- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05486208
A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis
January 24, 2024 updated by: Eli Lilly and Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: ClinicalTrials.gov@lilly.com
Study Locations
-
-
Osaka
-
Osaka-shi, Osaka, Japan, 532-0003
- Medical Corporation Heishinkai OPHAC Hospital
-
-
Tokyo
-
Hachioji, Tokyo, Japan, 192-0071
- P-One Clinic
-
-
-
-
California
-
Glendale, California, United States, 91206-4140
- Parexel Early Phase Unit at Glendale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY3844583 (Part A)
Single doses of LY3844583 administered subcutaneously (SC) and/or intravenously (IV).
|
Administered SC and/or IV.
|
Experimental: LY3844583 (Part B)
Multiple doses of LY3844583 administered SC and/or IV.
|
Administered SC and/or IV.
|
Experimental: LY3844583 (Part C)
Repeat doses of LY3844583 administered SC and/or IV.
|
Administered SC and/or IV.
|
Placebo Comparator: Placebo (Part A)
Placebo administered SC and/or IV.
|
Administered SC and/or IV.
|
Placebo Comparator: Placebo (Part B)
Placebo administered SC and/or IV.
|
Administered SC and/or IV.
|
Placebo Comparator: Placebo (Part C)
Placebo administered SC and/or IV.
|
Administered SC and/or IV.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline up to Day 186
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3844583
Time Frame: Pre-dose on Day 1 up to 186 days post-dose
|
PK: 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
Time Frame: Pre-dose on Day 1 up to 186 days post-dose
|
PK: AUC of LY3844583
|
Pre-dose on Day 1 up to 186 days post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2022
Primary Completion (Actual)
January 20, 2024
Study Completion (Actual)
January 20, 2024
Study Registration Dates
First Submitted
August 2, 2022
First Submitted That Met QC Criteria
August 2, 2022
First Posted (Actual)
August 3, 2022
Study Record Updates
Last Update Posted (Estimated)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18365
- J3V-MC-KKAA (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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