What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, such as Janus kinase inhibitors (e.g., delgocitinib) and systemic treatments like abrocitinib and dupilumab, often have side effects related to immune modulation. These can include nausea, headache, acne, nasopharyngitis, and increased risk of infections. Serious adverse effects, though less common, may include hypersensitivity reactions, serious infections, and in rare cases, conditions like nephrotic syndrome or rhabdomyolysis. Monitoring for adverse events is crucial during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis that modulate the immune system and reduce inflammation. Notably, dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling, has been approved for moderate-to-severe atopic dermatitis. Other systemic therapies include cyclosporine, methotrexate, and azathioprine, which are immunosuppressive agents. While specific IRAK4 inhibitors like zabedosertib are still under investigation, these approved treatments share a common goal of reducing immune system overactivity and inflammation in atopic dermatitis.

What other types of research exist?

Promising, novel alternatives to Zabedosertib for Atopic Dermatitis patients in 2024 include biologics such as Dupilumab, which targets the IL-4 and IL-13 pathways, and JAK inhibitors like Upadacitinib and Abrocitinib, which have shown efficacy in reducing inflammation and symptoms in AD patients. These treatments have been validated in clinical trials and offer targeted approaches to managing moderate-to-severe atopic dermatitis.

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IRAK4 Inhibitor

Zabedosertib for Eczema (Damask Trial)

Phase 2

Waitlist Available

Research Sponsored by Bayer

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 up to week 12 (day 84)

Summary

This trial is testing a new drug called zabedosertib to treat people with eczema, a skin condition that causes red, itchy patches. The drug works by calming down the immune system to reduce skin inflammation. Researchers will compare its effectiveness and safety over several months.

Who is the study for?

Adults aged 18-65 with moderate-to-severe atopic dermatitis (eczema) for over a year, who haven't responded well to topical steroids or can't use them. Participants should have been applying emollients consistently and meet certain severity scores on the EASI and other scales. They must not have severe infections recently, known drug hypersensitivity, recent major surgery, unstable health conditions, or be using certain medications.

What is being tested?

The trial is testing Zabedosertib (BAY1834845), which aims to reduce skin inflammation by targeting a protein involved in immune responses. Its effectiveness will be compared to a placebo over 12 weeks by measuring improvements in the Eczema Area and Severity Index score among participants.

What are the potential side effects?

Potential side effects are not specified but will be monitored throughout the study. Adverse events of any kind experienced during the trial will be recorded to assess safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 12 (day 84)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 12 (day 84)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 (day 84) 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 having achievement of 75% reduction from baseline in the Eczema Area and Severity Index (EASI 75 response) at Week 12 (Day 84)

Secondary study objectives

Absolute values of weekly average of the Peak Pruritus 0-10 numerical rating scale (NRS) score from baseline at Week 12 (Day 84)

Achievement of a ≥ 4 point-improvement (reduction) in the weekly average of the Peak Pruritus 0-10 NRS score from baseline to Week 12 (Day 84) for participants with Peak Pruritus 0-10 NRS score ≥ 4 at baseline

Number of participants having achievement of EASI 50 response at Week 12 (Day 84)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ZabedosertibExperimental Treatment1 Intervention

Participants will receive zabedosertib for up to 12 weeks (84 days).

Group II: Matching placebo to zabedosertibPlacebo Group1 Intervention

Participants will receive placebo to zabedosertib for up to 12 weeks (84 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zabedosertib (BAY1834845)

2022

Completed Phase 2

~80

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

Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors, and biologics like dupilumab. Topical corticosteroids reduce inflammation by suppressing the immune response. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, inhibit T-cell activation, thereby reducing inflammation and immune activity. Biologics like dupilumab target specific cytokines (e.g., IL-4 and IL-13) involved in the inflammatory process. Zabedosertib, an IRAK4 inhibitor, works by reducing the activity of IRAK4, a protein that promotes inflammation through immune cell activation. These mechanisms are crucial for AD patients as they help control the chronic inflammation and immune overreaction that cause the characteristic symptoms of AD, such as itching, redness, and skin lesions.

Recent developments in atopic dermatitis.