A clinical trial to assess the safety and effectiveness of a new drug for hidradenitis suppurativa.
About this study
Hidradeninitis suppurativa (HS) is a chronic inflammatory debilitating skin condition characterised by painful, deep skin lesions commonly under the arms or in the groin area. It can be treated with topical treatments on the skin, tablets, injections or infusions.
The investigational drug is given as an injection into the skin and targets one part of the pathway involved in HS.
The purpose of this research project is to measure how safe and effective this medication is in treating participants with hidradenitis suppurativa. 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 hidradenitis suppurativa and help achieve disease improvement.
Who can take part
- Have a diagnosis of hidradenitis suppurativa (HS) for 6 months
- Have skin changes consistent with HS in at least two different areas of your body
- Have previously been treated with oral antibiotics but this was not effective
- More than 20 skin lesions that are actively draining
- Have previously received any medication for treatment of HS called biologic medications
- Chest x-ray
- Blood samples
- Urine samples
- Electrocardiogram (ECG)
- Blood pressure
- 10 clinical trial visits
- Skin checks
- Regular injections into the skin
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.