A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
ConditionImmune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 2) of randomization
Have significant cardiovascular disease
Have a diagnosis or history of hematologic malignancy
Trial design
Treatments tested in this trial
- Pirtobrutinib
- Placebo
Treatment groups
68 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov