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

Last updated: May 31, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

1

Condition

Dermatitis, Atopic

Eczema (Atopic Dermatitis - Pediatric)

Rash

Treatment

MK-6194

Placebo

Clinical Study ID

NCT05450198
6194-008
MK-6194-008
2022-001011-12
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Screeningvisit.

  • Atopic dermatitis is of at least moderate severity.

  • History of inadequate response to a stable (≥1 month) regimen of medium to highpotency topical corticosteroids or calcineurin inhibitors as treatment for atopicdermatitis within 6 months before the screening visit.

  • Body Mass Index (BMI) ≥18 and ≤38 kg/m2 at the screening visit.

Exclusion

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 6months prior to Screening.

  • History of cancer (malignancy), with the exceptions: of adequately treatednonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; othermalignancies that have been successfully treated with appropriate follow up.

  • History of myocardial infarction, congestive heart failure, uncontrolledarrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, oruncontrolled diabetes within 6 months of Screening.

  • History of organ or tissue allograft.

  • History of symptomatic herpes zoster within 16 weeks of randomization, or anyhistory of disseminated herpes simplex, disseminated herpes zoster, ophthalmiczoster, or central nervous system (CNS) zoster.

  • Major surgery within 3 months prior to the screening visit or has a major surgeryplanned during the study.

  • Received a live or attenuated virus vaccine within 4 weeks prior to the Screeningvisit or intends to receive live or attenuated virus vaccination during the courseof the study and for 12 weeks after the last dose of study drug.

  • Currently receiving any chronic systemic (oral or intravenous) anti-infectivetherapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster,or atypical mycobacteria).

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: MK-6194
Phase: 1
Study Start date:
August 08, 2022
Estimated Completion Date:
May 22, 2024

Connect with a study center

  • Anima ( Site 0013)

    Alken, Limburg 3570
    Belgium

    Site Not Available

  • ARENSIA Exploratory Medicine - Sofia ( Site 0018)

    Sofia, Sofia (stolitsa) 1618
    Bulgaria

    Site Not Available

  • Innovaderm Research Inc. ( Site 0019)

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • ARENSIA Exploratory Medicine-SC ARENSIA Exploratory Medicine SRL with Monza Medical Center ( Site 00

    Bucharest, Bucuresti 11658
    Romania

    Site Not Available

  • ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0011)

    București, Bucuresti 010701
    Romania

    Site Not Available

  • ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0017)

    Cluj-Napoca, Cluj 400006
    Romania

    Site Not Available

  • Hospital Germans Trias i Pujol-CCEE Dermatologia ( Site 0012)

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Arkansas Research Trials-Clinical Trials ( Site 0002)

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Miami Dermatology and Laser Research ( Site 0025)

    Miami, Florida 33173
    United States

    Site Not Available

  • Global Health Research Center, Inc. ( Site 0005)

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • ForCare Clinical Research ( Site 0003)

    Tampa, Florida 33613
    United States

    Site Not Available

  • Genesis Clinical Research, LLC ( Site 0004)

    Tampa, Florida 33603
    United States

    Site Not Available

  • Advanced Medical Research, PC. ( Site 0027)

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • AXIS Clinicals ( Site 0029)

    Dilworth, Minnesota 56529
    United States

    Site Not Available

  • Remington Davis Clinical Research ( Site 0021)

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Paddington Testing Company ( Site 0010)

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • North Texas Center for Clinical Research ( Site 0028)

    Frisco, Texas 75034
    United States

    Site Not Available

  • Progressive Clinical Research ( Site 0022)

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Complete Dermatology ( Site 0023)

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Premier Clinical Research ( Site 0026)

    Spokane, Washington 99202
    United States

    Site Not Available

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