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

Eligibility 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 and at Week 1 \>=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
• * 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, or without hematological response to the last course of B-cell depleting therapy
• * 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