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.
Anticipated enrolment close date: January 2023
Who can take part
Inclusion criteria
You may be able to participate if you meet the following criteria:
- A diagnosis of CSU for greater than six months before screening for this study
- Ongoing CSU despite using oral antihistamine medication
- If you were previously treated with omalizumab (Xolair®) you may be eligible to participate
Exclusion criteria
You may not participate if any of the following apply to you:
- Diagnosis of urticaria is caused by a clear trigger
- Use of medications that suppress the immune system within four weeks of starting trial
- Use of anticoagulant medications to thin the blood
What's involved
Study requirements:
- Participation in the study for about 14 months
- Attend the RMH about 13 times during this period. Most study visits should take about one hour, however, your first visit to the study site and visits at weeks 2, 12 and 52 will be longer
- Medical history
- Physical examination (for example, height and weight)
- Provide blood and urine samples
For the first six months you will randomly be assigned to receive either:
- Remibrutinib (you have a 2 in 3 chance of getting this treatment), or
- Placebo (you have a 1 in 3 chance of getting the placebo)
After the first six months, all participants will receive remibrutinib, taken orally twice a day.
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.