What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, which can cause skin thinning, striae, and telangiectasia with prolonged use. Topical calcineurin inhibitors like tacrolimus and pimecrolimus may cause burning sensations and increased risk of skin infections. Biologics such as dupilumab are associated with conjunctivitis, injection site reactions, and potential risk of infections. JAK inhibitors, another emerging treatment, can lead to nasopharyngitis and headaches. Anti-IL-31 antibodies like nemolizumab have shown mild adverse events, including exacerbation of atopic dermatitis and injection site reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis that target inflammatory and immunomodulatory pathways. Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, is widely used for moderate-to-severe cases. Other approved treatments include tralokinumab, which also targets IL-13, and the Janus kinase (JAK) inhibitors abrocitinib and upadacitinib, which modulate immune responses by inhibiting specific enzymes involved in the inflammatory process. These treatments have shown efficacy in reducing symptoms and improving the quality of life for patients with atopic dermatitis.

What other types of research exist?

Promising novel alternatives to EP262 for atopic dermatitis patients in 2024 include Dupilumab, an IL-4 receptor alpha antagonist; Tralokinumab, an IL-13 inhibitor; and Upadacitinib, a Janus kinase (JAK) inhibitor. These agents have shown significant efficacy in reducing symptoms and improving quality of life in clinical trials.

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EP262 for Eczema (EASE Trial)

Phase 2

Waitlist Available

Research Sponsored by Escient Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year

BSA of 3% to 20% and a vIGA-AD score of ≥3

Must not have

Use of specific treatments for atopic dermatitis

Clinically infected atopic dermatitis that requires antibiotic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from day 1 to end of study or early termination (up to 10 weeks)

Summary

This trial will test a new treatment called EP262 to see if it can help people with atopic dermatitis by reducing their symptoms.

Who is the study for?

This trial is for people with atopic dermatitis (eczema) covering 3-20% of their body and a moderate to severe score on a skin assessment. They must have had eczema for at least one year but can't join if they need antibiotics for an infection or have other itchy skin diseases.

What is being tested?

The study tests EP262, an oral medication, against a placebo (a pill without active medicine). Participants won't know which one they're taking. The goal is to see how safe EP262 is and how it affects the body in those with eczema.

What are the potential side effects?

Possible side effects are not detailed here, but generally could include reactions related to the immune system since EP262 targets atopic dermatitis, which involves immune dysregulation.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with active atopic dermatitis for over a year.

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My skin condition affects 3% to 20% of my body and is moderately severe.

Exclusion Criteria

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

Select...

I am using specific treatments for my eczema.

Select...

I have a skin condition needing antibiotics.

Select...

I have a skin condition that causes long-term itching.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from day 1 to end of study or early termination (up to 10 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured from day 1 to end of study or early termination (up to 10 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from day 1 to end of study or early termination (up to 10 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability of EP262

Secondary study objectives

Effect of EP262 on skin gene expression

Effect of EP262 on skin histology

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EP262 150 mgExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral EP262

2023

Completed Phase 2

~40

0 / 5Eligibility 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) include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and biologics such as dupilumab. Topical corticosteroids reduce inflammation by inhibiting multiple inflammatory cytokines. Calcineurin inhibitors block T-cell activation, thereby reducing the immune response that contributes to AD. Dupilumab, a monoclonal antibody, targets the IL-4 and IL-13 pathways, which are crucial in the inflammatory process of AD. These treatments are essential for AD patients as they help to control the chronic inflammation and immune dysregulation that characterize the disease, thereby reducing symptoms and improving quality of life.

Recent developments in atopic dermatitis.