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A clinical study of MK-6194 for the treatment of vitiligo (MK-6194-007)
EU CTIS ID: 2023-503502-37-00
What this study is testing
1. To evaluate the efficacy of MK-6194 on the percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 2. To evaluate the safety and tolerability of MK-6194
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 F-VASI ≥ 0.3 at screening and baseline
- Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline
- Has T-VASI ≥4 at screening and baseline
- Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement
You likely can't join if
- Has segmental vitiligo
- 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
See the full eligibility 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 F-VASI ≥ 0.3 at screening and baseline
- Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline
- Has T-VASI ≥4 at screening and baseline
- Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement
- Is 18 to 75 years of age inclusive at the time of providing informed consent
- Has segmental vitiligo
- 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
- 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 intravenous (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
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Australia
- Mexico
- Switzerland
- United States
- Chile
- Colombia
- United Kingdom
- Japan
- Korea, Republic of
- Canada
- Turkey
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Australia; Mexico; Switzerland; United States; Chile and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.