What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis include topical corticosteroids, topical calcineurin inhibitors, and systemic immunosuppressants like methotrexate and cyclosporine. Known side effects of topical corticosteroids include skin thinning, irritation, and redness. Topical calcineurin inhibitors can cause burning and itching at the application site. Systemic treatments like methotrexate and cyclosporine may lead to gastrointestinal discomfort, liver toxicity, and increased risk of infections. For treatments similar to Etrasimod, such as other systemic immunomodulators, side effects can include headache, nasopharyngitis, and potential immune system suppression.

What prior FDA approvals exist?

The FDA has approved several systemic treatments for Atopic Dermatitis, including biologics and small molecules. Dupilumab, an IL-4 receptor alpha antagonist, was one of the first biologics approved for moderate-to-severe AD. More recently, JAK inhibitors like abrocitinib and upadacitinib have been approved for their efficacy in reducing inflammation and symptoms in AD patients. While Etrasimod, an S1P receptor modulator, is still under investigation, these approved treatments highlight the ongoing advancements in systemic therapies for AD.

What other types of research exist?

Promising novel alternatives to Etrasimod for Atopic Dermatitis patients include Dupilumab, a monoclonal antibody targeting the IL-4 receptor, and Upadacitinib, a JAK inhibitor. Both have shown significant efficacy in clinical trials for moderate-to-severe AD and are expected to be key treatment options in 2024.

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Sphingosine-1-Phosphate Receptor Modulator

Etrasimod for Eczema

Phase 2 & 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening

Moderate to severe AD: IGA score ≥3 at screening and baseline, BSA ≥10% of AD involvement at screening and baseline, Eczema Area and Severity Index (EASI) ≥16 at screening and baseline

Must not have

Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 68 weeks in part 1 and up to 52 weeks in part 2

Summary

This trial is testing a daily pill called etrasimod to treat adults with moderate to severe eczema who haven't had success with other treatments. The study will compare the effects of etrasimod to see if it is safe and effective. Participants will have periodic clinic visits to monitor their health and symptoms.

Who is the study for?

Adults aged 18-80 with moderate to severe atopic dermatitis (AD), also known as eczema, who have not seen improvement after trying systemic therapies. Participants must have had AD for at least a year and be willing to use daily moisturizers throughout the study.

What is being tested?

The trial is testing Etrasimod, an oral medication, against a placebo in adults with AD. Part 1 randomly assigns participants to either drug or placebo for 16 weeks; some may continue Etrasimod for another 52 weeks. Part 2 involves all participants taking Etrasimod for one year.

What are the potential side effects?

Potential side effects of Etrasimod include reactions related to immune system changes since it affects how certain cells work in the body. This could lead to increased risk of infections or other immune-related issues.

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 chronic eczema for over a year.

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My eczema is moderate to severe, covering more than 10% of my body.

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I have tried a treatment for my condition before and it didn't work.

Exclusion Criteria

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

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I do not have a serious infection or need treatment for one that could affect the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 68 weeks in part 1 and up to 52 weeks in part 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 68 weeks in part 1 and up to 52 weeks in part 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 68 weeks in part 1 and up to 52 weeks in part 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1 DB: Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline

Part 1 OLE and Part 2: Incidence and severity of treatment-emergent adverse events (AEs), AEs leading to study treatment discontinuation, serious AEs, and AEs of special interest.

Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L)

+18 more

Secondary study objectives

Part 1 DB: Percent change from baseline in EASI

Part 1 DB: Proportion of participants achieving a EASI-75

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: etrasimodExperimental Treatment1 Intervention

2 mg, oral tablet, once daily

Group II: Placebo (Part 1 DB period only)Placebo Group1 Intervention

Oral sham comparator

0 / 4Eligibility 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, and systemic immunomodulators. Topical corticosteroids reduce inflammation by inhibiting multiple inflammatory cytokines, providing quick relief from itching and redness. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, block T-cell activation, reducing immune responses that cause skin inflammation. Systemic treatments like dupilumab, a monoclonal antibody, target specific pathways like the IL-4 and IL-13 signaling, crucial in the inflammatory process of AD. Etrasimod, an S1P receptor modulator, works by modulating immune cell trafficking, potentially reducing inflammation and immune response. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the severity and specific characteristics of the patient's AD.