Overview
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Description
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity (ADCC). This Phase 2, open-label, multicenter study evaluates the safety, pharmacodynamics, and preliminary efficacy of three intravenous dose regimens of budoprutug in adult subjects with primary membranous nephropathy (PMN) who are anti-PLA2R antibody positive and have persistent proteinuria despite optimized RAAS inhibition. Approximately 45 subjects will be enrolled across three sequential dose cohorts, each receiving a single IV dose of budoprutug on Day 1, Day 15, Day 169 and Day 183. Subjects will be followed through Week 48, with extended follow-up for B-cell recovery as needed.
Eligibility
Inclusion Criteria:
- Confirmed diagnosis of PMN with positive anti-PLA2R antibodies
- CD19+ B cell count ≥40 cells/μL
- UPCR ≥2.0 g/g
- eGFR ≥40 mL/min/1.73 m²
- Stable RAAS inhibitor therapy
- Blood pressure <150/90 mmHg at baseline
- Adequate hematologic, hepatic, and renal function
- Willing to use effective contraception (both sexes)
- Other inclusion criteria may apply
Exclusion Criteria:
- Secondary Membranous Nephropathy
- Rapidly progressive glomerulonephritis or other glomerulopathies
- Prior B cell-depleting therapy within 24 weeks
- Recent use of immunosuppressants
- Active or high-risk infections
- History of malignancy
- Pregnancy or breastfeeding
- Recent major surgery or hospitalization
- Other exclusion criteria may apply