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

June 3, 2025 updated by: Merck Sharp & Dohme LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: 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.
Up to approximately 169 days
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: 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.
Up to approximately 85 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194
Time Frame: 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.
Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
AUC From Days 29-43 (AUC29-43) of MK-6194
Time Frame: 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.
Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)
Time Frame: 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.
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)
Time Frame: Predose on Days 15 and 29
Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.
Predose on Days 15 and 29
Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)
Time Frame: 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.
Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
Geometric Mean Accumulation Ratio of AUC of MK-6194
Time Frame: 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.
Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Geometric Mean Accumulation Ratio of Cmax of MK-6194
Time Frame: 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.
Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Fold Change From Baseline in Peak Regulatory T Cells (Tregs)
Time Frame: 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.
Baseline and Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6194-008
  • MK-6194-008 (Other Identifier: MSD)
  • 2022-001011-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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