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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 belowSelect...
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:Select...
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
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 moreTrial 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
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.
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.
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,019 Previous Clinical Trials
5,186,435 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,892 Previous Clinical Trials
8,089,250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had serious heart issues, stroke, or uncontrolled diabetes or blood pressure in the last 6 months.I have had a severe shingles outbreak or a widespread herpes infection recently.I am on long-term medication for a chronic infection.I have not received a live vaccine in the last 4 weeks and won't during the study.My major organs are stable and well-managed.I have had cancer before, but it was either skin cancer treated successfully, cervical carcinoma in situ, or another type that was treated and is now under control.I haven't had major surgery in the last 3 months and don't plan to during the study.My skin condition is moderate to severe.My skin condition didn't improve after using strong skin creams for over a month.I have received an organ or tissue transplant from another person.Your body mass index (BMI) should be between 18 and 38.I do not have significant skin conditions other than atopic dermatitis.I have been diagnosed with atopic dermatitis for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Panel D
- Group 2: Dose Escalation Panel A
- Group 3: Expansion Panel E
- Group 4: Dose Escalation Panel B
- Group 5: Dose Escalation Panel C
- Group 6: Expansion Dose F
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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