A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
Key facts
- Who runs it
- Principia Biopharma Inc.
- Where
- Bulgaria, Czechia, and Netherlands6 sites in 3 countriesChoose a country to see its sites
- Status
- Completed
- Phase
- Phase 1/2
- People taking part
- 12 people enrolled
- Started
- 20 Mar 2018
- Ended
- 11 Dec 2025
- Type of study
- Interventional
- Record updated
- 25 November 2025
Who can take part
- Age
- 18 years and older
- 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
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
Part A: To characterize the safety and tolerability of up to four dose levels of rilzabrutinib in patients with ITP Part A: To explore the clinical activity of up to four dose levels of rilzabrutinib in relapsed/refractory patients with ITP Part B: To characterize the safety and tolerability of 400 mg BID dose of rilzabrutinib in patients with ITP Part B: To further explore the clinical activity and durability of response of the selected dose of 400 mg BID of rilzabrutinib in patients with ITP who have relapsed or have an insufficient response to prior therapies Part B: To evaluate the platelet response to rilzabrutinib therapy in the first 8 weeks of active treatment for the achievement of the primary endpoint
Data and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of Rilzabrutinib (PRN1008), an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenia
- Record updated
- 25 November 2025