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

• Status: Not yet recruiting
• Trial end date: 2029-01-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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 <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 other immunologic disease requiring immunosuppressant treatments that are not allowed in this study

• 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) for adults or estimated glomerular filtration rate (eGFR)≤60 mL/min for adolescent

• 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)

• 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.