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

Last updated: July 14, 2026
Sponsor: Climb Bio, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Nephrotic Syndrome

Idiopathic Membranous Nephropathy

Glomerulonephritis

Treatment

budoprutug

Clinical Study ID

NCT07096843
TNT119-PMN-201
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of PMN with positive anti-PLA2R antibodies

  • CD19+ B cell count ≥40 cells/μL

  • UPCR ≥2.0 g/g

  • eGFR ≥35 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

Exclusion

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

  • Other exclusion criteria may apply

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: budoprutug
Phase: 2
Study Start date:
August 25, 2025
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • Climb Bio Investigative Site# 602

    Buenos Aires, B1629
    Argentina

    Active - Recruiting

  • Climb Bio Investigative Site# 603

    Buenos Aires, B1888
    Argentina

    Active - Recruiting

  • Climb Bio Investigative Site# 602

    Buenos Aires 3435910, B1629
    Argentina

    Active - Recruiting

  • Climb Bio Investigative Site #601

    CABA, C1111
    Argentina

    Active - Recruiting

  • Climb Bio Investigative Site #604

    CABA, C1425
    Argentina

    Active - Recruiting

  • Climb Bio Investigative Site #606

    Santa Fe, S3000
    Argentina

    Active - Recruiting

  • Climb Bio Investigative Site #502

    Belo Horizonte, 30150-320
    Brazil

    Active - Recruiting

  • Climb Bio Investigative Site #505

    Minas Gerais, 36010-570
    Brazil

    Active - Recruiting

  • Climb Bio Investigative Site #506

    Pernambuco, 50670-901
    Brazil

    Active - Recruiting

  • Climb Bio Investigative Site #501

    Porto Alegre, 90020-090
    Brazil

    Active - Recruiting

  • Climb Bio Investigative Site #503

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Climb Bio Investigative Site #504

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Climb Bio Investigative Site #503

    São Paulo 3448439, 05403-000
    Brazil

    Active - Recruiting

  • Climb Bio Investigative Site #701

    Temuco, Araucania 4811230
    Chile

    Site Not Available

  • Climb Bio Investigative Site #703

    Valdivia, Los Ríos Region 5020000
    Chile

    Site Not Available

  • Climb Bio Investigative Site #702

    Santiago, Santiago Metropolitan 8320165
    Chile

    Site Not Available

  • Climb Bio Investigative Site #403

    Beijing, Changping District 102218
    China

    Site Not Available

  • Climb Bio Investigative Site #401

    Beijing, Cheng District 100034
    China

    Active - Recruiting

  • Climb Bio Investigative Site #408

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • Climb Bio Investigative Site #402

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • Climb Bio Investigative Site #407

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Climb Bio Investigative Site #405

    Jinan, Shandong 250014
    China

    Site Not Available

  • Climb Bio Investigative Site #409

    Yantai, Shandong 264000
    China

    Site Not Available

  • Climb Bio Investigative Site #404

    Yibin, Sichuan 644000
    China

    Site Not Available

  • Climb Bio Investigative Site #406

    Beijing, Xicheng District 100044
    China

    Site Not Available

  • Climb Bio Investigative Site #901

    Tbilisi, 0144
    Georgia

    Active - Recruiting

  • Climb Bio Investigative Site #902

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • Climb Bio Investigative Site #903

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Climb Bio Investigative Site #901

    Tbilisi 611717, 0144
    Georgia

    Active - Recruiting

  • Climb Bio Investigative Site #902

    Tbilisi 611717, 0114
    Georgia

    Active - Recruiting

  • Climb Bio Investigative Site #204

    Taichung, 404
    Taiwan

    Active - Recruiting

  • Climb Bio Investigative Site #205

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Climb Bio Investigative Site# 201

    Taipei, 110
    Taiwan

    Active - Recruiting

  • Climb Bio Investigative Site# 202

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Climb Bio Investigative Site# 203

    Taipei, 235
    Taiwan

    Active - Recruiting

  • Climb Bio Investigative Site# 201

    Taipei 1668341, 110
    Taiwan

    Active - Recruiting

  • Climb Bio Investigative Site# 202

    Taipei 1668341, 100
    Taiwan

    Site Not Available

  • Climb Bio Investigative Site# 203

    Taipei 1668341, 235
    Taiwan

    Site Not Available

  • Climb Bio Investigative Site #803

    Ivano-Frankivsk, 76008
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #805

    Kyiv, 03151
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site# 801

    Kyiv, 02125
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #805

    Kyiv 703448, 03151
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #804

    Rivne, 33027
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #802

    Ternopil, 46002
    Ukraine

    Active - Recruiting

  • Climb Bio Investigative Site #110

    Denver, Colorado 80220
    United States

    Active - Recruiting

  • Climb Bio Investigative Site #105

    Orlando, Florida 32086
    United States

    Active - Recruiting

  • Climb Bio Investigative Site #108

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Climb Bio Investigative Site #106

    Indianapolis, Indiana 46268
    United States

    Active - Recruiting

  • Climb Bio Investigative Site #111

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Climb Bio Investigative Site #1092

    City of Saint Peters 4407237, Missouri 4398678 63376
    United States

    Site Not Available

  • Climb Bio Investigative Site #101

    Clifton Park, New York 12065
    United States

    Active - Recruiting

  • Climb Bio Investigative Site #104

    Sherman, Texas 75092
    United States

    Active - Recruiting

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