Los Angeles, California, 90036

  • International Clinical Research - Tennessee LLC ( Site 0120)

    Murfreesboro, Tennessee, 37130

  • Virginia Clinical Research, Inc. ( Site 0109)

    Norfolk, Virginia, 23502

  • Progressive Clinical Research ( Site 0108)

    San Antonio, Texas, 78213

  • Dermatology Specialists of Spokane ( Site 0126)

    Spokane, Washington, 99202

Other trials in United States

Argentina5 sites

  • Stat Research S.A. ( Site 0204)

    Buenos Aires, Buenos Aires F.D., C1023AAB

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

    Buenos Aires, Buenos Aires F.D., C1027AAP

  • Hospital Aleman-Dermatologia ( Site 0209)

    Buenos Aires, C1118AAT

  • Psoriahue ( Site 0205)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKG

  • Instituto Medico Strusberg ( Site 0208)

    Córdoba, Córdoba Province, X5000EDC

Other trials in Argentina

Chile5 sites

  • Dermisur ( Site 0305)

    Osorno, Los Lagos Region, 5310644

  • Clinica Dermacross ( Site 0301)

    Santiago, Region M. de Santiago, 7640881

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

    Santiago, Region M. de Santiago, 8330034

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

    Santiago, Region M. de Santiago, 8420383

  • Clinical Research Chile SpA ( Site 0304)

    Valdivia, Los Ríos Region, 5110683

Other trials in Chile

Colombia5 sites

  • Centro Integral de Reumatología del Caribe ( Site 0405)

    Barranquilla, Atlántico, 080002

  • Fundación Valle del Lili ( Site 0412)

    Cali, Valle del Cauca Department, 760032

  • CliniSalud ( Site 0401)

    Envigado, Antioquia, 055422

  • IPS SURA San Diego ( Site 0408)

    Medellín, Antioquia, 50016

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

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Australia4 sites

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

    Carlton, Victoria, 3053

  • Sinclair Dermatology ( Site 1704)

    Melbourne, Victoria, 3002

  • Paratus Clinical Research Woden ( Site 1703)

    Phillip, Australian Capital Territory, 2606

  • Westmead Hospital-Dermatology ( Site 1701)

    Westmead, New South Wales, 2145

Other trials in Australia

Canada4 sites

  • Diex Recherche Quebec Inc. ( Site 0008)

    Québec, Quebec, G1V 4T3

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

    Québec, Quebec, G1V 4X7

  • Diex Recherche sherbrooke Inc. ( Site 0007)

    Sherbrooke, Quebec, J1L 0H8

  • Enverus Medical Research ( Site 0006)

    Surrey, British Columbia, V3V 0C6

Other trials in Canada

France4 sites

  • CHU de Bordeaux Hop St ANDRE ( Site 0804)

    Bordeaux, Aquitaine, 33075

  • HENRI MONDOR HOSPITAL ( Site 0801)

    Créteil, Val-de-Marne, 94000

  • Hôpital Edouard Herriot ( Site 0802)

    Lyon, Auvergne-Rhône-Alpes, 69003

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

    Nice, Alpes-Maritimes, 06202

Other trials in France

Germany3 sites

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)

    Berlin, 10117

  • Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905)

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Münster-Hautklinik ( Site 0904)

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Japan3 sites

  • Nagoya City University Hospital-Dermatology ( Site 2002)

    Nagoya, Aichi-ken, 467-8602

  • Tokyo Medical University Hospital ( Site 2001)

    Shinjuku-ku, Tokyo, 160-0023

  • Osaka University Hospital ( Site 2004)

    Suita, Osaka, 565-0871

Other trials in Japan

Mexico3 sites

  • Centro de Atención e Investigación Clínica ( Site 0507)

    Aguascalientes, 20129

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

    Cuauhtémoc, Ciudad de México, Mexico City, 06100

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

    Monterrey, Nuevo León, 64460

Other trials in Mexico

South Korea3 sites

  • Inha University Hospital ( Site 1992)

    Incheon, 22332

  • Seoul National University Hospital-Dermatology ( Site 1991)

    Seoul, 03080

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

    Seoul, 03722

Other trials in South Korea

Spain3 sites

  • Hospital Universitario Puerta del Mar ( Site 1302)

    Cadiz, Andalusia, 11009

  • Hospital Universitari de Bellvitge-Dermatology ( Site 1307)

