This clinical trial seeks to assess the safety and effectiveness of Barzolvolimab in participants with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite use of antihistamine treatment.
About this study
CSU is a skin condition characterised by hives that are chronic and persist for at least six weeks with no identifiable cause (spontaneous). This study will test the effectiveness and safety of barzolvolimab (at two different doses) to see if it helps people with CSU haven't responded to antihistamines.
Who can take part
This trial might be right for you if you:
- are aged 18 years or older
- have a diagnosis of CSU for at least 6 months
- are not responding to current treatments
You may not be eligible if you:
- have other diseases that cause similar symptoms to CSU (like hives or swelling)
- your hives are triggered by physical factors like scratching, cold, heat, sunlight, pressure, water, exercise, or touch, and this would interfere with the study’s assessments
- have other active skin diseases that cause itching and could interfere with the study
- have received UV light therapy (UVA or UVB) in the last 4 weeks
- are pregnant or breastfeeding. Women who can get pregnant must take a pregnancy test before starting.
What's involved
- Attend the RMH about 20 times over the 16 month trial period (One year and four months). Most study visits will take approximately one hour, however your first two visits will be between 1.5 to 2 hours
- Medical history, physical examination, height, and weight
- Provide blood and urine samples
- Answer some questionnaire relating to your condition
- Complete electronic diary daily at the same time, preferably in the morning
- ECG tests
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.