Last updated 33 days ago
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
45 patients around the world
Available in Chile, Argentina, United States, Brazil
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.
6Research sites
45Patients around the world
This study is for people with
Nephropathy
Primary membranous nephropathy
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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.
Sites
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
DOM Centro de Reumatología - CABA
Recruiting
Hospital El Cruce - Nestor Kirchner
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Clínica de Nefrología Urología y Enfermedades Cardiovasculares - Santa Fe
Recruiting
Clínica Privada Vélez Sarsfield - Córdoba
Recruiting
StudyPrisMN
SponsorClimb Bio, Inc.
Study typeInterventional
Conditions
Primary membranous nephropathy
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07096843
