For Healthcare Professionals

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


About the study

The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


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 >=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
  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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Warm Autoimmune Hemolytic Anemia (wAIHA)

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Jan 9, 2029

Treatment type



Novartis identifier


Study number


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