A clinical trial to assess how safe and effective the study drug. efgartigimod, is in treating participants with pemphigus who are also receiving oral corticosteroids.
About this study
Pemphigus is a rare, autoimmune skin condition characterised by blistering and itchiness. Many patients who have pemphigus require treatment with topical steroids, tablets, injections or infusions.
The purpose of this research project is to measure how safe and effective efgartigimod is in treating participants with pemphigus also receiving oral corticosteroids. Efgartigimod is injected into the skin.
Prior research studies in humans have shown that efgartigimod may help control the immune system that is responsible for the signs and symptoms of pemphigus and help achieve disease improvement.
Who can take part
Inclusion criteria
- A diagnosis of pemphigus vulgaris or pemphigus foliaceous
- Be either newly diagnosed with or diagnosed within 4 years and having a flare of disease
Exclusion criteria
- Other forms of blistering skin conditions
- A previous reaction or contraindication to oral steroid medication
What's involved
- Chest x-ray, blood and urine samples, ECG, weight, blood pressure
- Weekly visit for at least first six-week then pending response option for at-home injection with monthly visit to site
- 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.