A clinical trial to assess a new drug called ligelizumab for the treatment of chronic spontaneous urticaria (CSU).
About this study
Chronic spontaneous urticaria (CSU) is defined as the spontaneous occurrence of itchy wheals (hives), swelling of the skin, or both lasting for at least 6 weeks. This study is testing a new treatment for CSU called ligelizumab. The purpose of this study is to evaluate the safety and effectiveness of ligelizumab in treating patients with CSU.
Sometimes we do not know which treatment is best for treating a condition. To find out we need to compare different treatments. This study puts patients into groups and gives each group a different treatment. The results are compared to see if one is better.
The effectiveness of ligelizumab will be determined by comparing its effect to standard of care drug omalizumab and a placebo.
Ligelizumab, omalizumab and the placebo will be administered via an injection at regular intervals.
Who can take part
Inclusion criteria
- Patients must be 12 years of age or older
- Have had diagnosis of CSU for longer than 6 months
- Diagnoses of CSU not responsive to anti-histamines
Exclusion criteria
Patients cannot participate if they have a clearly defined cause of their urticaria or have previously used omalizumab
What's involved
- 20 visits over 15 months
- Blood and urine samples
- Injections
- Chest x-ray
- Weight measured
- Blood pressure measured
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.