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Completed

NCT Number: NCT05450198

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anima ( Site 0013), Alken, Limburg, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MK-6194

Biological

MK-6194 administered subcutaneously (SC)

Placebo

Biological

Placebo comparator to MK-6194 administered SC

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2022
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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