Study

Overview

Official Title: 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

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.

Study Type:

Interventional

Study Phase:

Phase 2

Estimated Enrollment:

165

Study Start Date:

November 2023

Estimated Study Completion Date:

April 2026

Estimated Primary Completion Date:

September 2025

Eligibility

Ages Eligible for Study:

18 years to 75 years

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

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

Locations

United States Toll Free Number 1-800-770-4674

Birmingham, Alabama, 35244
Hot Springs, Arkansas, 71913
Los Angeles, California, 90036
Indianapolis, Indiana, 46202
Brighton, Massachusetts, 02135
Canton, Michigan, 48187
Columbus, Ohio, 43215
Charleston, South Carolina, 29425
Murfreesboro, Tennessee, 37130
San Antonio, Texas, 78213
Norfolk, Virginia, 23502

Canada Study Coordinator 1-418-650-0777

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-6194-007-00

Study Detail

A clinical study of MK-6194 for the treatment of vitiligo (MK-6194-007)