A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease

Condition studied

Antibody-mediated Kidney Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

• Incidence and severity of AEs, SAEs, and AESIs • AEs/SAEs leading to discontinuation of surovatamig • Vital signs • Physical examination • Laboratory parameters • 12-lead ECG, Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) at 6 months.

Endpoint detail

Percentage of participants achieving complete or partial remission of pMN at 24 months −Complete remission: reduction of proteinuria from baseline to a value ≤ XX g/24 h plus stable kidney function −Partial remission: reduction of proteinuria > XX from baseline and a value < XX g/24 h plus stable kidney function. Note: A stable kidney function is defined as a GFR that remains unchanged or declines by < XX., Percentage of participants achieving complete remission of pMN at 24 months. Percentage of participants achieving partial remission of pMN at 24 months., Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) to 24 months, Change from baseline in anti-PLA2R antibody titer to 24 months, Change from baseline in B-cell count in peripheral blood to 24 months, Time to relapse after complete or partial remission up to 24 months, Time to a ≥ 3 months sustained reduction of eGFR ≥ XX from baseline up to 24 months, Change from baseline in Patient Reported Outcome, Serum PK parameters of surovatamig, including but not limited to AUC and Cmax, Treatment-emergent ADAs