A study to test whether spesolimab prevents flare-ups in patients with generalised pustular psoriasis.
About this study
Generalised pustular psoriasis is a rare skin disorder that presents with flares of widespread pustules on a background of red and tender skin. It can be treated with special creams for the skin, tablets or injections.
The investigational drug for this study is called spesolimab and is given as an injection into the skin.
The purpose of this research project is to measure how safe and effective this medication is in treating participants with generalised pustular psoriasis. Prior research studies in humans have shown that this medication may help control the immune system that is responsible for the signs and symptoms of generalised pustular psoriasis and help achieve disease improvement.
Who can take part
Inclusion criteria
- History of generalised pustular psoriasis with previous flares of disease, but stable at time of randomisation (when first receive study medication)
Exclusion criteria
- Other co-existing health conditions that may increase risk to patient in participating such as infections of the liver or tuberculosis
- Cancer in the past 5 years, not including common skin cancers that have been adequately treated
What's involved
- Chest x-ray, blood and urine samples, ECG, weight, blood pressure
- Monthly visits with more frequent visits if flare up of disease
- Skin checks
- Regular injections into the skin
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.