Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind study of rilzabrutinib in patients with persistent or
chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count
>35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins.
Patients will receive rilzabrutinib or placebo 400mg twice daily.
For each patient, the study will last up to 60 weeks from the start of the Screening Period
to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to
24-week Blinded Treatment Period followed by a 28-week Open-Label Period. There is a 4-week
post dose follow-up.
Patients who respond per specified criteria at the end of the Open-Label Period will be able
to enter a 12-month Long-Term Extension (LTE).
Phase:
Phase 3
Details
Lead Sponsor:
Principia Biopharma Inc. Principia Biopharma, a Sanofi Company