A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
- Conditions
- Non-segmental Vitiligo
- Interventions
- Drug: Placebo
- Registration Number
- NCT06113328
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 169
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extension: Dose 2 Placebo 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. Extension: Dose 1 MK-6194 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. Base Study: Dose 2 Placebo Participants receive SC MK-6194 dose regimen 2. Base Study: Placebo Placebo Participants receive an SC placebo regimen. Base Study: Dose 1 MK-6194 Participants receive subcutaneous (SC) MK-6194 dose regimen 1. Base Study: Dose 2 MK-6194 Participants receive SC MK-6194 dose regimen 2. Extension: Dose 2 MK-6194 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.
- Primary Outcome Measures
Name Time Method Number of Participants Who Discontinue Study Treatment Due to an AE 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.
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 Baseline and Week 24 VASI is a validated scoring method that assesses the extent and severity of areas of vitiligo depigmentation. F-VASI will be calculated to indicate facial lesions, using the following scale: At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; and at 10%, only specks of depigmentation are present.
Number of Participants Who Experience an Adverse Event (AE) 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 Baseline and Week 24 VASI is a validated scoring method that assesses the extent and severity of areas of vitiligo depigmentation. T-VASI will be calculated to indicate all lesions on the body, using the following scale: At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; and at 10%, only specks of depigmentation are present.
Trial Locations
- Locations (68)
Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)
🇹🇷Ankara, Turkey
Cahaba Dermatology & Skin Health Center ( Site 0127)
🇺🇸Birmingham, Alabama, United States
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
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