Clinical Research Studies

This is a Phase 2b, randomized, double-blind, placebo-controlled, global, multicenter study to evaluate efficacy and safety of zetomipzomib in patients with active Class III/IV +/-V LN or pure Class V. The study will enroll approximately 279 patients: 249 patients with biopsy-proven Class III/IV +/-V LN with urine protein to creatinine ratio (UPCR) =1.0 and up to 30 patients with pure Class V with UPCR =2.0. Zetomipzomib will be administered at a dose level of 30 mg or 60 mg (the latter following step-up from an initial Week 1 dose of 30 mg). For each dose group, patients will be randomized in a 2:1 ratio to receive either zetomipzomib or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up visit. Each treatment group (30 mg, 60 mg, or placebo) will include approximately 83 patients per group with Class III/IV +/-V and up to 10 per treatment group with pure Class V LN, for a total of up to 279 patients. During the treatment period, patients will also receive background standard of care therapy consisting of MMF or equivalent for 52 weeks plus corticosteroids tapered over 16 weeks.