At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pirtobrutinib (drug), Placebo (drug)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- Pirtobrutinib — drug: Administered orally · Placebo — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 68
- Started
- 2025-07-30
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for immune thrombocytopenia (itp)
- • Phase1/Phase2 - 68 participants
- • The purpose of the phase 1 part of this study was to evaluate how well pirtobrutinib is tolerated and what side effects may occur
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with immune thrombocytopenia (itp)
Where?
- • Bristol - Bristol Haematology and Oncology Centre
- • Leeds - St James's University Hospital
- • Leicester - Leicester Royal Infirmary
- • London - Royal London Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of therapy
What the study is looking for
- ✓Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process
- ✓Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit
- ✓Have a blood clotting cell count less than 30,000/μL on 2 occasions at least 5 days apart in the 15 days before randomization
- ✓Have adequate liver, kidney, and blood functions as defined by a table
- ✓Are willing to follow contraception requirements
Who cannot take part
- ✗Have a history of any thrombotic or embolic event within 12 months before screening
- ✗Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase...
- ✗Have significant cardiovascular disease
- ✗Have a diagnosis or history of blood cancer
- ✗Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction...
See the full criteria
Where Is This Study? (5 UK sites)
Bristol Haematology and Oncology Centre
Bristol BS2 8ED, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Royal London Hospital
London E1 1FR, United Kingdom
Hammersmith Hospital
London W12 0HS, United Kingdom
How to Get in Touch
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
