This study aims to understand how effective and safe remibrutinib is for people with hidradenitis suppurativa (HS), how remibrutinib affects their daily lives, and helps to improve their overall health and wellbeing.
About this study
The research study is testing a new treatment called remibrutinib (LOU064). Designed specifically for individuals diagnosed with moderate to severe hidradenitis suppurativa (HS). This study aims to establish the efficacy and safety of remibrutinib Dose A and Dose B compared to placebo in participants with moderate to HS.
Remibrutinib is a selective inhibitor of specific proteins of cells called BTK, which are involved in the signalling pathways of B cells in the immune system. Inhibiting BTK can modulate the immune response, which is beneficial in autoimmune diseases where the immune system is attacking the body's own tissues, such as in HS. This study tests two doses of remibrutinib and uses a placebo control group to assess the treatment effects in an unbiased manner. A placebo is a medication with no active ingredients. It is given to a participant just like the study treatment is given but does not have any effect. We need to have a placebo in this study to compare it against the study treatment and to evaluate if the drug works and is safe.
The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks).
Anticipated enrolment close date: 07 May 2027
Who can take part
Who is eligible to participate?
- Aged 18 years or older with a diagnosis of HS based on clinical history and physical examination for at least 6 months
- No history of significant bleeding or coagulation disorders
- No history of current liver disease
Please note, other eligibility criteria may apply.
What's involved
- Attending the RMH approximately 17 times over a year and a half. Most study visits could take approximately up to 2.5 hours. However, your first visit may be longer and could take approximately 4 hours.
- Taking medication tablets twice a day
- Completing questionnaires and skin exams
- Safety blood tests & ECG
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.