A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Key facts
- Where
- Austin, Houston, Los Angeles, Miami, New Orleans, Palo Alto, Peoria, Rochester, The Woodlands, and Washington D.C., United StatesSee the 10 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT06721013, who can take part
Where in United States
- Texas Oncology - Central SouthAustin, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- University of Miami Hospital and Clinics Sylvester Comprehensive Cancer CenterMiami, United StatesNot yet recruiting
- Ochsner Clinic FoundationNew Orleans, United StatesTaking people
- Stanford UniversityPalo Alto, United StatesTaking people
- Bleeding and Clotting Disorders InstitutePeoria, United StatesNot yet recruiting
- Mayo ClinicRochester, United StatesTaking people
- Texas Oncology- Gulf CoastThe Woodlands, United StatesTaking people
- MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06721013EU 2024-518502-40-00
- Record updated
- 4 November 2026
- Original description
The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.Read full original descriptionShow less
A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur. The phase 2 part of the study will further investigate efficacy and safety of multiple pirtobrutinib dosages versus placebo.
The study drug will be administered orally in participants with Primary Immune Thrombocytopenia (ITP). Blood tests will be performed to check how much pirtobrutinib gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 16 weeks for phase 1 dose-escalation and 28 weeks for phase 2 dose-optimization, excluding screening.
Inclusion: Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process; Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy; Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit; Have a platelet count less than 30,000/μL on 2 occasions at least 5 days apart in the 15 days before randomization; Have adequate liver, renal, and hematologic functions as defined by a table; Are willing to follow contraception requirements.
Exclusion: Have a history of any thrombotic or embolic event within 12 months before screening; Have significant cardiovascular disease; Have a diagnosis or history of hematologic malignancy; Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA); Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA); Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization.