Back to results

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

Primary Purpose

Healthy, Dermatitis, Atopic

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

LY3844583

Placebo

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Parexel Early Phase Unit at Glendale
Medical Corporation Heishinkai OPHAC HospitalRecruiting
P-one clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3844583 (Part A)

LY3844583 (Part B)

LY3844583 (Part C)

Placebo (Part A)

Placebo (Part B)

Placebo (Part C)

Arm Description

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

Multiple doses of LY3844583 administered SC and/or IV.

Repeat doses of LY3844583 administered SC and/or IV.

Placebo administered SC and/or IV.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

PK: Cmax of LY3844583

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

PK: AUC of LY3844583

Full Information

NCT ID

NCT05486208

First Posted

August 2, 2022

Last Updated

October 10, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05486208

Brief Title

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

Official Title

A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3844583 in Healthy Participants, and Multiple-Dose Study of LY3844583 in Healthy Participants and Patients With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 11, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Dermatitis, Atopic

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LY3844583 (Part A)

Arm Type

Experimental

Arm Description

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

Arm Title

LY3844583 (Part B)

Arm Type

Experimental

Arm Description

Multiple doses of LY3844583 administered SC and/or IV.

Arm Title

LY3844583 (Part C)

Arm Type

Experimental

Arm Description

Repeat doses of LY3844583 administered SC and/or IV.

Arm Title

Placebo (Part A)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC and/or IV.

Arm Title

Placebo (Part B)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC and/or IV.

Arm Title

Placebo (Part C)

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC and/or IV.

Intervention Type

Drug

Intervention Name(s)

LY3844583

Intervention Description

Administered SC and/or IV.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC and/or IV.

Primary Outcome Measure Information:

Title

Description

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

Time Frame

Baseline up to Day 186

Secondary Outcome Measure Information:

Title

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

Description

PK: Cmax of LY3844583

Time Frame

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

Title

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

Description

PK: AUC of LY3844583

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone

1-317-615-4559

ClinicalTrials.gov@Lilly.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Parexel Early Phase Unit at Glendale

City

Glendale

State/Province

California

ZIP/Postal Code

91206-4140

Country

United States

Individual Site Status

Completed

Facility Name

Medical Corporation Heishinkai OPHAC Hospital

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

532-0003

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

Phone

81663959000

First Name & Middle Initial & Last Name & Degree

Michio Yagi

Facility Name

P-one clinic

City

Hachioji

State/Province

Tokyo

ZIP/Postal Code

192-0071

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

Phone

81426255216

First Name & Middle Initial & Last Name & Degree

Kenichi Furihata

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs