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

Key Inclusion Criteria: 18 years and older at time of signing consent 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 Hemoglobin concentration at screening >=5 g/dL and <10 g/dL, associated with presence of symptoms related to anemia The dose of supportive care must be stable for at least 4 weeks prior to randomization into the study Key Exclusion Criteria: 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. Presence of other forms of AIHA (cold or intermediate forms), Evans Syndrome or other cytopenias Prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to randomization Neutrophils: <1000/mm3 Serum creatinine >1.5 × upper limit of normal (ULN) Immunoglobulin G (IgG) <5g/L 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 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. Known history of primary or secondary immunodeficiency, or a positive human immune deficiency virus (HIV) test result Live or live-attenuated vaccination within 4 weeks before randomization History of splenectomy Other protocol-defined Inclusion/Exclusion may apply.