A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
- Registration Number
- NCT07096843
- Lead Sponsor
- Climb Bio, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1: Dose Level A budoprutug - Cohort 2: Dose Level B budoprutug - Cohort 3: Dose Level C budoprutug -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (TEAEs) Up to Week 48 Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
- Secondary Outcome Measures
Name Time Method Change in total B Cell Count Up to Week 48 Absolute and % change in total number of peripheral B cells over time.
Change in Anti-PLA2R Antibodies Up to Week 48 Change from Baseline in anti-PLA2R antibody titers over time.
Complete Remission Rate Week 48 Proportion of subjects who achieve complete remission at Week 48.
Complete or Partial Remission Rate Week 48 Proportion of subjects who achieve complete or partial remission at Week 48.
Change in Proteinuria Up to Week 48 Change from Baseline in proteinuria (measured via urine protein-creatinine ratio, UPCR) over time.
Change in UACR Up to Week 48 Change in urine albumin-to-creatinine ratio over time.
Change in eGFR Up to Week 48 Change from Baseline in eGFR over time.
Area Under the Curve (AUC) Up to Week 48 Measurement of the area under the drug concentration-time curve.
Maximum Observed Plasma Concentration (Cmax) Up to Week 48 Measurement of the maximum observed plasma concentration.
Time to Maximum Observed Concentration (Tmax) Up to Week 48 Measurement of the time to maximum observed concentration.
Terminal Half-Life (T1/2) Up to Week 48 Measurement of the terminal half-life in days.
Apparent Clearance (CL/F) Up to Week 48 Measurement of the apparent clearance in L/hour.
Volume of Distribution (Vd) Up to Week 48 Measurement of the volume of distribution in liters.
Trial Locations
- Locations (13)
Climb Bio Investigative Site #110
🇺🇸Denver, Colorado, United States
Climb Bio Investigative Site #105
🇺🇸Orlando, Florida, United States
Climb Bio Investigative Site #108
🇺🇸Atlanta, Georgia, United States
Climb Bio Investigative Site #106
🇺🇸Indianapolis, Indiana, United States
Climb Bio Investigative Site #101
🇺🇸Clifton Park, New York, United States
Climb Bio Investigative Site #102
🇺🇸Philadelphia, Pennsylvania, United States
Climb Bio Investigative Site #103
🇺🇸El Paso, Texas, United States
Climb Bio Investigative Site #104
🇺🇸Sherman, Texas, United States
Climb Bio Investigative Site #803
🇺🇦Ivano-Frankivsk, Ukraine
Climb Bio Investigative Site# 801
🇺🇦Kyiv, Ukraine
Scroll for more (3 remaining)Climb Bio Investigative Site #110🇺🇸Denver, Colorado, United States