This early-phase study is testing a new treatment for adults with moderate to severe lupus (SLE). The new treatment is a type of antibody designed to help the immune system remove certain B cells that play a role in lupus.
The study will test how safe the medicine is, how it behaves in the body, and how it affects the immune system. Participants receive up to four injections under the skin and attend regular clinic visits and blood tests over about two years to monitor health and response to treatment.
Anticipated date close of enrolment: November 2026
Who can take part
- Adults aged 18 years and older with moderately to severely active lupus (SLE)
- No active infection or recent use of certain immunosuppressive drugs
- Not pregnant or breastfeeding and using effective contraception for 12 weeks after treatment
- Able to complete scheduled visits and monitoring over 12 months
What is involved for participants
- Screening tests (blood, urine, ECG, physical exam, SLE assessment)
- Subcutaneous (under-the-skin) injections of CLN-978 (up to 4 doses)
- Short hospital stays for monitoring after doses
- Regular clinic visits for vital signs, lab tests, and heart checks for about 1 year of follow-up
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.