MK-6194 for Atopic Dermatitis

Recruiting at 19 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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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