eligibility_summary
Adults (≥18) with newly diagnosed ANCA‑associated vasculitis (GPA/MPA) per 2012 CHCC and 2022 EULAR/ACR, PR3‑ or MPO‑ANCA positive, consent required. Exclude prior AAV therapy, severe renal (eGFR<15) or alveolar hemorrhage (O2>2 L/min), other multisystem autoimmune disease, HIV/HBV/HCV, pregnancy/lactation, malignancy ≤5y, active/recent TB, severe mAb allergy, need for systemic immunosuppression, B‑cell depletion ≤6 mo, prior avacopan, unable to take oral drugs, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 4, open-label, parallel, non-inferiority in newly diagnosed ANCA-associated vasculitis (MPA/GPA). Interventions: 1) Avacopan (oral small-molecule C5a receptor 1 [C5aR1/CD88] antagonist) + short-term reduced-dose prednisolone + rituximab induction, avacopan continued for maintenance. 2) Reduced-dose prednisolone + rituximab induction with scheduled rituximab maintenance. Mechanisms: Avacopan blocks complement C5a–C5aR1 signaling to limit neutrophil activation/chemotaxis and vascular injury. Rituximab (anti-CD20 monoclonal antibody) depletes B cells, reducing ANCA production. Prednisolone (glucocorticoid) broadly suppresses inflammatory gene transcription (e.g., NF-κB/AP-1), cytokines, and leukocyte trafficking. Targets: complement pathway (C5a/C5aR1), neutrophils, CD20+ B cells, and broader innate/adaptive immune pathways. Primary endpoint: remission at 26 weeks.