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

Launched by NOVARTIS PHARMACEUTICALS · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ianalumab for patients with a condition known as warm autoimmune hemolytic anemia (wAIHA). This condition causes the body to destroy its own red blood cells, leading to anemia, which is a shortage of red blood cells that can make you feel tired and weak. The trial aims to see if ianalumab is effective and safe compared to a placebo (a harmless pill with no active treatment) for patients who have already tried at least one other treatment that didn't work.

To be eligible for this study, participants need to be at least 18 years old and have been diagnosed with wAIHA, showing specific test results. They should also have low levels of hemoglobin, which is a protein in red blood cells, and experience symptoms related to anemia. Participants will be closely monitored throughout the study, and everyone will receive either ianalumab or the placebo. It's important to note that people with certain other medical conditions, recent infections, or specific treatments may not qualify for this trial. If you or a loved one is considering participation, it's a great opportunity to potentially access a new treatment while contributing to important medical research.

Gender

ALL

Eligibility 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 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
• 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, 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
• • Other protocol-defined Inclusion/Exclusion may apply.

Trial Officials