What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, calcineurin inhibitors (such as tacrolimus and pimecrolimus), and newer biologics like dupilumab. Topical corticosteroids can cause skin thinning, stretch marks, and systemic effects if used long-term. Calcineurin inhibitors may lead to burning sensations, itching, and increased risk of skin infections. Dupilumab, a monoclonal antibody, can cause injection site reactions, conjunctivitis, and rarely, facial redness. Other treatments like JAK inhibitors and phosphodiesterase inhibitors, similar to LY3844583, may cause nasopharyngitis, headache, and gastrointestinal symptoms. Overall, while these treatments are generally well-tolerated, they can have mild to moderate side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis that focus on safety, tolerability, and pharmacokinetics. Notable among these are dupilumab, a monoclonal antibody that targets the IL-4 receptor and has shown efficacy in reducing symptoms of AD, and topical phosphodiesterase 4 inhibitors like crisaborole, which reduce inflammation. Other systemic treatments include cyclosporine and methotrexate, which are immunosuppressants used for severe cases. These treatments have been evaluated for their pharmacokinetics, safety, and tolerability, similar to the ongoing studies for LY3844583.

What other types of research exist?

Promising novel alternatives to LY3844583 for atopic dermatitis include: 1) Topical phosphodiesterase 4 inhibitor E6005, which has shown safety and efficacy in Japanese children with mild-to-moderate atopic dermatitis. 2) Biologic agents such as dupilumab, which targets the IL-4 receptor and has been effective in moderate-to-severe cases. 3) Janus kinase (JAK) inhibitors like tofacitinib, which have shown efficacy in other dermatological conditions and are being explored for atopic dermatitis.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on day 1 up to 186 days post-dose for reporting.

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.

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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.