Recruiting
Phase 2

Budoprutug

Sponsor:

Climb Bio, Inc.

Code:

NCT07096843

Conditions

Primary Membranous Nephropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

budoprutug

Study Details

Brief summary:

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

Conditions

Primary Membranous Nephropathy

Study ID

NCT07096843

Start date

Aug 25, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Dose Level A

experimental: Cohort 2: Dose Level B

experimental: Cohort 3: Dose Level C

Interventions

budoprutug

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

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 48 ]

Central Contacts and Locations

Central contacts

Climb Bio Study Director

+1 866 857 2596clinicaltrials@climbbio.com

Locations

Climb Bio Investigative Site #110

Recruiting

Denver, Colorado, United States, 80220

Climb Bio Investigative Site #105

Recruiting

Orlando, Florida, United States, 32086

Climb Bio Investigative Site #108

Recruiting

Atlanta, Georgia, United States, 30342

Climb Bio Investigative Site #106

Recruiting

Indianapolis, Indiana, United States, 46268

Climb Bio Investigative Site #101

Recruiting

Clifton Park, New York, United States, 12065

Climb Bio Investigative Site #104

Recruiting

Sherman, Texas, United States, 75092

More Information

Sponsor

Climb Bio, Inc.

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • PMN
  • Anti-CD19
  • PrisMN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Climb Bio, Inc. on 2026-07-16.