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Abstract
The goal of the VIBRANT trial is to determine if treating lupus nephritis with VIB4920 in addition to standard therapy is more effective than treating lupus nephritis with standard therapy alone.
About the Investigational Study Drug
VIB4920 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 for use in lupus nephritis or other diseases.
Participating in VIBRANT
Eligible participants will:
- Receive standard 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.
- Have study visits at Weeks 4 and 8. At Week 8, participants will be evaluated to see how well they are responding to treatment. Participants who have responded well to treatment will leave the study and return to their rheumatologist or nephrologist for ongoing treatment. Participants who have not responded well will 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 10, 12, 14, 18, 22, 26, 30, and 34. There will also be a study visit without an infusion at Week 11.
- Continue to receive MMF and prednisone.
- Have a kidney biopsy Week 38.
- Have follow-up study visits at Weeks 48 and 60.
About This Study
The goal of the VIBRANT trial is to determine if treating lupus nephritis with VIB4920 in addition to standard therapy is more effective than treating lupus nephritis with standard therapy alone.
Systemic Lupus Erythematosus (SLE)
SLE is an autoimmune disease that can affect many different organ systems. As many as 60% of adults with SLE develop lupus nephritis (LN) - a serious manifestation of SLE in which the immune system begins to attack the kidneys. As a result, the kidneys become inflamed and can’t function properly, which can significantly impair quality of life and may eventually lead to kidney failure.
Standard treatment for lupus nephritis involves initial treatment with a steroid medicine to reduce kidney inflammation combined with an immunosuppressive medication to stop the immune system from attacking the kidney. Maintenance therapy following the recovery of kidney function requires continued steroids and immunosuppressive medication for a minimum of 2 years, typically longer.
The U.S. Food and Drug Administration (FDA) recently approved two drugs for the treatment of lupus nephritis. All available treatments can result in side effects and their effectiveness in the short- and long-term vary for different people. Therefore, additional research is needed to find new treatments that have minimal side effects and are effective in producing long-term disease improvement.
About the Investigational Study Drug
VIB4920 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 for use in lupus nephritis or other diseases.
Participating in VIBRANT
Eligible participants will:
- Receive standard 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.
- Have study visits at Weeks 4 and 8. At Week 8, participants will be evaluated to see how well they are responding to treatment. Participants who have responded well to treatment will leave the study and return to their rheumatologist or nephrologist for ongoing treatment. Participants who have not responded well will 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 10, 12, 14, 18, 22, 26, 30, and 34. There will also be a study visit without an infusion at Week 11.
- Continue to receive MMF and prednisone.
- Have a kidney biopsy Week 38.
- Have follow-up study visits at Weeks 48 and 60.
You cannot choose your group. A computer randomly picks who receives the study drug.
Do you Qualify for this Clinical Trial?
You may be eligible to participate in the VIBRANT Study if you:
- Are 18 years or older
- Have been diagnosed with Systemic Lupus Erythematosus
- Have active lupus nephritis based on the amount of protein in your urine and the results of your kidney biopsy at the screening visit.