eligibility_summary
Eligible: newly diagnosed or relapsed GPA or MPA (2022 ACR/EULAR), needing rituximab + glucocorticoids, BVAS ≥1 major, ≥3 minor, or ≥2 renal items, PR3 or MPO antibody positive now or previously documented. Exclude: other primary systemic diseases (e.g., EGPA, moderate-severe SLE, IgA vasculitis, rheumatoid vasculitis, Sjogrens, anti-GBM, cryoglobulinemic vasculitis, AIHA, ALPS, MCTD), alveolar hemorrhage needing invasive ventilation, eGFR <15 or renal replacement/transplant, plasma exchange/pheresis <12 weeks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Iptacopan (LNP023), an oral small‑molecule selective factor B inhibitor that blocks the alternative complement pathway C3 convertase, reducing C3a/C5a and membrane attack complex, placebo comparator. Both arms receive rituximab, an anti‑CD20 monoclonal antibody (B‑cell–depleting) as induction, glucocorticoids per SOC may be used. Targets/pathways: alternative complement pathway (via factor B → C3/C5 activation), dampening C5a‑driven neutrophil priming/activation and endothelial injury, CD20+ B cells to reduce ANCA (PR3/MPO) autoantibody production, downstream effects on neutrophils/monocytes and renal inflammation. Objective: induce and maintain remission in GPA/MPA ANCA‑associated vasculitis.