Clinical trial NCT05450198: Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 169 days
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 85 days
Secondary outcomes:
measure: Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194
timeFrame: Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
measure: AUC From Days 29-43 (AUC29-43) of MK-6194
timeFrame: Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
measure: Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)
timeFrame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
measure: Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)
timeFrame: Predose on Days 15 and 29
measure: Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)
timeFrame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
measure: Geometric Mean Accumulation Ratio of AUC of MK-6194
timeFrame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
measure: Geometric Mean Accumulation Ratio of Cmax of MK-6194
timeFrame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
measure: Fold Change From Baseline in Peak Regulatory T Cells (Tregs)
timeFrame: Baseline and Day 85
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Arkansas Research Trials-Clinical Trials ( Site 0002)
state: Arkansas
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc. ( Site 0005)
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research ( Site 0025)
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0004)
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research ( Site 0003)
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC. ( Site 0027)
state: Georgia
city: Dilworth
country: United States
facility: AXIS Clinicals ( Site 0029)
state: Minnesota
city: Columbus
country: United States
facility: Remington Davis Clinical Research ( Site 0021)
state: Ohio
city: Philadelphia
country: United States
facility: Paddington Testing Company ( Site 0010)
state: Pennsylvania
city: Frisco
country: United States
facility: North Texas Center for Clinical Research ( Site 0028)
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research ( Site 0022)
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology ( Site 0023)
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research ( Site 0026)
state: Washington
city: Alken
country: Belgium
facility: Anima ( Site 0013)
state: Limburg
city: Sofia
country: Bulgaria
facility: ARENSIA Exploratory Medicine - Sofia ( Site 0018)
state: Sofia (stolitsa)
city: Montréal
country: Canada
facility: Innovaderm Research Inc. ( Site 0019)
state: Quebec
city: Bucharest
country: Romania
facility: ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)
state: Cluj
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)
state: Barcelona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: