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

NCT ID: NCT05486208

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2024-01-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3844583 (Part A)

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

Group Type: EXPERIMENTAL

LY3844583

Intervention Type: DRUG

Administered SC and/or IV.

LY3844583 (Part B)

Multiple doses of LY3844583 administered SC and/or IV.

Group Type: EXPERIMENTAL

LY3844583

Intervention Type: DRUG

Administered SC and/or IV.

LY3844583 (Part C)

Repeat doses of LY3844583 administered SC and/or IV.

Group Type: EXPERIMENTAL

LY3844583

Intervention Type: DRUG

Administered SC and/or IV.

Placebo (Part A)

Placebo administered SC and/or IV.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC and/or IV.

Placebo (Part B)

Placebo administered SC and/or IV.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC and/or IV.

Placebo (Part C)

Placebo administered SC and/or IV.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC and/or IV.

Interventions

LY3844583

Administered SC and/or IV.

Intervention Type: DRUG

Placebo

Administered SC and/or IV.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy participants (Parts A and B):

• Are male or female not of childbearing potential
• inclusion of healthy Japanese participants, 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.
• inclusion of healthy Chinse participants, the participant must be at a minimum, third-generation Chinese, defined as all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China.
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Parexel Early Phase Unit at Glendale

Glendale, California, United States

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, Japan

P-one clinic

Hachiōji, Tokyo, Japan

Countries

United States; Japan

Related Links

https://trials.lilly.com/en-US/trial/352936

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

Other Identifiers

J3V-MC-KKAA

Identifier Type: OTHER

Identifier Source: secondary_id

18365

Identifier Type: -

Identifier Source: org_study_id