Phase 2 Study Evaluates Frexalimab, Brivekimig, Rilzabrutinib in FSGS and MCD

Status: RECRUITING | Phase: PHASE2 Condition(s): Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion Intervention(s): frexalimab (DRUG), brivekimig (DRUG), rilzabrutinib (DRUG), placebo (DRUG) This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits. Primary Outcome(s): Percent reduction in urine protein to creatinine ratio (UPCR) Enrollment: 84 (ESTIMATED) Lead Sponsor: Sanofi Start: 2024-12-19 | Primary Completion: 2026-12-23