Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
Dermatitis, Atopic
About this trial
This is an interventional treatment trial for Dermatitis, Atopic
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).
Sites / Locations
- Arkansas Research Trials-Clinical Trials ( Site 0002)Recruiting
- Global Health Research Center, Inc. ( Site 0005)Recruiting
- Miami Dermatology and Laser Research ( Site 0025)
- Genesis Clinical Research, LLC ( Site 0004)Recruiting
- ForCare Clinical Research ( Site 0003)Recruiting
- Advanced Medical Research, PC. ( Site 0027)Recruiting
- AXIS Clinicals ( Site 0029)Recruiting
- Remington Davis Clinical Research ( Site 0021)Recruiting
- Paddington Testing Company ( Site 0010)Recruiting
- North Texas Center for Clinical Research ( Site 0028)Recruiting
- Progressive Clinical Research ( Site 0022)Recruiting
- Complete Dermatology ( Site 0023)Recruiting
- Premier Clinical Research ( Site 0026)Recruiting
- Anima ( Site 0013)Recruiting
- ARENSIA Exploratory Medicine - Sofia ( Site 0018)Recruiting
- Innovaderm Research Inc. ( Site 0019)Recruiting
- ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00Recruiting
- ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)Recruiting
- Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Dose Escalation Panel A
Dose Escalation Panel B
Dose Escalation Panel C
Expansion Panel D
Expansion Panel E
Expansion Dose F
Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Participants are randomized to high dose MK-6194 or placebo administered q2w.
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.