Ph3 Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP) - NCT04562766

This a randomized, double-blind study of rilzabrutinib in approximately 194 patients, aged 12 and older, with persistent or chronic ITP. Eligible patients must have an average platelet count of <30,000/μL on two counts (with no count higher than <35,000/μL) at least 5 days apart in the 14 days before treatment begins. The double-blind treatment period is 12-24 weeks depending on platelet response, followed by a 28 week open label period. Patients who respond to rilzabrutinib may enter a long term-extension.

After the last dose of rilzabrutinib there will be a 4-week safety follow-up visit.