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
3 other identifiers
interventional
72
6 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedStudy Start
First participant enrolled
August 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2024
CompletedResults Posted
Study results publicly available
June 5, 2025
CompletedJune 5, 2025
May 1, 2025
1.8 years
July 5, 2022
April 21, 2025
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
Up to approximately 169 days
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study intervention due to an AE is presented.
Up to approximately 85 days
Secondary Outcomes (8)
Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194
Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
AUC From Days 29-43 (AUC29-43) of MK-6194
Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)
Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)
Predose on Days 15 and 29
Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)
Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
- +3 more secondary outcomes
Study Arms (6)
Dose Escalation Panel A
EXPERIMENTALParticipants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).
Dose Escalation Panel B
EXPERIMENTALParticipants are randomized to medium dose MK-6194 or placebo administered q2w.
Dose Escalation Panel C
EXPERIMENTALParticipants are randomized to high dose MK-6194 or placebo administered q2w.
Expansion Panel D
EXPERIMENTALParticipants are randomized to medium dose MK-6194 or placebo administered q2w.
Expansion Panel E
EXPERIMENTALParticipants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.
Expansion Dose F
EXPERIMENTALParticipants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
Interventions
MK-6194 administered subcutaneously (SC)
Placebo comparator to MK-6194 administered SC
Eligibility Criteria
You may not 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Arkansas Research Trials-Clinical Trials ( Site 0002)
North Little Rock, Arkansas, 72117, United States
Miami Dermatology and Laser Research ( Site 0025)
Miami, Florida, 33173, United States
Global Health Research Center, Inc. ( Site 0005)
Miami Lakes, Florida, 33016, United States
Genesis Clinical Research, LLC ( Site 0004)
Tampa, Florida, 33603, United States
ForCare Clinical Research ( Site 0003)
Tampa, Florida, 33613, United States
Advanced Medical Research, PC. ( Site 0027)
Sandy Springs, Georgia, 30328, United States
AXIS Clinicals ( Site 0029)
Dilworth, Minnesota, 56529, United States
Remington Davis Clinical Research ( Site 0021)
Columbus, Ohio, 43215, United States
Paddington Testing Company ( Site 0010)
Philadelphia, Pennsylvania, 19103, United States
North Texas Center for Clinical Research ( Site 0028)
Frisco, Texas, 75034, United States
Progressive Clinical Research ( Site 0022)
San Antonio, Texas, 78213, United States
Complete Dermatology ( Site 0023)
Sugar Land, Texas, 77478, United States
Premier Clinical Research ( Site 0026)
Spokane, Washington, 99202, United States
Anima ( Site 0013)
Alken, Limburg, 3570, Belgium
ARENSIA Exploratory Medicine - Sofia ( Site 0018)
Sofia, Sofia (stolitsa), 1618, Bulgaria
Innovaderm Research Inc. ( Site 0019)
Montreal, Quebec, H2X 2V1, Canada
ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00
Bucharest, București, 11658, Romania
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)
Cluj-Napoca, Cluj, 400006, Romania
Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)
Badalona, Barcelona, 08916, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 8, 2022
Study Start
August 8, 2022
Primary Completion
May 22, 2024
Study Completion
May 22, 2024
Last Updated
June 5, 2025
Results First Posted
June 5, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf