What side effects are associated with this type of intervention?

Common treatments for vitiligo that modulate immune response or affect melanocyte function include topical corticosteroids, calcineurin inhibitors, and biologics. Topical corticosteroids can cause skin thinning, stretch marks, and acne. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, may lead to burning or itching at the application site and have a potential risk of lymphoma with long-term use. Biologics, like those targeting specific immune pathways, can cause injection site reactions, increased risk of infections, and potential allergic reactions. It is important to discuss these side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, the FDA has approved only a few treatments specifically for vitiligo. One notable approval is for the topical Janus kinase (JAK) inhibitor ruxolitinib cream, which modulates the immune response and has shown efficacy in repigmenting skin in vitiligo patients. Other treatments, such as corticosteroids and calcineurin inhibitors, are used off-label to manage the condition by reducing inflammation and modulating the immune system. These treatments aim to restore pigmentation by affecting melanocyte function and the immune response, similar to the investigational drug MK-6194.

What other types of research exist?

Promising novel alternatives to MK-6194 for vitiligo treatment in 2024 include JAK inhibitors (e.g., ruxolitinib cream), which have shown efficacy in repigmentation by modulating the immune response, and afamelanotide, a melanocyte-stimulating agent that promotes pigmentation. Both treatments are currently being evaluated in clinical trials and have demonstrated potential in improving vitiligo symptoms.

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Monoclonal Antibodies

MK-6194 for Vitiligo

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has non-segmental vitiligo with disease duration of at least 6 months

Has a clinical diagnosis of non-segmental vitiligo

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 24

Summary

This trial is testing a new medication called MK-6194 to see if it can help people with non-segmental vitiligo. The goal is to determine if MK-6194 can reduce the white patches on their skin by helping repigment these areas. Researchers will compare the results over several months.

Who is the study for?

This trial is for individuals with non-segmental vitiligo, which causes loss of skin color in blotches. Participants must have had the condition for at least 6 months and show a certain amount of facial and body depigmentation. Those with hands and feet involvement or other forms of vitiligo are not eligible.

What is being tested?

The study tests MK-6194 against a placebo to see if it's better at improving the appearance of vitiligo on the face after 24 weeks. The main goal is to check how much this treatment can change the extent of skin color loss compared to no active treatment.

What are the potential side effects?

While specific side effects for MK-6194 aren't listed here, common ones in trials may include skin irritation, redness, itching or swelling where the drug is applied or taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have widespread vitiligo for more than 6 months.

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I have been diagnosed with non-segmental vitiligo.

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I have noticeable white patches on my face due to vitiligo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experience an Adverse Event (AE)

Secondary study objectives

Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Extension: Dose 2Experimental Treatment2 Interventions

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.

Group II: Extension: Dose 1Experimental Treatment1 Intervention

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.

Group III: Base Study: Dose 2Experimental Treatment2 Interventions

Participants receive SC MK-6194 dose regimen 2.

Group IV: Base Study: Dose 1Experimental Treatment1 Intervention

Participants receive subcutaneous (SC) MK-6194 dose regimen 1.

Group V: Base Study: PlaceboPlacebo Group1 Intervention

Participants receive an SC placebo regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

MK-6194

2022

Completed Phase 1

~150

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Vitiligo often aim to modulate the immune response or stimulate melanocyte function. For instance, corticosteroids and calcineurin inhibitors reduce inflammation and suppress the immune system, which can prevent further destruction of melanocytes. Treatments like phototherapy (narrowband UVB) stimulate melanocyte migration and proliferation, promoting repigmentation. Emerging treatments, such as JAK inhibitors, target specific pathways involved in the immune response, potentially offering more precise control over the disease. These mechanisms are crucial for Vitiligo patients as they address the underlying causes of depigmentation, aiming to restore skin color and improve quality of life.