Clinical Research Directory

Key Inclusion Criteria 1. Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher. 2. Participant must have a new diagnosis or a relapse of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), specifically granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). 3. Participant must have evidence of ANCA antibodies (anti-myeloperoxidase \[MPO\] or anti-proteinase 3 \[PR3\]) associated with AAV. 4. Participant must have active AAV with new or worsening signs or symptoms documented, as demonstrated by established disease activity criteria. Key Exclusion Criteria 1. Participant must not require advanced organ support for severe disease at screening. 2. Participant must not have a life-threatening illness requiring intensive care at screening. 3. Participant must not have another autoimmune disease that could affect evaluation of the study treatment, such as eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus (lupus), IgA vasculitis, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane (anti-GBM) disease, cryoglobulinemic vasculitis, or suspected drug-induced AAV. 4. Participant must not have received certain immune-modifying treatments within 6 months before screening, including avacopan, B-cell-targeted therapies, chimeric antigen receptor T-cell (CAR-T) cell therapies, belimumab, tocilizumab, or similar biologic therapies that affect the immune system. 5. Participant must not be receiving azathioprine, mycophenolate mofetil, or methotrexate unless they are willing and able to stop these medications before starting study treatment. 6. Participant must not have received rituximab, cyclophosphamide, or another B-cell-depleting therapy within 6 months before screening, except when rituximab or cyclophosphamide was administered as part of standard-of-care treatment.