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The trial is taking place at:
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Centro Internacional de Estudios Clinicos | Santiago, Chile

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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling
Phase 2

Conditions

Non-segmental Vitiligo

Treatments

Biological: MK-6194
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06113328
MK-6194-007 (Other Identifier)
U1111-1287-4329 (Other Identifier)
6194-007
jRCT2031230622 (Registry Identifier)
2023-503502-37-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

165 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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) ≥ 0.3 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

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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

165 participants in 5 patient groups, including a placebo group

Base Study: Dose 1
Experimental group
Description:
Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
Treatment:
Biological: MK-6194
Base Study: Dose 2
Experimental group
Description:
Participants receive SC MK-6194 dose regimen 2.
Treatment:
Drug: Placebo
Biological: MK-6194
Base Study: Placebo
Placebo Comparator group
Description:
Participants receive an SC placebo regimen.
Treatment:
Drug: Placebo
Extension: Dose 1
Experimental group
Description:
Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Treatment:
Biological: MK-6194
Extension: Dose 2
Experimental group
Description:
Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
Treatment:
Drug: Placebo
Biological: MK-6194

Trial contacts and locations

53

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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