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

Phase 1

Terminated

• Conditions: Atopic Dermatitis; Healthy
• Interventions: Drug: LY3872386; Drug: Prednisone; Drug: Placebo

• Registration Number: NCT06119529
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Primary Completion: 2024-04-08
• Study Completion: 2024-04-08
• Results First Submitted: 2025-08-14
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Results First Posted: 2025-10-03
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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 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
  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'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

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: LY3872386	LY3872386	Single doses of LY3872386 (low dose, mid dose, and high dose) administered intravenously (IV) in healthy participants.
Part B: LY3872386	LY3872386	Part B was planned but not initiated as study terminated early due to emerging nonclinical data.
Part C: Prednisone	Prednisone	Part C was planned but not initiated as study terminated early due to emerging nonclinical data.
Placebo	Placebo	Placebo administered IV in healthy participants.

Primary Outcome Measures

Name	Time	Method
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	Baseline through Day 85	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.
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	Baseline through Day 183	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.
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	Baseline through Day 44	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.

Secondary Outcome Measures

Name	Time	Method
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)	Cmax of LY3872386 is reported.
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)	Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC\[0-tlast\]) and Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\]) of LY3872386 is reported.
PK: Part C: Cmax of Prednisone and Prednisolone	Predose up to 12 hours post dose on day 14 and day 30	Zero participants were analyzed in this outcome as study was terminated early.
PK: Part C: AUC of Prednisone and Prednisolone	Predose up to 12 hours post dose on day 14 and day 30	Zero participants were analyzed in this outcome as study was terminated early.

Trial Locations

Locations (2)

CenExel ACT; 🇺🇸 Anaheim, California, United States

Fortrea Clinical Research Unit; 🇺🇸 Daytona Beach, Florida, United States