What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, calcineurin inhibitors, and newer systemic treatments like JAK inhibitors and biologics. Topical corticosteroids can cause skin thinning, stretch marks, and systemic absorption leading to hormonal imbalances. Calcineurin inhibitors may cause burning sensations and increased risk of skin infections. JAK inhibitors, such as abrocitinib, can lead to nausea, acne, headache, and nasopharyngitis. Biologics like dupilumab may cause injection site reactions, conjunctivitis, and nasopharyngitis. Overall, these treatments are generally well-tolerated, but monitoring for adverse effects is essential.

What prior FDA approvals exist?

The FDA has approved several treatments for moderate to severe atopic dermatitis, particularly for cases unresponsive to other therapies. Notable among these is dupilumab, a biologic that has shown significant efficacy in reducing symptoms and improving quality of life. Topical treatments like tacrolimus and pimecrolimus have also been approved for their immunomodulatory effects. Additionally, crisaborole ointment, a non-steroidal topical treatment, has been approved for mild to moderate atopic dermatitis. These treatments focus on reducing inflammation and modulating the immune response, similar to the investigational drug MK-6194.

What other types of research exist?

Promising novel alternatives to MK-6194 for atopic dermatitis include crisaborole ointment, 2%, a non-steroidal phosphodiesterase 4 inhibitor, which has shown efficacy in reducing pruritus and has a favorable safety profile. Additionally, tacrolimus and pimecrolimus ointments are effective non-steroidal options for long-term management of AD, with studies supporting their safety and efficacy.

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Unknown

MK-6194 for Atopic Dermatitis

Phase 1

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

Atopic dermatitis is of at least moderate severity

Clinical diagnosis of atopic dermatitis for at least 6 months prior to the Screening visit

Must not have

History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening

History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 15, 29, 43, and 85: predose

Summary

This trial is testing a new treatment called MK-6194 to see if it is safe and tolerable for people with moderate to severe atopic dermatitis who haven't had success with other treatments.

Who is the study for?

This trial is for adults with moderate to severe atopic dermatitis (eczema) who haven't improved with standard treatments. They must have a stable weight (BMI between 18 and 38), been diagnosed with eczema for at least 6 months, and not responded well to strong skin creams or ointments recently.

What is being tested?

The study tests MK-6194's safety and how well it's tolerated when given multiple times to people with tough-to-treat eczema. Some participants will receive MK-6194, while others will get a placebo, which has no active drug in it.

What are the potential side effects?

While the specific side effects of MK-6194 are not detailed here, common side effects from drugs treating atopic dermatitis may include skin irritation or burning, itching, infections, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My skin condition is moderate to severe.

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I have been diagnosed with atopic dermatitis for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had serious heart issues, stroke, or uncontrolled diabetes or blood pressure in the last 6 months.

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I have had a severe shingles outbreak or a widespread herpes infection recently.

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I am on long-term medication for a chronic infection.

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I haven't had major surgery in the last 3 months and don't plan to during the study.

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I have received an organ or tissue transplant from another person.

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I do not have significant skin conditions other than atopic dermatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 15, 29, 43, and 85: predose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 15, 29, 43, and 85: predose

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 15, 29, 43, and 85: predose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants who Discontinue Study Intervention Due to an AE

Number of Participants who Experience One or More Adverse Events (AEs)

Secondary study objectives

AUC from Days 29-43 (AUC29-43) of MK-6194

Area Under the Curve (AUC) from Days 1-15 (AUC1-15) of MK-6194

Fold Change from Baseline in Peak Regulatory T cells (Tregs)

+5 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Expansion Panel EExperimental Treatment2 Interventions

Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.

Group II: Expansion Panel DExperimental Treatment2 Interventions

Participants are randomized to medium dose MK-6194 or placebo administered q2w.

Group III: Expansion Dose FExperimental Treatment2 Interventions

Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.

Group IV: Dose Escalation Panel CExperimental Treatment2 Interventions

Participants are randomized to high dose MK-6194 or placebo administered q2w.

Group V: Dose Escalation Panel BExperimental Treatment2 Interventions

Participants are randomized to medium dose MK-6194 or placebo administered q2w.

Group VI: Dose Escalation Panel AExperimental Treatment2 Interventions

Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).

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 / 8Eligibility 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 Atopic Dermatitis (AD) include systemic therapies like dupilumab and cyclosporine. Dupilumab is a monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are key drivers of the inflammatory response in AD. Cyclosporine, on the other hand, suppresses the immune system by inhibiting calcineurin, thereby reducing the activity of T-cells that contribute to inflammation. These treatments are significant for AD patients as they target the underlying immune dysregulation, providing relief from severe symptoms and improving the quality of life.

Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis.