Zabedosertib for Eczema

(Damask Trial)

No longer recruiting at 39 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bayer

Must be taking: Emollients

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: Infections, Uncontrolled conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the new treatment, zabedosertib, for individuals with atopic dermatitis, commonly known as eczema. The treatment seeks to calm the immune system, reducing skin inflammation and improving symptoms such as itching and redness. Participants will receive either zabedosertib or a placebo (a non-active substance) for comparison. The trial seeks individuals who have experienced moderate-to-severe eczema for at least a year and have not found relief with typical treatments like topical steroids. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop using topical treatments for eczema 7 days before starting, and any systemic immune therapies or phototherapy 4 weeks before starting. If you are on biologic drugs, you need to stop them for a period based on the drug's half-life before joining the trial.

Is there any evidence suggesting that zabedosertib is likely to be safe for humans?

Research has shown that zabedosertib, a new treatment being tested for eczema, has promising safety results. In earlier studies, participants generally tolerated zabedosertib well, and it usually did not cause serious side effects. Some studies found that it effectively reduced inflammation symptoms without causing major problems. However, since testing continues, researchers are closely monitoring its safety and gathering more information to ensure it remains safe over time. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard eczema treatments, which often include topical corticosteroids and immunosuppressants, zabedosertib acts on a different pathway. Researchers are excited about this treatment because it targets specific cellular processes involved in inflammation, potentially offering a new way to manage eczema symptoms. This unique approach could mean fewer side effects and improved outcomes for patients who don't respond well to existing therapies.

What evidence suggests that zabedosertib might be an effective treatment for eczema?

Research has shown that zabedosertib, which participants in this trial may receive, might help treat atopic dermatitis, or eczema, by reducing inflammation. This treatment lowers the activity of a protein called IRAK4, which contributes to inflammation in the body. Studies have found that zabedosertib effectively reduces inflammation, offering hope for people with eczema. In tests, it also lessened the severity and spread of skin problems in other inflammatory skin conditions. Although more research is needed, these early findings suggest that zabedosertib could be promising for easing eczema symptoms. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with atopic dermatitis for at least one year before the screening visit.

You have tried using corticosteroid cream and it didn't work, or your doctor thinks it's not safe for you to use it.

You have been using a certain lotion on your whole body twice a day for at least 7 days before the study starts.

Exclusion Criteria

You have had a serious infection or are currently dealing with a significant viral, bacterial, fungal, or parasitic infection within the past 3 months.

Known hypersensitivity to the study drug

You have recently been treated with a biologic drug, within a certain period of time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

2 visits (in-person)

Treatment

Participants receive zabedosertib or placebo for up to 12 weeks

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Zabedosertib (BAY1834845)

Trial Overview 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.

How Is the Trial Designed?

Group I: Zabedosertib Experimental Treatment 1 Intervention

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

Group II: Matching placebo to zabedosertib Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

Dupilumab significantly improved key measures of atopic dermatitis, such as the Eczema Area and Severity Index (EASI) and Peak Pruritus NRS, in White and Asian patients, as well as in Black/African American patients, demonstrating its efficacy across different racial subgroups.

The treatment was generally well tolerated with a favorable safety profile, as serious adverse events were more common in the placebo group, indicating that dupilumab is a safe option for managing moderate-to-severe atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials Alexis, AF., Rendon, M., Silverberg, JI., et al.[2022]

Targeted therapies, particularly interleukin 13 (IL-13) inhibitors like tralokinumab, have shown promising efficacy and safety for treating moderate-to-severe atopic dermatitis (AD), addressing the limitations of conventional therapies.

There is a significant unmet need for effective long-term treatments for refractory AD, and the emergence of biologic agents offers new options that can improve patient outcomes and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Interleukin 13 for the Treatment of Atopic Dermatitis. Lytvyn, Y., Gooderham, M.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40906353/

Efficacy and Safety of Zabedosertib, an Interleukin-1 ... Efficacy and Safety of Zabedosertib, an Interleukin-1 Receptor-Associated Kinase 4 Inhibitor, in Patients with Moderate-to-Severe Atopic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05656911

NCT05656911 | A Study to Learn How Well the ... To answer this, the researchers will compare how many participants had 75% EASI score reduction after 12 weeks treatment between participants treated with ...

3. link.springer.com link.springer.com/article/10.1007/s13555-025-01505-z

Efficacy and Safety of Zabedosertib, an Interleukin-1 ... Zabedosertib was also effective in reducing the Canine Atopic Dermatitis Extent and Severity Index and itch in two field studies in dogs with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955609/

The oral IRAK4 inhibitors zabedosertib and BAY1830839 ... This study demonstrated the pharmacological effectiveness of BAY1834845 and BAY1830839 in suppressing systemically and locally induced inflammatory responses.

5. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2022-000520-38/FR

Clinical Trials Register The secondary objective is to assess the safety and tolerability of zabedosertib vs. placebo. E.2.3, Trial contains a sub-study, No. E.3 ...

6. clinicaltrials.bayer.com clinicaltrials.bayer.com/study/21329

Immune mediated inflammatory diseases | Study 21329 Before a treatment is available to all patients, researchers study it in trials to better understand its safety and how well it works. In this trial, the ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05656911/a-study-to-learn-how-well-the-study-treatment-zabedosertib-bay1834845-works-and-how-safe-it-is-compared-to-placebo-in-adult-participants-with-moderate-to-severe-atopic-dermatitis?activelyRecruiting=false&page=84&id=770&slug=dermatitis-atopic

A Study to Learn How Well the Study Treatment ... A Study to Learn How Well the Study Treatment Zabedosertib (BAY1834845) Works and How Safe it is Compared to Placebo in Adult Participants With Moderate-to- ...