Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
Completed · Phase 1 · Has a placebo group
Conditions studied: Dermatitis, Atopic
In brief
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.
Key facts
- Study ID
- NCT05450198
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 72
- Starts
- 2022-08-08
- Expected to finish
- 2024-05-22
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Arkansas Research Trials-Clinical Trials ( Site 0002) — North Little Rock, Arkansas, United States
- Miami Dermatology and Laser Research ( Site 0025) — Miami, Florida, United States
- Global Health Research Center, Inc. ( Site 0005) — Miami Lakes, Florida, United States
- Genesis Clinical Research, LLC ( Site 0004) — Tampa, Florida, United States
- ForCare Clinical Research ( Site 0003) — Tampa, Florida, United States
- Advanced Medical Research, PC. ( Site 0027) — Sandy Springs, Georgia, United States
- AXIS Clinicals ( Site 0029) — Dilworth, Minnesota, United States
- Remington Davis Clinical Research ( Site 0021) — Columbus, Ohio, United States
- Paddington Testing Company ( Site 0010) — Philadelphia, Pennsylvania, United States
- North Texas Center for Clinical Research ( Site 0028) — Frisco, Texas, United States
- Progressive Clinical Research ( Site 0022) — San Antonio, Texas, United States
- Complete Dermatology ( Site 0023) — Sugar Land, Texas, United States
- Premier Clinical Research ( Site 0026) — Spokane, Washington, United States
- Anima ( Site 0013) — Alken, Limburg, Belgium
- ARENSIA Exploratory Medicine - Sofia ( Site 0018) — Sofia, Sofia (stolitsa), Bulgaria
- Innovaderm Research Inc. ( Site 0019) — Montreal, Quebec, Canada
- ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00 — Bucharest, Bucharest, Romania
- ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017) — Cluj-Napoca, Cluj, Romania
- Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012) — Badalona, Barcelona, Spain
Full record on ClinicalTrials.gov
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