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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Climb Bio Investigative Site #110
Denver, Colorado, United States
RECRUITINGClimb Bio Investigative Site #105
Orlando, Florida, United States
RECRUITINGClimb Bio Investigative Site #108
Atlanta, Georgia, United States
RECRUITINGClimb Bio Investigative Site #106
Indianapolis, Indiana, United States
RECRUITINGClimb Bio Investigative Site #101
Clifton Park, New York, United States
RECRUITINGClimb Bio Investigative Site #102
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGClimb Bio Investigative Site #103
El Paso, Texas, United States
RECRUITINGClimb Bio Investigative Site #104
Sherman, Texas, United States
RECRUITINGClimb Bio Investigative Site# 602
Buenos Aires, Argentina
RECRUITINGClimb Bio Investigative Site# 603
Buenos Aires, Argentina
RECRUITING...and 23 more locations
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