A clinical trial to assess a new drug called dupilumab for bullous pemphigoid (BP), a rare autoimmune skin condition characterised by blistering and itch.
About this study
Bullous pemphigoid (BP) is a rare, autoimmune skin condition characterised by blistering and itch. Many patients who have BP require treatment with topical steroids while others may require tablets, injections or infusions.
The investigational drug is dupilumab and is administered by injection.
The purpose of this research project is to measure how safe and effective dupilumab is in treating participants with BP who are off oral corticosteroids. Prior research studies in humans have shown that dupilumab may help control the immune system that is responsible for the signs and symptoms of BP and help achieve disease improvement.
Anticipated enrolment close date: Ongoing
Who can take part
Inclusion criteria
- Adults over the age of 18 and less than 90 with bullous pemphigoid
- Confirmation of diagnosis of bullous pemphigoid from skin biopsies and blood tests
Exclusion criteria
- Forms of other pemphigoid disease (for example, mucous membrane-dominant BP, Brunsting-Perry cicatrial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita and BP with concomitant pemphigus vulgaris)
- Evidence of active infection including TB or hepatitis
- Unstable medical and psychiatric conditions
What's involved
- Approximately 20 visits
- Skin checks
- Provide blood/urine samples
- ECG
- Skin biopsies
- Chest x-ray
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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