A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

Key Inclusion Criteria:

1. 18 years and older at time of signing consent
2. Patients with primary or secondary wAIHA documented by positive direct antiglobulin test specific for anti-IgG or anti-IgA, who had an insufficient response to, or relapsed after at least one line of treatment, including patients with steroid resistance, dependence or intolerance
3. Hemoglobin concentration at screening and at Week 1 >=5 g/dL and <10 g/dL, associated with presence of symptoms related to anemia
4. The dose of supportive care must be stable for at least 4 weeks prior to randomization into the study

Key Exclusion Criteria:

1. wAIHA secondary to hematologic disease involving bone marrow (e.g., CLL) or another immunologic disease requiring prohibited medication as per protocol. Patients with autoimmune diseases after wash-out from the treatments are allowed.
2. Presence of other forms of AIHA (cold or intermediate forms), Evans Syndrome or other cytopenias
3. Prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to randomization, or without hematological response to the last course of B-cell depleting therapy
4. Neutrophils: <1000/mm3
5. Serum creatinine >1.5 × upper limit of normal (ULN)
6. Immunoglobulin G (IgG) <5g/L
7. Active viral, bacterial or other infections (including tuberculosis and SARS-CoV-2) requiring systemic treatment at time of screening, or history of recurrent clinically significant infection
8. Positivity for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb). HBcAb positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given.
9. Known history of primary or secondary immunodeficiency, or a positive human immune deficiency virus (HIV) test result
10. Live or live-attenuated vaccination within 4 weeks before randomization
11. History of splenectomy

Other protocol-defined Inclusion/Exclusion may apply.