Clinical Research Directory

Inclusion Criteria: * Male or non-pregnant, non-lactating female ≥18 years of age (no maximum age). * Diagnosis of wAIHA at least 3 months prior to screening with a direct antiglobulin test (DAT) ≥1 positive for immunoglobulin G (IgG)±C3, or a diagnosis of mixed autoimmune hemolytic anemia (AIHA) that is DAT positive for both IgG and C3, with a presence of a cold antibody with a thermal amplitude ≥30ºCelcius. * Hemoglobin (Hgb) level ≤10.0 grams/deciliter (pre-transfusion). * Evidence of classical complement pathway activation. * Evidence of active hemolysis. * Stable use of glucocorticoids and immunosuppressants are permitted. * Vaccinations against encapsulated bacterial organisms within 5 years prior to screening or participant must be willing to receive prophylaxis against infections with encapsulated bacteria via vaccination and/or the use of prophylactic antibiotics in accordance with local standards of practice and/or guidelines. Exclusion Criteria: * Elevated aspartate aminotransferase or alanine aminotransferase levels \>2.5 times the upper limit of normal. * Platelet count \<30 X 10\^9/liter. * History of cold agglutinin disease. * History of solid organ, bone marrow, or stem cell transplantation. * History of splenectomy within the 3 months prior to screening. * Received rituximab or other anti-CD20 monoclonal antibody \<3 months prior to screening. * Intravenous immunoglobulin (IVIg) treatment within 3 months prior to screening or plasmapheresis or immunoadsorption treatment within 60 days prior to screening. * Clinically significant, recent, or ongoing illness or medical condition, including coexistent autoimmune disorder, malignancy, HIV, hepatitis B virus, and hepatitis C virus. * History of meningitis or septicemia within the past 2 years. * Treatment with an investigational therapeutic agent within 30 days prior to screening. * Hypersensitivity to any drug product or excipients used in this study or to previous IV medication administration. * Body weight less than 50 kilograms (kg) or greater than 100 kg