What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis that target inflammatory pathways include biologics like dupilumab, JAK inhibitors such as baricitinib, and monoclonal antibodies like nemolizumab and lebrikizumab. Known side effects of dupilumab include injection site reactions, conjunctivitis, and facial redness. JAK inhibitors like baricitinib can cause nasopharyngitis and headaches. Nemolizumab may lead to mild adverse events such as exacerbation of atopic dermatitis, Meniere's disease, and peripheral edema. Lebrikizumab's side effects are generally mild but can include injection site reactions and upper respiratory infections. These treatments are generally well-tolerated, but long-term safety data is still being evaluated.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of atopic dermatitis include dupilumab, an IL-4 receptor alpha antagonist, which has shown significant efficacy and safety in clinical trials for moderate-to-severe cases. Additionally, JAK inhibitors such as baricitinib and upadacitinib have been approved, targeting inflammatory pathways to modulate the immune response and reduce inflammation. These treatments are similar to LY3454738, which is also being studied for its potential to target inflammatory pathways in atopic dermatitis.

What other types of research exist?

A promising, novel alternative to LY3454738 for treating atopic dermatitis is LX519290, a synthetic derivative that has shown potential in reducing atopic dermatitis symptoms in preclinical studies.

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Monoclonal Antibodies

LY3454738 for Atopic Dermatitis

Phase 2

Recruiting

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

Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit: EASI score ≥16, vIGA-AD score ≥3, and ≥10% of BSA involvement (per EASI BSA)

Be older than 18 years old

Must not have

Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called LY3454738 to see if it helps adults with serious cases of atopic dermatitis. The goal is to find out if it can safely reduce symptoms like itching and inflammation.

Who is the study for?

This trial is for adults with moderate-to-severe atopic dermatitis (AD), who need systemic therapy. Participants should have an EASI score of 16 or more, a vIGA-AD score of at least 3, and AD affecting 10% or more of their body. They must use emollients daily for two weeks before and throughout the study. Those with certain skin conditions, infections, medical issues, or recent treatments are excluded.

What is being tested?

The trial is testing LY3454738's effectiveness and safety in treating AD compared to a placebo. Participants will be randomly assigned to receive either the investigational drug LY3454738 or a placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects aren't listed here, common side effects from drugs like LY3454738 may include irritation at the injection site, headache, fatigue, nausea and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe eczema with a high EASI score, vIGA-AD score, and it covers more than 10% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any listed skin conditions, infections, or serious health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3454738 Dose 3Experimental Treatment1 Intervention

Participants will receive LY3454738 SC.

Group II: LY3454738 Dose 2Experimental Treatment1 Intervention

Participants will receive LY3454738 SC.

Group III: LY3454738 Dose 1Experimental Treatment1 Intervention

Participants will receive LY3454738 subcutaneously (SC).

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3454738

2024

Completed Phase 1

~160

0 / 2Eligibility criteria met

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) that target inflammatory pathways include biologics like dupilumab and small molecules like JAK inhibitors. Dupilumab works by inhibiting the IL-4 and IL-13 pathways, which are crucial in the inflammatory process of AD. JAK inhibitors, such as abrocitinib and upadacitinib, block the Janus kinase pathways, reducing the activity of multiple cytokines involved in AD. These treatments are significant for patients because they offer targeted therapy that can reduce inflammation, improve skin symptoms, and enhance the quality of life for those with moderate-to-severe AD.

Recent developments in atopic dermatitis.