A clinical trial to assess a new drug for chronic spontaneous urticaria (CSU) not controlled with antihistamine medication or omalizumab (Xolair®) in the past.
About this study
Chronic spontaneous urticaria is a condition that is characterised by the appearance of weals (hives) and angioedema (swelling in the skin) that occur without a clear trigger. The drug we are studying for this project is called remibrutinib and will be provided to participants in the form of an oral tablet.
The purpose of this project is to measure how safe and effective this medication is in treating participants with chronic spontaneous urticaria.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.