Study of NM8074 in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)

Exclusion Criteria

• •Severe disease as determined by alveolar hemorrhage, hemoptysis, rapid onset mononeuritis multiplex or central nervous system involvement.
• •Patients with rapidly progressive glomerulonephritis
• •Any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (EGPA, Churg Strauss), systemic lupus erythematosus, Immunoglobulin A (lgA) vasculitis (HenochSchönlein purpura), rheumatoid vasculitis, Sjogren's disease, anti
• •glomerular basement membrane disease, or cryoglobulinemia.
• •Required dialysis or plasma exchange within 12 weeks prior to screening.
• •Have a kidney transplant or disease.
• •Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1.
• •Received intravenous glucocorticoids, \>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening.
• •Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
• •Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., Cluster of Differentiation 19 (CD19) count \> 0.01x10\^9/L); received anti-tumor necrosis factor (TNF) treatment or other complement inhibitor treatment within 12 weeks prior to screening.
• •Currently or previously under other complement inhibitor treatments less than 3 months prior to study Day 1.
• •Patients who need the initiation of renal replacement therapy within 7 days
• •Have any other clinically significant abnormal laboratory value in the opinion of the investigator.
• •History of bone marrow, hematopoietic stem cell, or solid organ transplantation.
• •History of currently active primary or secondary immunodeficiency.
• •Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections.
• •Pregnant, planning to become pregnant, or nursing female subjects.
• •Females who have a positive pregnancy test result at Screening or on Day 1.