The goal of the VIBRANT trial is to determine if treating lupus nephritis (LN) with VIB4920 in addition to standard therapy is more effective than treating LN with standard therapy alone.
About the Investigational Study Drug
VIB4920, also known as dazodilibep, is a bioengineered protein that works by blocking CD40L and preventing immune cells from attacking one’s own body, including the kidneys. VIB4920 was found to be safe, tolerable, and effective in an early phase trial in rheumatoid arthritis patients, and it is currently being used in other trials. VIB4920 is considered an experimental treatment because it has not been approved in the U.S. or elsewhere for use in any disease, including LN.
Participating in VIBRANT
Eligible participants will:
- Receive standard intravenous (IV) methylprednisolone and oral mycophenolate mofetil (MMF) therapy for LN.
- Take prednisone and rapidly decrease the dose during the first 8 weeks of the study.
- Be assigned to treatment with either VIB4920 (2/3 of participants) or placebo (1/3 of participants).
Participants assigned to treatment with VIB4920 or placebo will:
- Receive VIB4920 or placebo via IV at Weeks 0, 2, 4, 8, 12, 16, 20, and 24. There will also be a study visit without an infusion at Week 1.
- Continue to receive MMF and prednisone.
- Have a kidney biopsy between Weeks 36 and 48. The kidney biopsy is recommended but is not required. You and your study doctor will decide together if you will have this biopsy.
- Have follow-up study visits at Weeks 28, 32, 36, 48 and 60.
You cannot choose your group. A computer randomly picks who receives VIB4920 or placebo.