eligibility_summary
Eligible: PR3-ANCA-positive GPA/MPA (CHCC) with severe new/relapsing AAV (BVAS/WG >=3, relapses need detectable B cells) and COVID-19 spike Ab after vaccination/booster >=4 wks or prior infection, contraception required. Exclude: EGPA, MPO-ANCA+, non-severe AAV, active/recurrent serious infections (HBV/HCV/HIV/COVID), severe liver disease, anti-GBM, malignancy <5y, uncontrolled comorbidities, HACA, pregnancy/breastfeeding, prohibited meds, plasma exchange <3 mo, monoclonal intolerance, live vaccine <4 wks, daily NSAIDs, cytopenias or AST/ALT/amylase >2.5x ULN.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, randomized, double-blind, active-controlled study in PR3-ANCA–associated vasculitis (GPA/MPA). Interventions: obinutuzumab vs rituximab, each 1000 mg IV on days 1 and 15. Both are anti-CD20 monoclonal antibodies that deplete B cells. Obinutuzumab: humanized, glycoengineered, type II mAb with enhanced antibody-dependent cellular cytotoxicity (ADCC) and direct cell death, with less complement dependence. Rituximab: chimeric, type I mAb that relies on complement-dependent cytotoxicity (CDC) and ADCC. Targets/pathways: CD20+ pre-B and mature B cells to reduce PR3-ANCA production, thereby decreasing autoantibody-mediated neutrophil activation and small-vessel inflammation, impacts Fc-effector and complement pathways and B-cell receptor/activation signaling. Status: terminated (funding withdrawn).