A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
Completed · Phase 2
Conditions studied: Immune Thrombocytopenia
In brief
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.
Key facts
- Study ID
- NCT03395210
- Run by
- Principia Biopharma, a Sanofi Company
- People needed
- 86
- Starts
- 2018-03-22
- Expected to finish
- 2025-12-11
- Last updated by the study team
- 2026-02-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients, aged 18 to 80 years old
- Immune-related ITP (both primary and secondary)
You may not qualify if…
- Pregnant or lactating women
- Current drug or alcohol abuse
- History of solid organ transplant
- Positive screening for HIV, hepatitis B, or hepatitis C
Where it is running
- Bleeding and Clotting Disorders Institute- Site Number : 1087 — Peoria, Illinois, United States
- RCCA MC LLC- Site Number : 1091 — Bethesda, Maryland, United States
- Massachusetts General Hospital Cancer Center- Site Number : 1092 — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center- Site Number : 1099 — Boston, Massachusetts, United States
- Mid Michigan Medical Center- Site Number : 1086 — Midland, Michigan, United States
- New York Presbyterian Hospital/Weill Cornell Medical Center- Site Number : 1097 — New York, New York, United States
- Pitt County Memorial Hospital- Site Number : 1095 — Greenville, North Carolina, United States
- Seattle Cancer Care Alliance Site Number : 1098 — Seattle, Washington, United States
- Investigational Site Number : 105 — Canberra, Australian Capital Territory, Australia
- Investigational Site Number : 104 — Sydney, New South Wales, Australia
- Investigational Site Number : 102 — Woolloongabba, Queensland, Australia
- Investigational Site Number : 101 — Clayton, Victoria, Australia
- Investigational Site Number : 106 — Parkville, Victoria, Australia
- Investigational Site Number : 103 — Perth, Western Australia, Australia
- Investigational Site Number : 213 — Pleven, Bulgaria
- Investigational Site Number : 214 — Sofia, Bulgaria
- Investigational Site Number : 211 — Varna, Bulgaria
- Investigational Site Number : 1161 — Toronto, Ontario, Canada
- Investigational Site Number : 1162 — Montreal, Quebec, Canada
- Investigational Site Number : 431 — Brno, Czechia
- Investigational Site Number : 433 — Hradec Králové, Czechia
- Investigational Site Number : 434 — Ostrava - Poruba, Czechia
- Investigational Site Number : 432 — Prague, Czechia
- Investigational Site Number : 727 — Rotterdam, Netherlands
- Investigational Site Number : 728 — The Hague, Netherlands
Full record on ClinicalTrials.gov
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