Primary Membranous NephropathyPhase 2PrisMNNCT07096843
A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy
A Phase 2 study testing budoprutug in people with Primary Membranous Nephropathy, run by Climb Bio, Inc. at 38 sites in 7 countries.
Trial summary
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- budoprutug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 38 sitesin 7 countries
- Study dates
- 25 Aug 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Adequate hematologic, hepatic, and renal function
- Willing to use effective contraception (both sexes)
- Other inclusion criteria may apply
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or breastfeeding
- Recent major surgery or hospitalization
- Other exclusion criteria may apply
Trial locations and contacts
38 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 7 countries
China8 sites, 8 recruiting
- Not yet recruiting
Climb Bio Investigative Site #403
Beijing, Changping District, 102218
- Recruiting
Climb Bio Investigative Site #401
Beijing, Cheng District, 100034
- Recruiting
Climb Bio Investigative Site #406
Beijing, Xicheng District, 100044
- Not yet recruiting
Climb Bio Investigative Site #405
Jinan, Shandong, 250014
- Not yet recruiting
Climb Bio Investigative Site #408
Shenzhen, Guangdong, 518036
- Recruiting
Climb Bio Investigative Site #402
Wuxi, Jiangsu, 214023
- Recruiting
Climb Bio Investigative Site #409
Yantai, Shandong, 264000
- Recruiting
Climb Bio Investigative Site #404
Yibin, Sichuan, 644000
United States6 sites, 6 recruiting
- Recruiting
Climb Bio Investigative Site #108
Atlanta, Georgia, 30342
- Recruiting
Climb Bio Investigative Site #101
Clifton Park, New York, 12065
- Recruiting
Climb Bio Investigative Site #110
Denver, Colorado, 80220
- Recruiting
Climb Bio Investigative Site #106
Indianapolis, Indiana, 46268
- Recruiting
Climb Bio Investigative Site #105
Orlando, Florida, 32086
- Recruiting
Climb Bio Investigative Site #104
Sherman, Texas, 75092
Brazil6 sites, 6 recruiting
- Recruiting
Climb Bio Investigative Site #502
Belo Horizonte, 30150-320
- Recruiting
Climb Bio Investigative Site #505
Minas Gerais, 36010-570
- Recruiting
Climb Bio Investigative Site #506
Pernambuco, 50670-901
- Recruiting
Climb Bio Investigative Site #501
Porto Alegre, 90020-090
- Recruiting
Climb Bio Investigative Site #503
São Paulo, 05403-000
- Recruiting
Climb Bio Investigative Site #504
São Paulo, 05403-000
Argentina5 sites, 5 recruiting
- Recruiting
Climb Bio Investigative Site# 602
Buenos Aires, B1629
- Recruiting
Climb Bio Investigative Site# 603
Buenos Aires, B1888
- Recruiting
Climb Bio Investigative Site #601
CABA, C1111
- Recruiting
Climb Bio Investigative Site #604
CABA, C1425
- Recruiting
Climb Bio Investigative Site #606
Santa Fe, S3000
Taiwan5 sites, 5 recruiting
- Recruiting
Climb Bio Investigative Site #204
Taichung, 404
- Recruiting
Climb Bio Investigative Site# 202
Taipei, 100
- Recruiting
Climb Bio Investigative Site# 201
Taipei, 110
- Recruiting
Climb Bio Investigative Site #205
Taipei, 112
- Recruiting
Climb Bio Investigative Site# 203
Taipei, 235
Ukraine5 sites, 5 recruiting
- Recruiting
Climb Bio Investigative Site #803
Ivano-Frankivsk, 76008
- Recruiting
Climb Bio Investigative Site# 801
Kyiv, 02125
- Recruiting
Climb Bio Investigative Site #805
Kyiv, 03151
- Recruiting
Climb Bio Investigative Site #804
Rivne, 33027
- Recruiting
Climb Bio Investigative Site #802
Ternopil, 46002
Georgia3 sites, 3 recruiting
- Recruiting
Climb Bio Investigative Site #903
Tbilisi, 0112
- Recruiting
Climb Bio Investigative Site #902
Tbilisi, 0114
- Recruiting
Climb Bio Investigative Site #901
Tbilisi, 0144
About this study
Official title: A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Read the detailed 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.
