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

Key Inclusion Criteria:

• 18 years and older at time of signing consent

• Patients with primary or secondary wAIHA documented by positive direct antiglobulintest specific for anti-IgG or anti-IgA, who had an insufficient response to, orrelapsed after at least one line of treatment, including patients with steroidresistance, 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 torandomization into the study

Key Exclusion Criteria:

• wAIHA secondary to hematologic disease involving bone marrow (e.g., CLL) or anotherimmunologic disease requiring prohibited medication as per protocol. Patients withautoimmune diseases after wash-out from the treatments are allowed.

• Presence of other forms of AIHA (cold or intermediate forms), Evans Syndrome orother cytopenias

• Prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior torandomization, or without hematological response to the last course of B-celldepleting 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 recurrentclinically significant infection

• Positivity for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitisB core antibody (HBcAb). HBcAb positive patients can be enrolled if HBsAg negative,HBV DNA negative, no pre-existing liver fibrosis is present and antiviralprophylaxis is given.

• Known history of primary or secondary immunodeficiency, or a positive human immunedeficiency virus (HIV) test result

• Live or live-attenuated vaccination within 4 weeks before randomization

• History of splenectomy

Other protocol-defined Inclusion/Exclusion may apply.