A clinical trial to assess the effectiveness of enpatoran in lupus.
About this study
Lupus is an autoimmune condition that causes the body’s immune system to attack its own cells which in turn causes inflammation and tissue damage.
This trial investigates the effectiveness and safety of a drug called enpatoran. Enpatoran is an oral medication designed to block specific cell pathways that cause the immune system to recognise the body as foreign and attack.
In this trial, you will enter one of four groups:
- Three of these groups will receive a varying dose of the trial medication
- One of these groups will receive a placebo
The trial runs over 33 weeks, with monthly visits to the Clinical Trials Centre.
Anticipated enrolment close date: Ongoing
Contact the Dermatology Research Team for more information.
Who can take part
To participate you must:
- Be 18 years of age and below 75 years old with a confirmed diagnosis of lupus for more than 6 months
- Have a diagnosis of lupus from a medical specialist
- Be currently receiving a stable dose of at least one of the following for your lupus - immunosuppressant, oral corticosteroids or topical steroids
You will not be able to participate if:
- You have any other autoimmune disease, skin condition, infectious disease or uncontrolled disease that may interfere with study assessments
- Your lupus is caused by a medication
- You have medical issues involving your heart, kidneys or brain
- You have a history of cancer
What's involved
- 33-week trial with 24 weeks of active treatment
- Twice daily administration of oral medication
- Skin photography and skin biopsy
- Blood samples
- Blood pressure, weight, and physical examination
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.