Systemic lupus erythematosus (SLE) is a chronic autoimmune condition that can cause inflammation, flares and organ damage, even when people are receiving standard treatment. Many people continue to experience uncontrolled symptoms, frequent relapses and side effects from existing therapies.
This study is for adults with SLE, including people with moderate to severely active extra-renal SLE and people with Class III or IV lupus nephritis.
The study is evaluating the safety, tolerability and effects of an investigational treatment. The treatment is a first-in-human antibody designed to target B cells involved in lupus.
The investigational treatment is given by intravenous infusion and is being studied to see whether it may help reduce disease activity and improve long-term outcomes for people living with lupus.
You may be eligible if:
If eligible, you will take part in the study for approximately 13 months, including screening, treatment and follow-up. The screening period lasts up to 35 days and may take up to 6 hours.
Treatment is given at two infusion visits on Day 1 and Day 8. Each dosing visit lasts approximately 10 hours. There are also shorter check-in visits on Days 2, 4, 9, 11 and 14, each lasting about one hour.
On Day 29, you will return for a longer visit lasting approximately 3 hours. Follow-up visits then continue monthly for the first 6 months and every 3 months until Month 12. In total, there are approximately 16 clinic visits.
The investigational treatment is given by intravenous infusion into a vein in the arm during the two dosing visits. Throughout the study, health checks and assessments may include:
After each infusion visit, a caregiver or family member will need to stay with you for 24 hours to help ensure your safety.
Reimbursement for study-related time and travel will be provided.