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

Healthy Clinical Trial

Official title:

A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evaluation of the Safety and Tolerability of Prednisone in Healthy Participants.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119529
• Other study ID #: 18607
• Secondary ID: J4L-MC-KMAA
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 179
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Healthy

Intervention

Drug:
• LY3872386
Administered either IV or SC.
• Prednisone
Administered orally.
• Placebo
Administered either IV or SC.

Locations

Country	Name	City	State
Japan	P-one Clinic	Hachioji	Tokyo
Japan	Medical Corporation Heishinkai OPHAC Hospital	Osaka-shi	Osaka
United States	CenExel ACT	Anaheim	California
United States	Fortrea Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 85
Primary	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 TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 183
Primary	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 TEAEs, SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 44
Secondary	Part A and B: Maximum Observed Concentration (Cmax) of LY3872386	Pharmacokinetic (PK) parameter is determined after administration of LY3872386	Predose up to 85 days (Part A) and 183 days (Part B)
Secondary	Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386	PK parameter is determined after administration of LY3872386	Predose up to 85 days (Part A) and 183 days (Part B)
Secondary	Part C: Cmax of Prednisone and Prednisolone		Predose up to 12 hours post dose on day 14 and day 30
Secondary	Part C: AUC of Prednisone and Prednisolone		Predose up to 12 hours post dose on day 14 and day 30