What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly biologic agents like monoclonal antibodies targeting IL-13 (e.g., Tralokinumab) and IL-4/IL-13 (e.g., Dupilumab), have known side effects. These can include injection site reactions, conjunctivitis, and eosinophilia. Dupilumab has also been associated with facial redness and new-onset head and neck dermatitis. Other treatments, such as Janus kinase inhibitors (e.g., Tofacitinib, Ruxolitinib), may cause infections, headaches, and increased liver enzymes. Traditional treatments like topical corticosteroids can lead to skin thinning and systemic absorption issues if used long-term.

What prior FDA approvals exist?

Dupilumab, a monoclonal antibody targeting the IL-4 receptor alpha, has been FDA-approved for the treatment of moderate to severe atopic dermatitis. It works by inhibiting the signaling of both IL-4 and IL-13, which are key cytokines involved in the inflammatory response associated with atopic dermatitis. This makes it similar to Eblasakimab, which targets the IL-13 receptor. Other systemic treatments for atopic dermatitis include cyclosporine and methotrexate, although these are not biologics. The approval of Dupilumab has paved the way for the development and study of other biologic treatments targeting similar pathways.

What other types of research exist?

Promising novel alternatives to Eblasakimab for Atopic Dermatitis patients include Dupilumab (targets IL-4 and IL-13), Tralokinumab (targets IL-13), and Upadacitinib (a JAK inhibitor). These treatments have demonstrated efficacy and safety in clinical trials and are viable options for AD management.

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Monoclonal Antibodies

Eblasakimab for Eczema

Phase 2

Recruiting

Research Sponsored by Aslan Pharmaceuticals

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 week 16 and week 24

Awards & highlights

Summary

This trial is testing a new medication called eblasakimab for people with moderate-to-severe atopic dermatitis who have already tried another treatment called dupilumab. The medication aims to reduce skin inflammation and improve symptoms. The study will last for several months, including a treatment period and a follow-up.

Who is the study for?

Adults with moderate-to-severe atopic dermatitis who've tried Dupilumab without success can join. They should have a significant area of skin affected, a certain severity score, and be able to follow the study plan. Excluded are those on recent immunotherapies or drugs that affect the immune system, uncontrolled asthma or chronic diseases, liver issues, HIV, hepatitis B/C infections, active COVID-19 infection.

What is being tested?

The trial is testing Eblasakimab (ASLAN004) against a placebo in people with stubborn eczema despite previous treatment. Participants will randomly receive either the drug or placebo for 16 weeks and then be monitored for another 8 weeks to check effectiveness and safety.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include irritation at injection sites, allergic reactions to ingredients in Eblasakimab or placebos used during trials. Monitoring will occur throughout the study for any adverse effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16 and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16 and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 and week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16

Secondary study objectives

Absolute and percent change in peak Pruritus Numerical Rating Scale (P-NRS)

Absolute and percent change in sleep disturbance numerical rating scale (SD-NRS)

Change in Body Surface Area (BSA) affected with AD

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ASLAN004Experimental Treatment1 Intervention

Week 0, 1: LD of 600 mg; Week 2 through Week 15 QW: 400 mg dose

Group II: PlaceboPlacebo Group1 Intervention

Placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every week (QW) from Week 2 to Week 15

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASLAN004

2018

Completed Phase 2

~400

Do I qualify?Apply below to find out

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

Atopic Dermatitis (AD) treatments often target specific immune pathways to reduce inflammation and alleviate symptoms. Biologic agents like Eblasakimab, which targets the IL-13 receptor, work by inhibiting cytokines involved in the inflammatory process. IL-13 is a key cytokine in the pathogenesis of AD, contributing to skin barrier dysfunction and chronic inflammation. By blocking IL-13, Eblasakimab and similar treatments can significantly reduce the severity of AD symptoms. This targeted approach is crucial for AD patients as it offers a more effective and tailored treatment option, potentially with fewer side effects compared to traditional systemic therapies.

Find a Location

Who is running the clinical trial?

Aslan PharmaceuticalsLead Sponsor

19 Previous Clinical Trials

1,375 Total Patients Enrolled

ASLAN PharmaceuticalsLead Sponsor

20 Previous Clinical Trials

1,435 Total Patients Enrolled

Chief Medical OfficerStudy DirectorASLAN Pharmaceuticals

124 Previous Clinical Trials

21,756 Total Patients Enrolled

Media Library

ASLAN004 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05694884 — Phase 2

Atopic Dermatitis Research Study Groups: ASLAN004, Placebo

Atopic Dermatitis Clinical Trial 2023: ASLAN004 Highlights & Side Effects. Trial Name: NCT05694884 — Phase 2

ASLAN004 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05694884 — Phase 2

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