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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
BTK Inhibitor
Pirtobrutinib
Phase
2
Recruiting
A Phase 1/2, Dose-Finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
Related Resources:
Molecule Overview Trial Enrollment
NCT06721013
Key Inclusion Criteria
  • Diagnosis of primary immune thrombocytopenia (ITP), defined as isolated thrombocytopenia not associated with another known disease process
  • Documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/μL, to ≥1 prior line of therapy. Splenectomy is considered a line of therapy
  • Relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit
  • Platelet count <30,000/μL on 2 occasions more than 5 days apart in the 15 days before randomization
  • Adequate liver, renal, and hematologic function
  • Willing to follow contraception requirements
Key Exclusion Criteria
  • History of any thrombotic or embolic event within 12 months before screening
  • Transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization
  • Significant cardiovascular disease
  • Diagnosis or history of hematologic malignancy
  • Hepatitis B virus (HBV) defined as positive for hepatitis B surface antigen (HBsAg) or polymerase chain reaction (PCR) positive for HBV DNA
  • Hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV RNA
a
Approximately 9-18 participants will be assigned to sequential dose levels (3-6 per dose level), starting at the lowest dose level of oral pirtobrutinib, given once daily for 12 weeks. 
b
Approximately 10 patients per treatment group will be equally randomized to evaluate at least two pirtobrutinib dose levels versus placebo. 
c
Stable platelet response rate is defined as the proportion of patients who achieve platelet count ≥50 k/µL on ≥4 of 6 consecutive biweekly visits between weeks 14-24, without rescue therapy and prohibited concomitant medications affecting efficacy.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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