StudyFinder
A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA)
Recruiting
The purpose of the study is to see if ianalumab, compared to placebo, is effective and safe for treating wAIHA. A placebo looks like the study drug, ianalumab, but does not contain any active ingredient. Ianalumab belongs to a class of drugs called monoclonal antibodies. Monoclonal antibodies are molecules that can recognize and stick to a specific protein expressed on the cell surface or released free in the body. Participants will receive study drug (ianalumab or placebo) through the vein every 4 weeks (4 doses in total) during the treatment period.
Male or Female
18 years and over
Inclusion Criteria:
• people with documented primary or secondary wAIHA
• had an insufficient response to or relapsed after one or more treatments
• Hemoglobin concentration at screening between 5 g/dL and 10 g/dL and experiencing symptoms of anemia
• dose of supportive medication must be stable for at least 4 weeks
Exclusion Criteria:
• wAIHA due to disease involving bone marrow
• prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to starting the study
• active viral, bacterial or other infections that require systemic treatment at time of screening, or a history of recurrent clinically significant infection
• positive for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb)
• contact study staff for additional criteria
Blood Disorders
hemolytic anemia, wAIHA, warm autoimmune hemolytic anemia
Diondra Howard - howar709@umn.edu
Marshall Mazepa, MD
STUDY00018783