A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis

NCT05486208 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 18365J3V-MC-KKAA
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 3

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis. The study will also assess how fast LY3844583 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants and participants with atopic dermatitis. The study will be conducted in three parts and each participant will enroll in one part. The study will last up to 88, 116, and 186 days with 10, 13, and 14 visits for each participant in parts A, B, and C, respectively.

Conditions

Healthy; Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of AEs, TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to Day 186

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3844583

  Pre-dose on Day 1 up to 186 days post-dose

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3844583

  Pre-dose on Day 1 up to 186 days post-dose

Study Arms (6)

LY3844583 (Part A)

EXPERIMENTAL

Single doses of LY3844583 administered subcutaneously (SC) and/or intravenously (IV).

Drug: LY3844583

LY3844583 (Part B)

EXPERIMENTAL

Multiple doses of LY3844583 administered SC and/or IV.

Drug: LY3844583

LY3844583 (Part C)

EXPERIMENTAL

Repeat doses of LY3844583 administered SC and/or IV.

Drug: LY3844583

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC and/or IV.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC and/or IV.

Drug: Placebo

Placebo (Part C)

PLACEBO COMPARATOR

Placebo administered SC and/or IV.

Drug: Placebo

Interventions

LY3844583 DRUG

Administered SC and/or IV.

LY3844583 (Part A); LY3844583 (Part B); LY3844583 (Part C)

Placebo DRUG

Administered SC and/or IV.

Placebo (Part A); Placebo (Part B); Placebo (Part C)

Eligibility Criteria

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

You may qualify if:

• Healthy participants (Parts A and B):
• Are male or female not of childbearing potential
• Must have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive. For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m², inclusive, and a body weight of 50 kg to 85 kg, inclusive.
• Atopic dermatitis participants (Part C):
• Must have a body mass index of 18.0 to 45.0 kg/m², inclusive
• Are male or female participants including those of child bearing potential
• Must have a diagnosis of AD for at least 12 months with either poor response to topical treatments or inability to use topical treatments
• Must agree to use moisturizer daily throughout the treatment period

You may not qualify if:

• All participants:
• Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Have active or latent tuberculosis
• Have had any cancer within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma, with no evidence of recurrence or metastatic disease within the 3 years prior to baseline
• Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
• Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 30 days or 5 half-lives (whichever is longer) prior to dosing
• Must not have previously completed a clinical trial with a molecule targeting interleukin-33 and/or the interleukin-33 receptor (ST2)
• Are currently participating in or completed a clinical trial within the last 30 days
• Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study
• Atopic dermatitis participants:
• Must not have received certain topical medications for AD within 2 weeks prior to randomization
• Must not have received certain oral medications for AD or received phototherapy within 4 weeks prior to randomization
• Must not have received any antibody-based biologic agents (marketed or investigational) within 5 half lives (t1/2) of the drug prior to randomization
• Must not have received intravenous, intramuscular, or intra-articular steroids in the past 6 weeks prior to randomization

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Parexel Early Phase Unit at Glendale

Glendale, California, 91206-4140, United States

Location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

P-one clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

Related Links

• A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis

MeSH Terms

Conditions

Dermatitis, Atopic

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

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 3, 2022
• Study Start: August 11, 2022
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); US (1)