NCT07096843

A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Climb Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN

Detailed 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.

Conditions

• Primary Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	budoprutug	Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183

Timeline

• Start date: 2025-08-25
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-07-31
• Last updated: 2026-04-17

Locations

33 sites across 6 countries: United States, Argentina, Brazil, Georgia, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study