MK-6194 for Atopic Dermatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called MK-6194 for individuals with moderate to severe atopic dermatitis, a skin condition that causes itchy, inflamed patches. The goal is to assess the safety and tolerability of this treatment when used multiple times. Participants will receive either the treatment or a placebo (a harmless pill or injection with no effect) every two weeks in varying doses to determine the optimal one. Those who have had atopic dermatitis for at least six months and have not found relief from other treatments might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on chronic systemic anti-infective therapy for certain infections. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that MK-6194 is a new treatment under testing to assess its safety and tolerability. Earlier patients demonstrated that this treatment targets specific immune cells, potentially causing fewer side effects than other treatments.
Evidence from earlier studies remains limited because MK-6194 is still in early testing stages. The main goal of these studies is to determine its safety for humans. As this is an early-phase trial, researchers are still collecting safety information. A team closely monitors any side effects.
In summary, while MK-6194 is still under investigation, the early focus is on ensuring its safety and tolerability. More detailed safety results will become available as the study progresses.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for atopic dermatitis, which often include topical steroids and immunosuppressants, MK-6194 offers a novel approach. Researchers are excited about MK-6194 because it targets specific pathways involved in the inflammatory process, potentially leading to more effective management of symptoms. Additionally, MK-6194 is administered systematically every two weeks, which may enhance patient adherence and reduce the burden of daily treatment routines. This innovative approach could provide a valuable alternative for patients seeking more targeted and convenient options.
What evidence suggests that MK-6194 might be an effective treatment for atopic dermatitis?
Research shows that MK-6194 targets the immune system, with effects that increase at higher doses. In earlier studies for other conditions, MK-6194 increased the number of regulatory T cells, which control inflammation. This finding is promising for atopic dermatitis, a condition causing long-term skin inflammation. Although data specifically for atopic dermatitis is limited, MK-6194's mechanism suggests potential benefits. Participants in this trial will receive different doses of MK-6194 or a placebo, enabling researchers to evaluate its potential benefits for atopic dermatitis.12678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple rising doses of MK-6194 or placebo every 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MK-6194
Trial Overview
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.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
Participants are randomized to high dose MK-6194 or placebo administered q2w.
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
NCT05450198 | Multiple Rising Dose Study of MK-6194 in ...
The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants with moderate to ...
Multiple Rising Dose Study of MK-6194 in Participants With ...
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...
MK-6194 News
The PK of MK-6194 was linear and dose-proportional, and observed Treg expansion was dose dependent without attenuation after repeat dosing. These results ...
4.
dermatologytimes.com
dermatologytimes.com/view/emerging-therapeutic-for-non-segmental-vitiligo-merck-s-mk-6194Emerging Therapeutic for Non-Segmental Vitiligo: Merck's ...
Iltefat Hamzavi, MD, discusses the REGINA 007 phase 2 trial evaluating MK-6194 for the treatment of non-segmental vitiligo.
A systematic review of interleukin-2-based ...
MK-6194, an IL-2 mutein with preserved CD25 but decreased CD122 binding is tested in two clinical trials in ulcerative colitis and atopic dermatitis, both ...
MK-6194 / Merck (MSD) - Dermatology • Immunology
First-in-human safety, pharmacokinetics, and pharmacodynamics data with MK-6194, a modified form of interleukin-2, designed to selectively activate regulatory ...
7.
ctv.veeva.com
ctv.veeva.com/study/multiple-rising-dose-study-of-mk-6194-in-participants-with-atopic-dermatitis-mk6194008Multiple Rising Dose Study of MK-6194 in Participants With ...
The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants ...
MK-6194 for Atopic Dermatitis · Info for Participants
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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.