Lupus Nephritis Clinical Trial
Official title:
A Phase 2a Randomized Placebo-Controlled Double-Blind Multicenter Trial of VIB4920 for Active Lupus Nephritis (ITN091AI)
This is a multi-center double-blind placebo controlled clinical trial evaluating the efficacy of VIB4920 combined with mycophenolate mofetil (MMF) and prednisone in achieving a renal response in participants with active lupus nephritis (LN).
Up to 114 eligible participants with active lupus nephritis (LN) will receive induction therapy with mycophenolate mofetil (MMF) and methylprednisolone beginning at Week 0.Participants will also receive prednisone 25 mg per day beginning at Week 0 and tapered to 5 mg per day at Week 8. Participants will be assessed at Week 8 for a renal response. Sixty-six participants with a urine protein-to-creatinine ratio (UPCR) > 0.75 will be randomized 2:1 to receive VIB4920 versus placebo at Week 10. Participants who are not eligible for randomization will complete study participation after the Week 8 study visit, and further care will be provided according to the judgment of the site investigator or treating physician. Randomized participants will receive VIB4920 1500 mg or placebo intravenously at Weeks 10, 12, 14, 18, 22, 26, 30, and 34, and will continue MMF 2-3 g per day and prednisone 5 mg per day. The primary endpoint will be assessed at Week 38, and participants followed until Week 60. ;
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