Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
- Registration Number
- NCT05450198
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Expansion Panel E Placebo Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w. Expansion Dose F Placebo Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w. Dose Escalation Panel A MK-6194 Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w). Dose Escalation Panel A Placebo Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w). Dose Escalation Panel B MK-6194 Participants are randomized to medium dose MK-6194 or placebo administered q2w. Dose Escalation Panel B Placebo Participants are randomized to medium dose MK-6194 or placebo administered q2w. Dose Escalation Panel C MK-6194 Participants are randomized to high dose MK-6194 or placebo administered q2w. Dose Escalation Panel C Placebo Participants are randomized to high dose MK-6194 or placebo administered q2w. Expansion Panel D MK-6194 Participants are randomized to medium dose MK-6194 or placebo administered q2w. Expansion Panel D Placebo Participants are randomized to medium dose MK-6194 or placebo administered q2w. Expansion Panel E MK-6194 Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w. Expansion Dose F MK-6194 Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience One or More Adverse Events (AEs) Up to approximately 169 days 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.
Number of Participants Who Discontinue Study Intervention Due to an AE Up to approximately 85 days 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.
- Secondary Outcome Measures
Name Time Method 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 Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.
AUC From Days 29-43 (AUC29-43) of MK-6194 Day 29 (Predose and 12 hours postdose), Day 36, and Day 43 Blood samples were collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.
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) Blood samples were collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.
Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29) Predose on Days 15 and 29 Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.
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) Blood samples were collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.
Geometric Mean Accumulation Ratio of AUC of MK-6194 Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43 Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.
Geometric Mean Accumulation Ratio of Cmax of MK-6194 Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43 Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.
Fold Change From Baseline in Peak Regulatory T Cells (Tregs) Baseline and Day 85 Blood samples were collected to determine the fold change from baseline (FCB) in peak Tregs. The peak Treg FCB was evaluated after the last dose of MK-6194 on Day 85 using natural-log transformed values with a linear model containing fixed effects.
Trial Locations
- Locations (19)
AXIS Clinicals ( Site 0029)
🇺🇸Dilworth, Minnesota, United States
Innovaderm Research Inc. ( Site 0019)
🇨🇦Montréal, Quebec, Canada
Progressive Clinical Research ( Site 0022)
🇺🇸San Antonio, Texas, United States
North Texas Center for Clinical Research ( Site 0028)
🇺🇸Frisco, Texas, 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
Premier Clinical Research ( Site 0026)
🇺🇸Spokane, Washington, 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
Remington Davis Clinical Research ( Site 0021)
🇺🇸Columbus, Ohio, United States
Paddington Testing Company ( Site 0010)
🇺🇸Philadelphia, Pennsylvania, United States
Complete Dermatology ( Site 0023)
🇺🇸Sugar Land, Texas, United States
Anima ( Site 0013)
🇧🇪Alken, Limburg, Belgium
Arkansas Research Trials-Clinical Trials ( Site 0002)
🇺🇸North Little Rock, Arkansas, United States
ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00
🇷🇴Bucharest, Bucuresti, Romania
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)
🇷🇴Cluj-Napoca, Cluj, Romania
ARENSIA Exploratory Medicine - Sofia ( Site 0018)
🇧🇬Sofia, Sofia (stolitsa), Bulgaria
Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)
🇪🇸Badalona, Barcelona, Spain