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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2027-10-31

Brief Summary

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

Detailed Description

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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

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Primary Membranous Nephropathy

Keywords

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PMN Anti-CD19 PrisMN

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183

Intervention Type DRUG

Other Intervention Names

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TNT119

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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Climb Bio Study Director

Role: CONTACT

Phone: +1 866 857 2596

Email: [email protected]

Other Identifiers

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TNT119-PMN-201

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Cohort 1: Dose Level A

budoprutug

Cohort 2: Dose Level B

budoprutug

Cohort 3: Dose Level C

budoprutug

Interventions

budoprutug

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Climb Bio, Inc.

Responsible Party

Locations

Climb Bio Investigative Site #110

Climb Bio Investigative Site #105

Climb Bio Investigative Site #108

Climb Bio Investigative Site #106

Climb Bio Investigative Site #101

Climb Bio Investigative Site #102

Climb Bio Investigative Site #103

Climb Bio Investigative Site #104

Climb Bio Investigative Site #803

Climb Bio Investigative Site# 801

Climb Bio Investigative Site #805

Climb Bio Investigative Site #804

Climb Bio Investigative Site #802

Countries

Central Contacts

Climb Bio Study Director

Other Identifiers

TNT119-PMN-201