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Recruiting Phase 2 NCT07096843

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

Trial Parameters

Condition Primary Membranous Nephropathy
Sponsor Climb Bio, Inc.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 45
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-08-25
Completion 2027-10
Interventions
budoprutug

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 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

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