MK-6194 for Atopic Dermatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Atopic DermatitisMK-6194 - Biological
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Days 15, 29, 43, and 85: Predose

Day 15
Area Under the Curve (AUC) from Days 1-15 (AUC1-15) of MK-6194
Day 43
Geometric Mean Accumulation Ratio of AUC of MK-6194
Geometric Mean Accumulation Ratio of Cmax of MK-6194
Day 29
Peak Serum Concentration (Cmax) of MK-6194
Time to peak Serum Concentration (Tmax) of MK-6194
Day 43
AUC from Days 29-43 (AUC29-43) of MK-6194
Day 169
Fold Change from Baseline in Peak Regulatory T cells (Tregs)
Day 15
Minimum Serum Concentration (Ctrough) of MK-6194
Day 169
Number of Participants who Experience One or More Adverse Events (AEs)
Day 85
Number of Participants who Discontinue Study Intervention Due to an AE

Trial Safety

Trial Design

6 Treatment Groups

Dose Escalation Panel B
1 of 6
Expansion Panel E
1 of 6
Expansion Panel D
1 of 6
Dose Escalation Panel C
1 of 6
Dose Escalation Panel A
1 of 6
Expansion Dose F
1 of 6

Experimental Treatment

72 Total Participants · 6 Treatment Groups

Primary Treatment: MK-6194 · Has Placebo Group · Phase 1

Dose Escalation Panel BExperimental Group · 2 Interventions: MK-6194, Placebo · Intervention Types: Biological, Biological
Expansion Panel EExperimental Group · 2 Interventions: MK-6194, Placebo · Intervention Types: Biological, Biological
Expansion Panel DExperimental Group · 2 Interventions: MK-6194, Placebo · Intervention Types: Biological, Biological
Dose Escalation Panel CExperimental Group · 2 Interventions: MK-6194, Placebo · Intervention Types: Biological, Biological
Dose Escalation Panel AExperimental Group · 2 Interventions: MK-6194, Placebo · Intervention Types: Biological, Biological
Expansion Dose FExperimental Group · 2 Interventions: MK-6194, Placebo · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 15, 29, 43, and 85: predose

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,683 Previous Clinical Trials
4,958,036 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,639 Previous Clinical Trials
7,942,266 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

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