A Phase 2 interventional study of budoprutug in Primary Membranous Nephropathy, sponsored by Climb Bio, Inc.. Recruiting at 43 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Climb Bio, Inc. · Phase 2, Interventional, and Treatment
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
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.
Climb Bio, Inc. is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: budoprutug
Drug: budoprutug
Drug: budoprutug
Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
Also known as: TNT119
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Time frame: Up to Week 48
Change in total B Cell Count
Absolute and % change in total number of peripheral B cells over time.
Time frame: Up to Week 48
Change in Anti-PLA2R Antibodies
Change from Baseline in anti-PLA2R antibody titers over time.
Time frame: Up to Week 48
Complete Remission Rate
Proportion of subjects who achieve complete remission at Week 48.
Time frame: Week 48
Complete or Partial Remission Rate
Proportion of subjects who achieve complete or partial remission at Week 48.
Time frame: Week 48
Change in Proteinuria
Change from Baseline in proteinuria (measured via urine protein-creatinine ratio, UPCR) over time.
Time frame: Up to Week 48
Change in UACR
Change in urine albumin-to-creatinine ratio over time.
Time frame: Up to Week 48
Change in eGFR
Change from Baseline in eGFR over time.
Time frame: Up to Week 48
Area Under the Curve (AUC)
Measurement of the area under the drug concentration-time curve.
Time frame: Up to Week 48
Maximum Observed Plasma Concentration (Cmax)
Measurement of the maximum observed plasma concentration.
Time frame: Up to Week 48
Time to Maximum Observed Concentration (Tmax)
Measurement of the time to maximum observed concentration.
Time frame: Up to Week 48
Terminal Half-Life (T1/2)
Measurement of the terminal half-life in days.
Time frame: Up to Week 48
Apparent Clearance (CL/F)
Measurement of the apparent clearance in L/hour.
Time frame: Up to Week 48
Volume of Distribution (Vd)
Measurement of the volume of distribution in liters.
Time frame: Up to Week 48
Plan to share: No
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Climb Bio, Inc.