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LY3844583 for Atopic Dermatitis/Eczema
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose on day 1 up to 186 days post-dose
Awards & highlights
Study Summary
This trial is testing a new drug for safety and how well it works in people with and without a skin condition.
Who is the study for?
This trial is for healthy adults and those with atopic dermatitis (eczema). Healthy participants can be of any gender but must not have the potential to bear children. People of Japanese descent must be first-generation with a specific body size, while Chinese participants need to be at least third-generation with certain body criteria. Participants with eczema should meet disease duration requirements and agree to use daily moisturizer.Check my eligibility
What is being tested?
The study tests LY3844583's safety and how it affects the body in both healthy individuals and those with atopic dermatitis compared to a placebo. The trial has three parts, each lasting between 88-186 days, involving up to 14 visits. It measures how quickly LY3844583 enters the blood and its elimination rate.See study design
What are the potential side effects?
While specific side effects are not listed, generally such trials look out for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious ones like allergic reactions or changes in lab results indicative of organ stress.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose on day 1 up to 186 days post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose on day 1 up to 186 days post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
Secondary outcome measures
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3844583
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3844583
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3844583 (Part C)Experimental Treatment1 Intervention
Repeat doses of LY3844583 administered SC and/or IV.
Group II: LY3844583 (Part B)Experimental Treatment1 Intervention
Multiple doses of LY3844583 administered SC and/or IV.
Group III: LY3844583 (Part A)Experimental Treatment1 Intervention
Single doses of LY3844583 administered subcutaneously (SC) and/or intravenously (IV).
Group IV: Placebo (Part A)Placebo Group1 Intervention
Placebo administered SC and/or IV.
Group V: Placebo (Part B)Placebo Group1 Intervention
Placebo administered SC and/or IV.
Group VI: Placebo (Part C)Placebo Group1 Intervention
Placebo administered SC and/or IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3844583
2022
Completed Phase 1
~110
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,827 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you want to join the study as a healthy Japanese participant, you need to have Japanese ancestry and meet specific body mass index requirements.Chinese participants must have at least third-generation Chinese ancestry and meet specific body mass index requirements to be included in the study.You have not had cancer in the last 5 years, unless there are specific exceptions.
Research Study Groups:
This trial has the following groups:- Group 1: LY3844583 (Part A)
- Group 2: LY3844583 (Part B)
- Group 3: LY3844583 (Part C)
- Group 4: Placebo (Part A)
- Group 5: Placebo (Part B)
- Group 6: Placebo (Part C)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I join the experiment as a participant?
"This clinical trial is in search of 86 patients who suffer from infantile eczema and are aged between 18 and 65."
Answered by AI
Could anyone aged 35 or over be admitted to this experiment?
"This trial is accepting volunteers between the age of majority and 65 years old."
Answered by AI
What is the cap for enrolling participants in this trial?
"Absolutely. Clinicaltrials.gov displays that this experiment, which was first shared on August 11th 2022, is presently recruiting patients. A total of 86 individuals need to be enrolled from 1 site."
Answered by AI
Is the opportunity to join this research still available for potential participants?
"Affirmative. According to information from clinicaltrials.gov, this medical experiment is presently looking for eligible patients; the trial was posted on August 11th 2022 and last modified on August 17th 2022. A total of 86 participants are required across 1 centre."
Answered by AI
Has the federal government sanctioned LY3844583 for use?
"The safety of LY3844583 was assessed at 1 due to the lack of data attesting its efficacy and limited evidence regarding its potential risks."
Answered by AI
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