Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
NCT ID: NCT05450198
Last Updated: 2025-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2022-08-08
2024-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Dose Escalation Panel A
Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Dose Escalation Panel B
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Dose Escalation Panel C
Participants are randomized to high dose MK-6194 or placebo administered q2w.
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Expansion Panel D
Participants are randomized to medium dose MK-6194 or placebo administered q2w.
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Expansion Panel E
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Expansion Dose F
Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Interventions
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MK-6194
MK-6194 administered subcutaneously (SC)
Placebo
Placebo comparator to MK-6194 administered SC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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, București, 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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-6194-008
Identifier Type: OTHER
Identifier Source: secondary_id
2022-001011-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6194-008
Identifier Type: -
Identifier Source: org_study_id
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