A study to test whether bimekizumab helps people with a skin disease called hidradenitis suppurativa.
About this study
Hidradenitis 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 for this study is called bimkizumab 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 HS. 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 HS and help achieve disease improvement.
Anticipated enrolment close date: TBD
Who can take part
Inclusion criteria
- Have a total abscess and inflamed skin nodule count of more than 5 in two different areas of your body and moderate HS for at least 6 months
- Must have had an inadequate response to oral antibiotics for HS
Exclusion criteria
- Presence of skin lesion due to reasons other than HS that stop accurate assessment of your HS
- Any other medical conditions that suppress the immune system or require treatment with other medications that dampen the immune system
What's involved
- Chest x-ray
- Blood/urine samples
- ECG
- Weight
- Blood pressure
- Visits to site every second week for 48 weeks
- 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.
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