Ensayos clínicos

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.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.