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NCT06113328

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

Terminated Phase 2 Results posted Last updated 17 March 2026
What this trial tests

Phase 2 trial testing MK-6194 in Non-segmental Vitiligo in 169 participants. Terminated before completion.

Timeline
27 November 2023
Primary endpoint
20 March 2025
30 July 2025

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment169
Start date27 November 2023
Primary completion20 March 2025
Estimated completion30 July 2025
Sites68 locations across France, Colombia, Japan, Netherlands, Belgium, Chile, United Kingdom, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-segmental Vitiligo. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 Primary · Baseline and 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 ran

GroupValue95% CI
MK-6194 3 mg Q2W-4.55-16.79 – 7.68
MK-6194 3 mg Q4W-12.13-24.29 – 0.03
Placebo-4.01-15.70 – 7.69
Number of Participants Who Experienced an Adverse Event (AE) Primary · Up to approximately 28 weeks

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.

GroupValue95% CI
MK-6194 3 mg Q2W51
MK-6194 3 mg Q4W47
Placebo44
Number of Participants Who Discontinued Study Treatment Due to an AE Primary · Up to approximately 24 weeks

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.

GroupValue95% CI
MK-6194 3 mg Q2W9
MK-6194 3 mg Q4W5
Placebo1
Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 Secondary · Baseline and 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. Sc

GroupValue95% CI
MK-6194 3 mg Q2W-1.69-11.02 – 7.65
MK-6194 3 mg Q4W-9.08-18.24 – 0.08
Placebo0.78-7.77 – 9.34

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 61 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MK-6194 3 mg Q2W
Serious: 3/57 (5%)
Deaths: 0/57
MK-6194 3 mg Q4W
Serious: 3/55 (5%)
Deaths: 0/55
Placebo
Serious: 0/57 (0%)
Deaths: 0/57
MK-6194 3 mg Q2W (Double-blind) / MK-6194 3 mg Q2W (Extension)
Serious: 0/34 (0%)
Deaths: 0/34
MK-6194 3 mg Q4W (Double-blind) / MK-6194 3 mg Q4W (Extension)
Serious: 0/43 (0%)
Deaths: 0/43
Placebo (Double-blind) / MK-6194 3 mg Q2W (Extension)
Serious: 0/27 (0%)
Deaths: 0/27
Placebo (Double-blind) / MK-6194 3 mg Q4W (Extension)
Serious: 1/26 (4%)
Deaths: 0/26

Serious adverse events (7 terms)

ReactionSystemMK-6194 3 mg Q2WMK-6194 3 mg Q4WPlaceboMK-6194 3 mg Q2W (Double-b…MK-6194 3 mg Q4W (Double-b…Placebo (Double-blind) / M…Placebo (Double-blind) / M…
DiarrhoeaGastrointestinal disorders
Injection site rashGeneral disorders
AppendicitisInfections and infestations
Cartilage injuryInjury, poisoning and procedural complications
Tendon ruptureInjury, poisoning and procedural complications
Hepatic enzyme increasedInvestigations
Rash papularSkin and subcutaneous tissue disorders
Other adverse events (37 terms — click to expand)

ReactionSystemMK-6194 3 mg Q2WMK-6194 3 mg Q4WPlaceboMK-6194 3 mg Q2W (Double-b…MK-6194 3 mg Q4W (Double-b…Placebo (Double-blind) / M…Placebo (Double-blind) / M…
Injection site erythemaGeneral disorders
Injection site reactionGeneral disorders
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
Injection site pruritusGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Injection site painGeneral disorders
Eosinophil count increasedInvestigations
Injection site swellingGeneral disorders
Injection site indurationGeneral disorders
COVID-19Infections and infestations
Accidental overdoseInjury, poisoning and procedural complications
MyalgiaMusculoskeletal and connective tissue disorders
PruritusSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
EosinophiliaBlood and lymphatic system disorders
Abdominal painGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
NauseaGastrointestinal disorders
FatigueGeneral disorders
Injection site rashGeneral disorders
InfluenzaInfections and infestations
Influenza like illnessGeneral disorders
Injection site bruisingGeneral disorders
Injection site hypersensitivityGeneral disorders
GastroenteritisInfections and infestations
Upper respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
Alanine aminotransferase increasedInvestigations
Back painMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
UrticariaSkin and subcutaneous tissue disorders
Injection site urticariaGeneral disorders
ConjunctivitisInfections and infestations
EczemaSkin and subcutaneous tissue disorders
ErythemaSkin and subcutaneous tissue disorders

Most-reported serious reactions: Diarrhoea, Injection site rash, Appendicitis, Cartilage injury, Tendon rupture, Hepatic enzyme increased, Rash papular.

Data from ClinicalTrials.gov NCT06113328 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Up-and-Coming Drugs for the Treatment of Vitiligo.
    Seong SH, Oh SH. · · 2024 · cited 8× · PMID 39082655 · DOI 10.5021/ad.24.038
  2. Emerging Therapeutic Innovations for Vitiligo Treatment.
    Li W, Dong P, Zhang G, Hu J, et al · · 2025 · cited 1× · PMID 40136446 · DOI 10.3390/cimb47030191

Verify or expand the search:

Other trials of MK-6194

Trials testing the same drug.

Other recruiting trials for Non-segmental Vitiligo

Currently open trials in the same condition.

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06113328.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing