Zabedosertib for Eczema

(Damask Trial)

Recruiting at 32 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

77 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What makes the drug Zabedosertib unique for treating eczema?

Zabedosertib (BAY1834845) is a novel treatment for eczema that may offer a different mechanism of action compared to traditional therapies like topical steroids and immunomodulators, which often have concerns about long-term side effects. While specific details about Zabedosertib's mechanism are not provided, it represents an alternative to existing treatments that primarily focus on inflammation and barrier repair. ^{1 2 3 4 5}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

An Appropriate Response to the Black-Box Warning: Corrective, Barrier Repair Therapy in Atopic Dermatitis. [2021]

2. Austria pubmed.ncbi.nlm.nih.gov

[Topical immunomodulators for treatment of eczema]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Severe eczema in Wiskott-Aldrich syndrome-related disorder successfully treated with dupilumab. [2023]

4. United States 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 [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting Interleukin 13 for the Treatment of Atopic Dermatitis. [2023]