22158 Damask
Research type
Research Study
Full title
A randomized, placebo-controlled, double-blind, parallel-group, multicenter Phase 2a study to investigate efficacy and safety of zabedosertib (BAY 1834845) for the treatment of adult patients with moderate-to-severe atopic dermatitis
IRAS ID
1006473
Contact name
Merja Sariola-Heiner
Contact email
Sponsor organisation
Bayer AG
Eudract number
2022-000520-38
Clinicaltrials.gov Identifier
Research summary
Atopic dermatitis is a disease where – beside other factors - your immune system – the body system that usually fights infections overreacts and leads to an inflammation of the skin instead. It can lead to various symptoms like redness, eczema and severe itch.
The study treatment Zabedosertib inhibits a certain protein, Interleukin receptor-associated kinase 4(“IRAK4”) which is considered to promote the inflammatory reaction in atopic dermatitis. Therefore it is expected that Zabedosertib may reduce the inflammatory reactions and improve skin conditions.In this study, the researchers will look how well Zabedosertib works compared to a placebo in participants with atopic dermatitis and learn how safe the new medication is. In order to investigate the efficacy of Zabedosertib, the doctor will complete three clinical assessments of the skin condition at several on-site visits. In addition, the study participant will be asked to daily assess how much they have been itching in one numerical rating scale questionnaire. Study participants will receive either Zabedosertib or placebo for 12 weeks.
During the study, the participants will visit their study site approximately 8 times. Each participant will be in the study for approximately 18 to 20 weeks with screening and follow up phase of the study. During the study, the participants will :
- Take one tablet of study medication each morning and evening
- Record their worst itch in the past 24h, using a numeric rating scale and record each study drug intake in an electronic device
The doctors will :
- Check participant´s health, how the treatment is tolerated and assess participant atopic dermatitis regularly
- Take blood and urine samples and 2 skin samples if the patient agrees to participate optional biopsy sub-study
- Ask the participant questions about what medicine they are taking and if they are having adverse eventsREC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0263
Date of REC Opinion
5 Jan 2023
REC opinion
Further Information Favourable Opinion