A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
Key facts
- Who runs it
- Principia Biopharma, a Sanofi Company
- Where
- Bethesda, Boston, Greenville, Midland, New York, Peoria, and Seattle, United StatesSee the 8 sitesAlso in 7 other countries, 23 sites
- Trial code
- NCT03395210
- EudraCT 2023-509397-39
- U1111-1260-4044
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 86 people enrolled
- Started
- 22 Mar 2018
- Ended
- 11 Dec 2025
- Type of study
- Interventional
- Treatments tested
- Rilzabrutinib
- Record updated
- 23 February 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Male or female patients, aged 18 to 80 years old
- Immune-related ITP (both primary and secondary)
Who cannot take part
- Current drug or alcohol abuse
- History of solid organ transplant
- Positive screening for HIV, hepatitis B, or hepatitis C
- Pregnant or lactating women
Where in United States
Also in 7 other countries, 23 sites
- RCCA MC LLC- Site Number : 1091Bethesda, United StatesNo longer taking part
- Beth Israel Deaconess Medical Center- Site Number : 1099Boston, United StatesNo longer taking part
- Massachusetts General Hospital Cancer Center- Site Number : 1092Boston, United StatesNo longer taking part
- Pitt County Memorial Hospital- Site Number : 1095Greenville, United StatesNo longer taking part
- Mid Michigan Medical Center- Site Number : 1086Midland, United StatesNo longer taking part
- New York Presbyterian Hospital/Weill Cornell Medical Center- Site Number : 1097New York, United StatesNo longer taking part
- Bleeding and Clotting Disorders Institute- Site Number : 1087Peoria, United StatesNo longer taking part
- Seattle Cancer Care Alliance Site Number : 1098Seattle, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Rilzabrutinib (PRN1008) DailyTreatment being tested
Part A approximately 60 patients: Up to 24 weeks open-label treatment with PRN1008 400mg BID; safety and dose evaluation. Patients who respond to PRN1008 per protocol may enter a long-term extension. Part B approximately 25 patients: Up to 24 weeks open-label treatment with PRN1008 400mg BID; safety and dose evaluation. Patients who respond to PRN1008 per protocol may enter a long-term extension
Treatment: Rilzabrutinib
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 23 February 2026