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Clinica Universidad de Navarra ( Site 1305)

    Madrid, Madrid, Comunidad de, 28027

Other trials in Spain

Turkey (Türkiye)3 sites

  • Hacettepe Universite Hastaneleri-Dermatology ( Site 1501)

    Altindağ, Ankara, 06230

  • Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)

    Ankara, 06800

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

    Kayseri, 38039

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Queen Elizabeth Hospital Birmingham ( Site 1603)

    Birmingham, Warwickshire, B15 2TH

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

    London, England, E1 1BB

  • New Cross Hospital ( Site 1601)

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Belgium2 sites

  • UZ Gent ( Site 0604)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven ( Site 0601)

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Israel2 sites

  • Rambam Health Care Campus-Dermatology ( Site 1002)

    Haifa, 3109601

  • Sheba Medical Center-Dermatology ( Site 1001)

    Ramat Gan, 5265601

Other trials in Israel

Switzerland2 sites

  • Cantonal Hospital St.Gallen ( Site 1402)

    Sankt Gallen, Canton of St. Gallen, 9007

  • UniversitätsSpital Zürich ( Site 1401)

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Netherlands1 site

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

    Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

About this study

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

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.

Read the detailed description

This study will consist of two periods. During the Double-Blind Treatment Period, participants will be randomized to one of three treatment arms to receive MK-6194 at one of two doses or placebo and will be evaluated for safety and efficacy. Participants who complete this period may enter the Blinded Extension Period, during which MK-6194 treatment will continue or placebo recipients will be re-randomized to MK-6194 at one of two doses.

Being tested
MK-6194, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-6194Biological

    MK-6194 administered subcutaneously (SC)

  • PlaceboDrug

    Placebo comparator to MK-6194 administered SC

Study groups in NCT06113328
Study groupRoleWhat they receive
MK-6194 3 mg Q2WExperimentalParticipants will receive subcutaneous (SC) MK-6194 3 mg every two weeks (Q2W).
Receives: Biological: MK-6194
MK-6194 3 mg Q4WExperimentalParticipants will receive SC MK-6194 3 mg every four weeks (Q4W).
Receives: Biological: MK-6194
PlaceboPlacebo comparatorParticipants will receive SC Placebo Q2W.
Receives: Drug: Placebo
MK-6194 3 mg Q2W (double-blind) / MK-6194 3 mg Q2W (extension)ExperimentalAfter 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.
Receives: Biological: MK-6194
MK-6194 3 mg Q4W (double-blind) / MK-6194 3 mg Q4W (extension)ExperimentalAfter 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.
Receives: Biological: MK-6194
Placebo (double-blind)/ MK-6194 3 mg Q2W (extension)ExperimentalAfter 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.
Receives: Biological: MK-6194
Placebo (double-blind)/ MK-6194 3 mg Q4W (extension)ExperimentalAfter 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.
Receives: Biological: MK-6194

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 24

  2. 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.

    Measured: Up to approximately 28 weeks

  3. 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.

    Measured: Up to approximately 24 weeks

Secondary outcomes (1)

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

    T-VASI is a validated scoring method that measures the extent and severity of vitiligo across the entire body. The body is divided into six regions: head/neck, hands, upper extremities, trunk, lower extremities, and feet. One hand unit (palm and fingers together) represents 1% of BSA. Depigmentation for each region is graded to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. For regions with multiple lesions, percentages are averaged. The T-VASI score is calculated by multiplying the area (in hand units) by the depigmentation percentage for each region and summing all regions. Scores range from 0 to 100, with 0 indicating no vitiligo and 100 indicating complete body involvement. Percent change from baseline calculated as post-baseline value minus baseline value, divided by baseline value and multiplied by 100%. LDA model-based LSM percent change from baseline to Week 24 was reported.

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start27 Nov 2023
  3. Primary completion20 Mar 2025
  4. Study completion30 Jul 2025

Why it stopped: Business Reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06113328
Sponsor's protocol ID
6194-007
Other IDs
2023-503502-37-00, U1111-1287-4329, MK-6194-007, jRCT2031230622, 2023
Status last verified
Jun 2026
First submitted
27 Oct 2023
Last updated
10 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-6194 in people with Non-segmental Vitiligo, run by Merck Sharp & Dohme LLC at 68 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Argentina, Chile, Colombia, Australia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 (time frame: Baseline and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06113328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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