eligibility_summary
Adults 18–65 with new or relapsing severe active AAV (GPA/MPA per 2022 ACR/EULAR), PR3-ANCA+. Excludes prior rituximab intolerance, other autoimmune disease, severe liver dysfunction/Child C, heart failure, ESRD (eGFR<30), pregnancy/planned <2 yrs, uncontrolled severe HTN/diabetes, active bacterial/fungal/hepatitis/mycobacterial infection, malignancy, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05962840 tests B‑cell–targeted therapy in ANCA‑associated vasculitis. Design: randomized, single‑blind, placebo‑controlled, single‑center Phase 4 in China. All patients receive rituximab plus glucocorticoids for remission induction, then telitacicept 80 mg SC weekly for 12 months vs placebo for maintenance. Drugs/mechanisms: 1) Rituximab—chimeric anti‑CD20 monoclonal antibody, depletes CD20+ B cells (pre‑B to mature), lowering precursors of ANCA‑producing cells. 2) Telitacicept—TACI‑Fc fusion protein, dual BAFF (BLyS)/APRIL inhibitor acting as a decoy receptor to block TNF‑family survival signals, reducing B‑cell maturation into plasmablasts/plasma cells and autoantibody production. Targets: B‑cell lineage (CD20+ B cells, plasmablast/plasma cell generation) and BAFF/APRIL–TACI pathways, aiming to reduce ANCA production and relapse.