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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Biological: MK-6194; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Alken, Limburg, Belgium, 3570
      • Anima ( Site 0013)
• Bulgaria
  • Sofia (stolitsa)
    • Sofia, Sofia (stolitsa), Bulgaria, 1618
      • ARENSIA Exploratory Medicine - Sofia ( Site 0018)
• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc. ( Site 0019)
• Romania
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 11658
      • ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)
• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)
• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials-Clinical Trials ( Site 0002)
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Research ( Site 0025)
    • Miami Lakes, Florida, United States, 33016
      • Global Health Research Center, Inc. ( Site 0005)
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC ( Site 0004)
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research ( Site 0003)
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research, PC. ( Site 0027)
  • Minnesota
    • Dilworth, Minnesota, United States, 56529
      • AXIS Clinicals ( Site 0029)
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington Davis Clinical Research ( Site 0021)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company ( Site 0010)
  • Texas
    • Frisco, Texas, United States, 75034
      • North Texas Center for Clinical Research ( Site 0028)
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research ( Site 0022)
    • Sugar Land, Texas, United States, 77478
      • Complete Dermatology ( Site 0023)
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research ( Site 0026)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Panel A; Participants are randomized to low dose MK-6194 or placebo, administered every 2 weeks (q2w).	Biological: MK-6194; MK-6194 administered subcutaneously (SC); Biological: Placebo; Placebo comparator to MK-6194 administered SC
Experimental: Dose Escalation Panel B; Participants are randomized to medium dose MK-6194 or placebo administered q2w.	Biological: MK-6194; MK-6194 administered subcutaneously (SC); Biological: Placebo; Placebo comparator to MK-6194 administered SC
Experimental: Dose Escalation Panel C; Participants are randomized to high dose MK-6194 or placebo administered q2w.	Biological: MK-6194; MK-6194 administered subcutaneously (SC); Biological: Placebo; Placebo comparator to MK-6194 administered SC
Experimental: Expansion Panel D; Participants are randomized to medium dose MK-6194 or placebo administered q2w.	Biological: MK-6194; MK-6194 administered subcutaneously (SC); Biological: Placebo; Placebo comparator to MK-6194 administered SC
Experimental: Expansion Panel E; Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo administered q2w.	Biological: MK-6194; MK-6194 administered subcutaneously (SC); Biological: Placebo; Placebo comparator to MK-6194 administered SC
Experimental: Expansion Dose F; Participants are randomized to a dose less than or equal to high dose MK-6194 or placebo q2w.	Biological: MK-6194; MK-6194 administered subcutaneously (SC); Biological: Placebo; Placebo comparator to MK-6194 administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: 6194-008; MK-6194-008 (Other Identifier: Merck); 2022-001011-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No