Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Condition studied

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Incidence of TEAEs and TESAEs., Changes from Baseline in safety assessments (vital sign measurements, physical examination, clinical laboratory tests, and ECG results).

Endpoint detail

Achieving disease remission at Week 26., Achieving sustained remission at Week 52., Achieving BVAS = 0 at [CCI], 26, and 52., Relapse after previously achieving disease remission at Week 26., Time to first relapse after having achieved disease remission at Week 26., Change from Baseline in Vasculitis Damage Index (VDI) at [CCI] 26, and 52., Time to first occurrence of BVAS = 0., Change from Baseline in BVAS at all timepoints., Change from Baseline in eGFR (mL/min per 1.73 m2) at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UPCR (mg/g) and % change from Baseline at [CCI] 26, and 52., Change from Baseline in proteinuria based on spot UACR (mg/g) and % change from Baseline at [CCI] 26, and 52., Hematuria change from Baseline (RBCs/HPF) and % change from Baseline at [CCI] 26, and 52.