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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
Summary
This trial is testing a new drug called LY3844583 to see if it is safe and well-tolerated. The study includes both healthy people and those with atopic dermatitis. Researchers will check how fast the drug gets into the blood and how long it stays there.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and biologics like dupilumab. These treatments work by modulating the immune response and reducing inflammation.
Topical corticosteroids inhibit multiple inflammatory cytokines, while calcineurin inhibitors block T-cell activation. Dupilumab, a monoclonal antibody, inhibits the IL-4 and IL-13 pathways, which are crucial in the inflammatory process of AD.
Understanding these mechanisms is important for patients as it helps in selecting the most appropriate treatment based on the severity and specific characteristics of their condition.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,651 Previous Clinical Trials
3,224,365 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,369 Previous Clinical Trials
421,292 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.
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