A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Key facts
- Who runs it
- Eli Lilly and Company
- Where
- Bologna, Milan, Rome, and Trieste, ItalySee the 4 sitesAlso in 9 other countries, 40 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 68 people, planned
- Started
- 30 Jul 2025
- Expected to end
- Feb 2029
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Pirtobrutinib
- Placebo
- Record updated
- 4 November 2026
Who can take part
- Age
- 18 years to 64 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
Also in 9 other countries, 40 sites
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyTaking people
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- Pirtobrutinib Phase 1Treatment being tested
Pirtobrutinib administered orally
Treatment: Pirtobrutinib
- Pirtobrutinib Phase 2Treatment being tested
Pirtobrutinib administered orally
Treatment: Pirtobrutinib
- Placebo Phase 2Placebo, for comparison
Placebo administered orally
Treatment: Placebo
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
- Fit questions
- Built from NCT06721013, who can take part
- Record updated
- 4 November 2026