Phase 1
Completed N=72
Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT05450198 ↗
Enrolled (actual)
72
Serious AEs
3.2%
Results posted
Jun 2025
Primary outcomePrimary: Number of Participants Who Experience One or More Adverse Events (AEs) — 13; 6; 30; 9 Participants
Summary
The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants with moderate to severe atopic dermatitis who are unresponsive to other therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience One or More Adverse Events (AEs) |
13; 6; 30; 9; 45 | — |
| PRIMARY Number of Participants Who Discontinue Study Intervention Due to an AE |
0; 1; 2; 0; 3 | — |
| SECONDARY Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194 |
32.3; 59.6 | — |
| SECONDARY AUC From Days 29-43 (AUC29-43) of MK-6194 |
10.9; 56.7; 86.7 | — |
| SECONDARY Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29) |
13.2; 21.7; 20.0 | — |
| SECONDARY Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29) |
0.210 | — |
| SECONDARY Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29) |
0.49; 0.49; 0.49 | — |
| SECONDARY Geometric Mean Accumulation Ratio of AUC of MK-6194 |
0.35; 0.98 | — |
| SECONDARY Geometric Mean Accumulation Ratio of Cmax of MK-6194 |
0.84; 0.98; 1.35 | — |
| SECONDARY Fold Change From Baseline in Peak Regulatory T Cells (Tregs) |
1.15; 1.86; 1.69; 1.58 | — |
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- Clinical diagnosis of atopic dermatitis for at least 6 months prior to the Screening visit.
- Atopic dermatitis is of at least moderate severity.
- History of inadequate response to a stable (≥1 month) regimen of medium to high potency topical corticosteroids or calcineurin inhibitors as treatment for atopic dermatitis within 6 months before the screening visit.
- Body Mass Index (BMI) ≥18 and ≤38 kg/m2 at the screening visit.
Exclusion Criteria
- Concurrent significant skin disease other than atopic dermatitis (such as psoriasis) or a concurrent clinically significant disease.
- Significant organ dysfunction that is unstable or inadequately treated within 6 months prior to Screening.
- History of cancer (malignancy), with the exceptions: of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; other malignancies that have been successfully treated with appropriate follow up.
- History of myocardial infarction, congestive heart failure, uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening.
- History of organ or tissue allograft.
- History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster.
- Major surgery within 3 months prior to the screening visit or has a major surgery planned during the study.
- Received a live or attenuated virus vaccine within 4 weeks prior to the Screening visit or intends to receive live or attenuated virus vaccination during the course of the study and for 12 weeks after the last dose of study drug.
- Currently receiving any chronic systemic (oral or intravenous) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria).
Data sourced from ClinicalTrials.gov (NCT05450198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.