A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis

Last updated: July 24, 2024
Sponsor: Eli Lilly and Company
Overall Status: Terminated

Phase

1

Condition

Hives (Urticaria)

Skin Infections/disorders

Eczema (Atopic Dermatitis)

Treatment

Placebo

Prednisone

LY3872386

Clinical Study ID

NCT06119529
18607
J4L-MC-KMAA
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3872386 in healthy participants and participants with atopic dermatitis. The safety of prednisone is also evaluated in healthy participants. Blood tests will be performed to investigate how the body processes the LY3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. Blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. The study is conducted in three parts (part A, B and C). The study will last up to approximately 85, 183 and 44 days for parts A, B, and C, respectively.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Part A and C:

  • Overtly healthy as determined by medical evaluation
  1. To qualify as Japanese for the purpose of this study, the participant must befirst generation Japanese, defined as the participant's biological parents andall of the participant's biological grandparents must be of exclusive Japanesedescent, and must have been born in Japan

  2. To qualify as Chinese for the purpose of this study, the participant must be,at a minimum, third-generation Chinese, defined as all 4 of the participant'sbiological grandparents must be of exclusive Chinese descent and born in China

  • Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

  • Male participants who agree to use highly effective or effective methods ofcontraception and women not of childbearing potential may participate in part A andC

Part B:

  • Participants who have a diagnosis of atopic dermatitis at least 12 months prior toscreening as defined by the American Academy of Dermatology

  • Have a history, documented by a physician and/or investigator, of inadequateresponse to existing topical medications within 6 months preceding screening, orparticipants who failed systemic therapies intended to treat atopic dermatitis or ahistory of intolerance to topical therapy

  • Have a body mass index of 18.0 to 38.0 kilograms per square meter (kg/m²), inclusive

  • Male participants who agree to use highly effective or effective methods ofcontraception, women not of childbearing potential and women of childbearingpotential may participate in part B

Exclusion

Exclusion Criteria:

  • Women who are pregnant and/or lactating

  • Participants who have received live vaccine(s) (including attenuated live vaccines)or Bacillus Calmette- Guérin within 35 days of screening

  • Have a history or presence of multiple or severe allergies or an anaphylacticreaction to prescription or nonprescription drugs

  • Have a known history of diabetes

  • Have fasting glucose level of ≥126 milligrams per deciliter (mg/dL) and glycatedhemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening

  • Have known history of osteoporosis

Study Design

Total Participants: 18
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 01, 2023
Estimated Completion Date:
April 08, 2024

Connect with a study center

  • Anima Research Center

    Alken, Hesbaye 3570
    Belgium

    Site Not Available

  • CRU Hungary Ltd. - Early Phase Unit

    Kistarcsa, Pest H-2143
    Hungary

    Site Not Available

  • Budai Irgalmasrendi Korhaz

    Budapest, H-1027
    Hungary

    Site Not Available

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka-shi, Osaka 532-0003
    Japan

    Site Not Available

  • P-one Clinic

    Hachioji, Tokyo 192-0071
    Japan

    Site Not Available

  • Medicines Evaluation Unit Ltd.

    Manchester, England M23 9QZ
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, England M23 9QZ
    United Kingdom

    Site Not Available

  • Liverpool University Hospital Foundation Trust, Clinical Research Facility

    Liverpool, Merseyside L7 8XP
    United Kingdom

    Site Not Available

  • BDD Pharma Ltd

    Glasgow, Scotland G4 0SF
    United Kingdom

    Site Not Available

  • Glasgow Royal Infirmary

    Glasgow, Scotland G4 0SF
    United Kingdom

    Site Not Available

  • CenExel ACT

    Anaheim, California 92801
    United States

    Site Not Available

  • Fortrea Clinical Research Unit

    Daytona Beach, Florida 32117
    United States

    Site Not Available

  • Miami Clinical Reserach

    Miami, Florida 33155
    United States

    Site Not Available

  • Skin Sciences, PLLC

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Paddington Testing Co, Inc

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

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