Budoprutug for Membranous Nephropathy

(PrisMN Trial)

Recruiting at 37 trial locations

Overseen By Climb Bio Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Climb Bio, Inc.

Must be taking: RAAS inhibitors

Must not be taking: Immunosuppressants

Disqualifiers: Secondary membranous nephropathy, malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called budoprutug for individuals with primary membranous nephropathy (PMN), a kidney condition. Researchers aim to determine the safety and tolerability of the treatment at three different dose levels. Suitable participants have PMN, a specific type of antibody, and stable kidney function. This trial is significant for those interested in new treatment options for their condition. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important advancements in PMN treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should have stable RAAS inhibitor therapy, which suggests you may need to continue that specific medication.

Is there any evidence suggesting that budoprutug is likely to be safe for humans?

Research has shown that budoprutug has undergone safety testing in earlier studies. One study focused on assessing the drug's safety, and patients generally tolerated the treatment well. No serious side effects were directly linked to budoprutug. However, as with any medication, some side effects could occur, though none were severe in previous trials.

Since the current trial is in a later phase, budoprutug has passed initial safety checks. This indicates the drug is safe enough for further testing, but participants should remain aware of possible side effects. It is important to discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for membranous nephropathy?

Unlike traditional treatments for membranous nephropathy, which often involve immunosuppressants like corticosteroids or calcineurin inhibitors, Budoprutug presents a novel approach. Budoprutug is unique because it targets specific pathways in the immune system, aiming to reduce inflammation and proteinuria more precisely without broadly suppressing the immune response. Researchers are excited about Budoprutug because it has the potential to offer a more targeted treatment with fewer side effects, improving the quality of life for patients with this kidney condition. Additionally, Budoprutug's unique mechanism of action might address the underlying causes of the disease more effectively, offering hope for better long-term outcomes.

What evidence suggests that budoprutug might be an effective treatment for membranous nephropathy?

Research has shown that budoprutug might help treat membranous nephropathy, a kidney disorder. Early clinical data suggest that budoprutug can significantly reduce certain immune cells, quickly lower harmful proteins that attack the body, and even lead to recovery in some patients. In one study, by Week 48, three patients fully recovered, and two showed partial improvement. These findings suggest that budoprutug could effectively manage this kidney condition. Participants in this trial will join one of the various treatment arms, each testing different dose levels of budoprutug. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with Primary Membranous Nephropathy (PMN), a kidney condition. Participants must have certain levels of kidney function, blood pressure control, and B cell counts. They should be on stable RAAS inhibitor therapy and not pregnant or breastfeeding. Those with secondary PMN, recent major surgeries, high-risk infections, cancer history, or recent immunosuppressant use are excluded.

Inclusion Criteria

Willing to use effective contraception (both sexes)

My blood, liver, and kidney functions are all within normal ranges.

My RAAS inhibitor medication dose has been stable.

Exclusion Criteria

Pregnancy or breastfeeding

Other exclusion criteria may apply

I have been diagnosed with Secondary Membranous Nephropathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three intravenous dose regimens of budoprutug on Day 1, Day 15, Day 169, and Day 183

26 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with extended follow-up for B-cell recovery as needed

22 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Budoprutug

Trial Overview

The study tests the safety of three different doses of Budoprutug in treating PMN. It aims to see how well patients tolerate this medication by monitoring them closely over time while they receive one of the dose regimens.

How Is the Trial Designed?

Group I: Cohort 3: Dose Level C Experimental Treatment 1 Intervention

Group II: Cohort 2: Dose Level B Experimental Treatment 1 Intervention

Group III: Cohort 1: Dose Level A Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Climb Bio, Inc.

Lead Sponsor

Citations

1.

ir.climbbio.com

ir.climbbio.com/news-releases/news-release-details/climb-bio-reports-third-quarter-2025-financial-results-and

Climb Bio Reports Third Quarter 2025 Financial Results ...

Data from this trial is expected to provide insights into budoprutug activity after a single intravenous dose and will also help to inform ...

2.

eliemtx.gcs-web.com

eliemtx.gcs-web.com/news-releases/news-release-details/climb-bio-present-data-american-society-nephrology-asn-kidney

Climb Bio to Present Data at American Society of Nephrology ...

Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in pMN. A ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07096843

NCT07096843 | A Phase 2 Study of Budoprutug in ...

This Phase 2, open-label, multicenter study evaluates the safety, pharmacodynamics, and preliminary efficacy of three intravenous dose regimens of budoprutug in ...

4.

journals.lww.com

journals.lww.com/10.1681/ASN.202508cztpa9

Journal of the American Society of Nephrology

By Week 48, 3 patients achieved CR and 2 achieved partial remission (Cortazar et al, ASN 2024). Here we report the long-term outcomes up to 3 years post initial ...

5.

globenewswire.com

globenewswire.com/de/news-release/2025/11/06/3182420/0/en/climb-bio-reports-third-quarter-2025-financial-results-and-provides-business-updates.html

Climb Bio Reports Third Quarter 2025 Financial Results and

Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in pMN. A ...

6.

ir.eliemtx.com

ir.eliemtx.com/news-releases/news-release-details/climb-bio-reports-third-quarter-2025-financial-results-and

Climb Bio Reports Third Quarter 2025 Financial Results ...

Climb Bio is evaluating budoprutug in multiple clinical trials across three lead indications—primary membranous nephropathy (pMN), immune ...

7.

ir.climbbio.com

ir.climbbio.com/node/8451/pdf

Climb Bio Reports Second Quarter 2025 Financial Results ...

Climb Bio plans to evaluate budoprutug in multiple clinical trials across three lead indications—primary membranous nephropathy (pMN), immune.

8.

journals.lww.com

journals.lww.com/jasn/fulltext/2024/10001/a_phase_1b,_single_arm,_open_label_study_of.911.aspx

A Phase 1b, Single-Arm, Open-Label Study of Budoprutug, ...

The primary objective was safety. Secondary objectives included B-cell levels, anti-phospholipase A2 receptor (anti-PLA2R) antibody (Ab) levels, and changes in ...