Multiple Rising Dose Study of MK-6194 in Participants With Atopic Dermatitis (MK-6194-008)

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05450198
• Other study ID #: 6194-008
• Secondary ID: MK-6194-0082022-
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2022
• Est. completion date: May 22, 2024

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 22, 2024
• Est. primary completion date: May 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Biological:
• MK-6194
MK-6194 administered subcutaneously (SC)
• Placebo
Placebo comparator to MK-6194 administered SC

Locations

Country	Name	City	State
Belgium	Anima ( Site 0013)	Alken	Limburg
Bulgaria	ARENSIA Exploratory Medicine - Sofia ( Site 0018)	Sofia	Sofia (stolitsa)
Canada	Innovaderm Research Inc. ( Site 0019)	Montréal	Quebec
Romania	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
Spain	Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)	Badalona	Barcelona
United States	Remington Davis Clinical Research ( Site 0021)	Columbus	Ohio
United States	AXIS Clinicals ( Site 0029)	Dilworth	Minnesota
United States	North Texas Center for Clinical Research ( Site 0028)	Frisco	Texas
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	Arkansas Research Trials-Clinical Trials ( Site 0002)	North Little Rock	Arkansas
United States	Paddington Testing Company ( Site 0010)	Philadelphia	Pennsylvania
United States	Progressive Clinical Research ( Site 0022)	San Antonio	Texas
United States	Advanced Medical Research, PC. ( Site 0027)	Sandy Springs	Georgia
United States	Premier Clinical Research ( Site 0026)	Spokane	Washington
United States	Complete Dermatology ( Site 0023)	Sugar Land	Texas
United States	ForCare Clinical Research ( Site 0003)	Tampa	Florida
United States	Genesis Clinical Research, LLC ( Site 0004)	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 169 days
Primary	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.	Up to approximately 85 days
Secondary	Area Under the Curve (AUC) from Days 1-15 (AUC1-15) of MK-6194	Blood samples will be collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.	At protocol specific time points from Day 1 to Day 15
Secondary	AUC from Days 29-43 (AUC29-43) of MK-6194	Blood samples will be collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.	At protocol specific time points from Day 29 to Day 43
Secondary	Peak Serum Concentration (Cmax) of MK-6194	Blood samples will be collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.	At protocol specific time points from Day 1 to Day 29
Secondary	Minimum Serum Concentration (Ctrough) of MK-6194	Blood samples will be collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.	Days 15, 29, 43, and 85: Predose
Secondary	Time to peak Serum Concentration (Tmax) of MK-6194	Blood samples will be collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.	At protocol specific time points from Day 1 to Day 29
Secondary	Geometric Mean Accumulation Ratio of AUC of MK-6194	Blood samples will be collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194.	At protocol specific time points from Day 1 to Day 15 and Day 29 to Day 43
Secondary	Geometric Mean Accumulation Ratio of Cmax of MK-6194	Blood samples will be collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194.	At protocol specific time points from Day 1 to Day 15 and Day 29 to Day 43
Secondary	Fold Change from Baseline in Peak Regulatory T cells (Tregs)	Blood samples will be collected at baseline and at pre-specified timepoints up to day 169 to determine the fold change from baseline in peak Tregs.	Baseline and up to approximately 169 days

External Links

•   Merck Clinical Trials Information