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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of MK-6194 in participants with non-segmental vitiligo. The primary hypothesis is that at least 1 MK-6194 dose is superior to placebo with regards to percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24.

Official Title
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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

Conditions
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Non-segmental Vitiligo

Intervention / Treatment
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* Biological: MK-6194
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 clinically significant infection, or any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to Randomization, or any infection requiring 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Base Study: Dose 1<br>Participants receive subcutaneous (SC) MK-6194 dose regimen 1. | Biological: MK-6194<br>* MK-6194 administered subcutaneously (SC)<br>|
| Experimental: Base Study: Dose 2<br>Participants receive SC MK-6194 dose regimen 2. | Biological: MK-6194<br>* MK-6194 administered subcutaneously (SC)<br>Drug: Placebo<br>* Placebo comparator to MK-6194 administered SC<br>|
| Placebo Comparator: Base Study: Placebo<br>Participants receive an SC placebo regimen. | Drug: Placebo<br>* Placebo comparator to MK-6194 administered SC<br>|
| Experimental: Extension: Dose 1<br>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. | Biological: MK-6194<br>* MK-6194 administered subcutaneously (SC)<br>|
| Experimental: Extension: Dose 2<br>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. | Biological: MK-6194<br>* MK-6194 administered subcutaneously (SC)<br>Drug: Placebo<br>* Placebo comparator to MK-6194 administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at 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. | Baseline and Week 24 | 
| Number of Participants Who Experience 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. | Up to approximately 24 weeks | 
| Number of Participants Who Discontinue 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. | Up to approximately 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at 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. | Baseline and Week 24 |