This study involves patients with primary immune thrombocytopenia, which is a condition where the body’s defense system mistakenly attacks and destroys its own platelets. Platelets are blood cells that help stop bleeding by forming clots. When platelet levels become too low, patients may experience bleeding problems. The study focuses on patients who did not respond well enough to or had their condition return after initial treatment with steroid medications. The study will test a medicine called ianalumab, which is also known by its code name VAY736, given as an infusion into a vein. This medicine will be compared to placebo, and both will be given together with another medicine called eltrombopag, which is taken by mouth. Some patients may also receive other supportive medications during the study, including antihistamines, pain relievers, normal human immunoglobulins, medicines that reduce stomach acid, glucocorticoids, and antiviral medicines like entecavir if needed.
The purpose of the study is to find out if adding ianalumab to eltrombopag can help patients go longer without their treatment failing compared to adding placebo to eltrombopag. Treatment failure means that platelet counts remain too low, that rescue treatments are needed, that new treatments for the condition must be started, that the eltrombopag dose cannot be reduced or stopped as planned, or that death occurs. The study will also look at how many patients achieve normal or near-normal platelet counts, how long these improvements last, how safe the treatment is, whether bleeding events occur, and how the treatment affects patients’ daily symptoms like tiredness and overall quality of life.
Patients who join the study will be randomly assigned to receive either ianalumab or placebo, both given along with eltrombopag. The study treatment period will last for several months, during which patients will have regular visits to check their platelet counts, monitor their overall health, and assess any side effects. Blood samples will be taken to measure the levels of certain immune cells and to check how the body processes the study medicine. After the main treatment period ends, patients will continue to be followed to see how long the benefits of treatment last and to monitor their safety.
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