At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 86 enrolled
Drug / intervention
Rilzabrutinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia
In Brief
A Phase 2 clinical trial evaluating Rilzabrutinib for Immune Thrombocytopenia. Completed, enrolled 86 participants across 31 sites in 8 countries.
Detailed Summary
This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count \<30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study was completed. Part B treatment dose was 400 mg twice daily.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia
CountriesAustralia, Bulgaria, Canada, Czechia, Netherlands, Norway, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartMar 2018
Primary CompletionJan 2023
Study CompletionDec 2025
TodayJul 2026
First PostedJan 10, 2018
Enrollment StartMar 22, 2018
Primary CompletionJan 31, 2023
Study CompletionDec 11, 2025
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.5 years ago
Interventions
Rilzabrutinibdrug
BTK inhibitor