A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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)
• Other inclusion criteria may apply
Locations
United States
Colorado
Climb Bio Investigative Site #110
RECRUITING
Denver
Florida
Climb Bio Investigative Site #105
RECRUITING
Orlando
Georgia
Climb Bio Investigative Site #108
RECRUITING
Atlanta
Indiana
Climb Bio Investigative Site #106
NOT_YET_RECRUITING
Indianapolis
Missouri
Climb Bio Investigative Site #109
NOT_YET_RECRUITING
City Of Saint Peters
New York
Climb Bio Investigative Site #101
RECRUITING
Clifton Park
Pennsylvania
Climb Bio Investigative Site #102
NOT_YET_RECRUITING
Philadelphia
Texas
Climb Bio Investigative Site #104
RECRUITING
Sherman
Other Locations
Ukraine
Climb Bio Investigative Site #803
NOT_YET_RECRUITING
Ivano-frankivsk
Climb Bio Investigative Site #805
NOT_YET_RECRUITING
Kyiv
Climb Bio Investigative Site# 801
NOT_YET_RECRUITING
Kyiv
Climb Bio Investigative Site #804
NOT_YET_RECRUITING
Rivne
Climb Bio Investigative Site #802
NOT_YET_RECRUITING
Ternopil
Contact Information
Primary
Climb Bio Study Director
clinicaltrials@climbbio.com
+1 866 857 2596
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2027-10
Participants
Target number of participants: 45
Treatments
Experimental: Cohort 1: Dose Level A
Experimental: Cohort 2: Dose Level B
Experimental: Cohort 3: Dose Level C
Related Therapeutic Areas
Sponsors
Leads: Climb Bio, Inc.