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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)

Awards & highlights

Damask Trial Summary

This trial is to compare the efficacy and safety of zabedosertib to placebo in people with atopic dermatitis.

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.Check my eligibility

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.See study design

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.

Damask Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Absolute change from baseline in body surface area (BSA) affected by atopic dermatitis (AD) at Week 12 (Day 84)

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

+6 more

Damask 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

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,901 Total Patients Enrolled

Media Library

Zabedosertib (BAY1834845) (IRAK4 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05656911 — Phase 2

Atopic Dermatitis Research Study Groups: Matching placebo to zabedosertib, Zabedosertib

Atopic Dermatitis Clinical Trial 2023: Zabedosertib (BAY1834845) Highlights & Side Effects. Trial Name: NCT05656911 — Phase 2

Zabedosertib (BAY1834845) (IRAK4 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656911 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavour welcome participants aged 75 or above?

"Patients aged 18 to 65 are eligible for this medical trial. Separate trials exist for those under the age of 18 (102) and over 65 (168)."

Answered by AI

Is the enrollment period still open to prospective participants?

"Clinicaltrials.gov indicates that this medical trial is no longer recruiting participants, having been posted on December 21st 2022 and last updated a week later. Despite not being able to join this research project, there are still 237 other options which are actively seeking candidates at the moment."

Answered by AI

How many healthcare institutions are carrying out this clinical trial?

"There are four main sites conducting this medical trial: Harvard Medical School -Beth Israel Deaconess Medical Center in Boston, University of Cincinnati College of Medicine - Dermatology in Cincinnati, and Arlington Research Center, INC. in Arlington with additional locations available."

Answered by AI

Has Zabedosertib obtained governmental authorization for marketability?

"The safety of Zabedosertib has been evaluated and assigned a score of 2. This is due to the relatively limited evidence supporting its efficacy, as this clinical trial is currently in Phase 2."

Answered by AI

Who is eligible to join in this research project?

"This trial is seeking 72 participants with dermatitis between the ages of 18 to 65 years old. To be eligible, applicants must have a peak pruritus numerical rating scale (NRS) score ≥ 4, documented history of inadequate response to treatment with topical corticosteroids, consistent use of emollients on two occasions daily for seven days prior to randomization visit, BMI range from 18.5-35kg/m2 at screening and randomisation visits, diagnosis of AD for a year or more at screening visit, moderate-to-severe AD as defined by Eczema Area and Severity Index (EASI) score"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05656911.