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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 15, 29, 43, and 85: predose
Awards & highlights
Study Summary
This trial will test the safety and tolerability of the drug MK-6194 in people with moderate to severe atopic dermatitis who haven't responded to 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.Check my eligibility
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.See study design
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.
Select...
I have been diagnosed with atopic dermatitis for at least 6 months.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Discontinue Study Intervention Due to an AE
Number of Participants who Experience One or More Adverse Events (AEs)
Secondary outcome measures
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
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,499 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,408 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical participants are being enrolled in this research project?
"Indeed, the information available on clinicaltrials.gov makes it clear that this particular trial is still open for recruitment. This trial was first posted on 8/8/2022 and was most recently updated on 10/28/2022. In total, the study needs 72 patients from 6 different sites."
Answered by AI
If a patient is over 20, does that make them automatically ineligible for the trial?
"Enrolment into this study is restricted to patients aged 18 to 75. There are one hundred and one trials for patients younger than 18 and one hundred and sixty-eight for patients over the age of 65."
Answered by AI
Is there a risk of long-term adverse effects from taking MK-6194?
"As this is a Phase 1 trial, there is limited data supporting the safety of MK-6194. Our team scored it a 1."
Answered by AI
Are patients presently being signed up for this study?
"The trial is actively recruiting patients, as indicated by clinicaltrials.gov. The study was first posted on 8/8/2022 and was last updated on 10/28/2022. They are looking for a total of 72 patients that will be seen at 6 sites."
Answered by AI
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