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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-segmental Vitiligo

In brief

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.

Key facts

Study ID

NCT06113328

Run by

Merck Sharp & Dohme LLC

People needed

169

Starts

2023-11-27

Expected to finish

2025-07-30

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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)
• 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

Where it is running

• Burke Pharmaceutical Research ( Site 0124) — Hot Springs, Arkansas, United States
• The Vitiligo & Pigmentation Institute of Southern California ( Site 0115) — Los Angeles, California, United States
• Indiana University Health University Hospital-Indiana University School of Medicine, Department of ( — Indianapolis, Indiana, United States
• Dawes Fretzin Clinical Research Group, LLC ( Site 0106) — Indianapolis, Indiana, United States
• Metro Boston Clinical Partners ( Site 0110) — Brighton, Massachusetts, United States
• Hamzavi Dermatology - Canton ( Site 0101) — Canton, Michigan, United States
• Remington Davis Clinical Research-Outpatient ( Site 0104) — Columbus, Ohio, United States
• Medical University of South Carolina-Dermatology Research ( Site 0114) — Charleston, South Carolina, United States
• International Clinical Research - Tennessee LLC ( Site 0120) — Murfreesboro, Tennessee, United States
• Progressive Clinical Research ( Site 0108) — San Antonio, Texas, United States
• Virginia Clinical Research, Inc. ( Site 0109) — Norfolk, Virginia, United States
• Dermatology Specialists of Spokane ( Site 0126) — Spokane, Washington, United States
• Psoriahue ( Site 0205) — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Stat Research S.A. ( Site 0204) — Buenos Aires, Buenos Aires F.D., Argentina
• Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203) — Buenos Aires, Buenos Aires F.D., Argentina
• Instituto Medico Strusberg ( Site 0208) — Córdoba, Córdoba Province, Argentina
• Hospital Aleman-Dermatologia ( Site 0209) — Buenos Aires, Argentina
• Paratus Clinical Research Woden ( Site 1703) — Phillip, Australian Capital Territory, Australia
• Westmead Hospital-Dermatology ( Site 1701) — Westmead, New South Wales, Australia
• Skin Health Institute Inc.-Trials ( Site 1702) — Carlton, Victoria, Australia
• Sinclair Dermatology ( Site 1704) — Melbourne, Victoria, Australia
• UZ Gent ( Site 0604) — Ghent, Oost-Vlaanderen, Belgium
• UZ Leuven ( Site 0601) — Leuven, Vlaams-Brabant, Belgium
• Enverus Medical Research ( Site 0006) — Surrey, British Columbia, Canada
• Cahaba Dermatology & Skin Health Center ( Site 0127) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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