- Conditions
- Primary Membranous Nephropathy
- Being tested
- budoprutug
- Keywords
- PMN, Anti-CD19, PrisMN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budoprutugDrug
Also called TNT119
Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose Level A | Experimental | Not described Receives: Drug: budoprutug |
| Cohort 2: Dose Level B | Experimental | Not described Receives: Drug: budoprutug |
| Cohort 3: Dose Level C | Experimental | Not described Receives: Drug: budoprutug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Measured: Up to Week 48
Secondary outcomes (13)
Change in total B Cell Count
Absolute and % change in total number of peripheral B cells over time.
Measured: Up to Week 48
Change in Anti-PLA2R Antibodies
Change from Baseline in anti-PLA2R antibody titers over time.
Measured: Up to Week 48
Complete Remission Rate
Proportion of subjects who achieve complete remission at Week 48.
Measured: Week 48
Complete or Partial Remission Rate
Proportion of subjects who achieve complete or partial remission at Week 48.
Measured: Week 48
Change in Proteinuria
Change from Baseline in proteinuria (measured via urine protein-creatinine ratio, UPCR) over time.
Measured: Up to Week 48
Change in UACR
Change in urine albumin-to-creatinine ratio over time.
Measured: Up to Week 48
Change in eGFR
Change from Baseline in eGFR over time.
Measured: Up to Week 48
Area Under the Curve (AUC)
Measurement of the area under the drug concentration-time curve.
Measured: Up to Week 48
Maximum Observed Plasma Concentration (Cmax)
Measurement of the maximum observed plasma concentration.
Measured: Up to Week 48
Time to Maximum Observed Concentration (Tmax)
Measurement of the time to maximum observed concentration.
Measured: Up to Week 48
Terminal Half-Life (T1/2)
Measurement of the terminal half-life in days.
Measured: Up to Week 48
Apparent Clearance (CL/F)
Measurement of the apparent clearance in L/hour.
Measured: Up to Week 48
Volume of Distribution (Vd)
Measurement of the volume of distribution in liters.
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start25 Aug 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Climb Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096843
- Sponsor's protocol ID
- TNT119-PMN-201
- Acronym
- PrisMN
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
- ClinicalTrials.gov ID
- NCT07096843
- Acronym / sponsor ID
- PrisMN / TNT119-PMN-201
- Conditions
- Primary Membranous Nephropathy
- Keywords
- PMN, Anti-CD19, PrisMN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Climb Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose Level A | Experimental | Drug: budoprutug |
| Cohort 2: Dose Level B | Experimental | Drug: budoprutug |
| Cohort 3: Dose Level C | Experimental | Drug: budoprutug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budoprutugAlso: TNT119Single IV dose of study product on Day 1, Day 15, Day 169 and Day 183 | Drug | Cohort 1: Dose Level A, Cohort 2: Dose Level B, Cohort 3: Dose Level C |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 48
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
13 secondary outcomes
Change in total B Cell Count
Time frame: Up to Week 48
Change in Anti-PLA2R Antibodies
Time frame: Up to Week 48
Complete Remission Rate
Time frame: Week 48
Complete or Partial Remission Rate
Time frame: Week 48
Change in Proteinuria
Time frame: Up to Week 48
Change in UACR
Time frame: Up to Week 48
Change in eGFR
Time frame: Up to Week 48
Area Under the Curve (AUC)
Time frame: Up to Week 48
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Week 48
Time to Maximum Observed Concentration (Tmax)
Time frame: Up to Week 48
Terminal Half-Life (T1/2)
Time frame: Up to Week 48
Apparent Clearance (CL/F)
Time frame: Up to Week 48
Volume of Distribution (Vd)
Time frame: Up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
38 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing budoprutug in people with Primary Membranous Nephropathy, run by Climb Bio, Inc. at 38 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China, United States, Brazil, Argentina, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Climb Bio Study Director (+1 866 857 2596, clinicaltrials@climbbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.