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

NCT06119529 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 18607J4L-MC-KMAA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy; Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• Part A: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and Other Non-serious Adverse Events (AEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.

  Baseline through Day 85

• Part B: Number of Participants With One or More TEAEs, SAEs and Other Non-serious AEs Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.

  Baseline through Day 183

• Part C: Number of Participants With One or More TEAEs, SAEs and Other Non-serious AEs Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.

  Baseline through Day 44

Secondary Outcomes (4)

• Pharmacokinetics (PK): Part A and B: Maximum Observed Concentration (Cmax) of LY3872386

  Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A)

• PK: Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386

  Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A)

• PK: Part C: Cmax of Prednisone and Prednisolone

  Predose up to 12 hours post dose on day 14 and day 30

• PK: Part C: AUC of Prednisone and Prednisolone

  Predose up to 12 hours post dose on day 14 and day 30

Study Arms (4)

Part A: LY3872386

EXPERIMENTAL

Single doses of LY3872386 (low dose, mid dose, and high dose) administered intravenously (IV) in healthy participants.

Drug: LY3872386

Part B: LY3872386

EXPERIMENTAL

Part B was planned but not initiated as study terminated early due to emerging nonclinical data.

Drug: LY3872386

Part C: Prednisone

EXPERIMENTAL

Part C was planned but not initiated as study terminated early due to emerging nonclinical data.

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Placebo administered IV in healthy participants.

Drug: Placebo

Interventions

LY3872386 DRUG

Administered IV.

Part A: LY3872386; Part B: LY3872386

Prednisone DRUG

Administered orally.

Part C: Prednisone

Placebo DRUG

Administered IV.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A and C:
• Overtly healthy as determined by medical evaluation
• To qualify as Japanese for the purpose of this study, the participant must be first generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan
• 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's biological 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 of contraception and women not of childbearing potential may participate in part A and C
• Part B:
• Participants who have a diagnosis of atopic dermatitis at least 12 months prior to screening as defined by the American Academy of Dermatology
• Have a history, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or participants who failed systemic therapies intended to treat atopic dermatitis or a history 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 of contraception, women not of childbearing potential and women of childbearing potential may participate in part B

You may not qualify if:

• 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 anaphylactic reaction to prescription or nonprescription drugs
• Have a known history of diabetes
• Have fasting glucose level of ≥126 milligrams per deciliter (mg/dL) and glycated hemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening
• Have known history of osteoporosis

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

CenExel ACT

Anaheim, California, 92801, United States

Location

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Based on the emerging nonclinical data, Study KMAA was terminated after the dosing of participants in SAD Cohorts 1 and 2 (Dose 1 IV and Dose 2 IV) and the sentinel pair in SAD Cohort 3 (Dose 3 IV).

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part A, B are double blind and part C is open-label.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: October 3, 2025
• Results First Posted: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)