MK-6194 for Atopic Dermatitis

No longer recruiting at 20 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Chronic systemic anti-infectives

Disqualifiers: Psoriasis, Cancer, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

My skin condition is moderate to severe.

My skin condition didn't improve after using strong skin creams for over a month.

Your body mass index (BMI) should be between 18 and 38.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple rising doses of MK-6194 or placebo every 2 weeks

12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person)

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?

Group I: Expansion Panel E Experimental Treatment 2 Interventions

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

Group II: Expansion Panel D Experimental Treatment 2 Interventions

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

Group III: Expansion Dose F Experimental Treatment 2 Interventions

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

Group IV: Dose Escalation Panel C Experimental Treatment 2 Interventions

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

Group V: Dose Escalation Panel B Experimental Treatment 2 Interventions

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

Group VI: Dose Escalation Panel A Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05450198

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05450198?tab=results

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 ...

3. sigma.larvol.com sigma.larvol.com/product.php?e1=839035&tab=newstrac

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-6194

Emerging 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10111960/

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 ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=594a97e6-b078-456f-9204-a4a0da5ab5b5

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-mk6194008

Multiple 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 ...

8. withpower.com withpower.com/trial/phase-1-dermatitis-atopic-7-2022-ce706

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 ...