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NCT03395210 · ClinicalTrials.gov registry record · Phase 2
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
A Phase 2 study, sponsored by Principia Biopharma, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT03395210: Completed Phase 2 study, sponsored by Principia Biopharma, a Sanofi Company.
NCT03395210 is a Phase 2 study that has completed, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03395210, a Phase 2 study, has completed, sponsored by Principia Biopharma, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study 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.
Primary Outcome
The percentage of participants who achieved 2 or more consecutive platelet counts, separated by at least 5 days, of \>=50,000/ microliter (μL) and an increase of platelet count of \>=20,000/μL from baseline, by starting dose level and overall, without use of rescue medication in the 4 weeks prior to the latest elevated platelet count. 95% confidence interval (CI) was based on the Clopper-Pearson method. The average of the 2 screening results and the Cycle 1 Day 1 result were used as the baseline
Interventions
- DRUG Rilzabrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2025-12-11 |
| Phase | Phase 2 |
What the finished NCT03395210 record still lists
NCT03395210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Rilzabrutinib is the first listed.
NCT03395210 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03395210 about?
NCT03395210 is a clinical study titled "A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)". 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 beg...
What is the current status of trial NCT03395210?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2018-03-22. Estimated completion is 2025-12-11.
What interventions are being tested in trial NCT03395210?
The interventions under investigation include: Rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT03395210?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03395210's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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