NCT05450198CompletedPhase 1
Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-6194 in Participants With Moderate to Severe Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 5 Jul 2022
- Start date
- 8 Aug 2022
- Primary completion date
- 22 May 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05450198
- EudraCT number
- 2022-001011-12
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 72
- From 8 Aug 2022 to the primary completion date, 22 May 2024
- 19 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
Other illness
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- The main inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anima ( Site 0013) Coordinator of this site? Confirm its status | Alken | Belgium | Unknown status |
| ARENSIA Exploratory Medicine - Sofia ( Site 0018) Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Innovaderm Research Inc. ( Site 0019) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012) Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00 Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017) Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Remington Davis Clinical Research ( Site 0021) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| AXIS Clinicals ( Site 0029) Coordinator of this site? Confirm its status | Dilworth | United States | Unknown status |
| North Texas Center for Clinical Research ( Site 0028) Coordinator of this site? Confirm its status | Frisco | United States | Unknown status |
| Miami Dermatology and Laser Research ( Site 0025) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Global Health Research Center, Inc. ( Site 0005) Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Arkansas Research Trials-Clinical Trials ( Site 0002) Coordinator of this site? Confirm its status | North Little Rock | United States | Unknown status |
| Paddington Testing Company ( Site 0010) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Progressive Clinical Research ( Site 0022) Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Advanced Medical Research, PC. ( Site 0027) Coordinator of this site? Confirm its status | Sandy Springs | United States | Unknown status |
| Premier Clinical Research ( Site 0026) Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Complete Dermatology ( Site 0023) Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Genesis Clinical Research, LLC ( Site 0004) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| ForCare Clinical Research ( Site 0003) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.