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

  • STATUS
    Recruiting
  • End date
    Jan 12, 2024
  • participants needed
    72
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 21 October 2022
body mass index
corticosteroids
topical corticosteroid
topical agents
high potency

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.

Details
Condition Dermatitis, Atopic
Treatment Placebo, MK-6194
Clinical Study IdentifierNCT05450198
SponsorMerck Sharp & Dohme LLC
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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)
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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