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NCT07007962 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
A Phase 3 study of Immune Thrombocytopenia, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 10
- Study locations
NCT07007962: Recruiting Phase 3 study of Immune Thrombocytopenia, sponsored by Sanofi.
NCT07007962 is a Phase 3 study of Immune Thrombocytopenia that is actively recruiting participants, run by Sanofi. The registered enrollment target is 60 participants, below the 114-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (47% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07007962, a Phase 3 study of Immune Thrombocytopenia, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.
Primary Outcome
Defined as the percentage of participants able to achieve platelet counts ≥50 000/μL (or ≥30 000/μL and \<50 000/μL and at least double from baseline) for ≥50% of 6 biweekly scheduled platelet measurements and at least 4 non-missing, biweekly visits during the last 12 weeks of the primary analysis period (PAP) in absence of rescue therapy
Conditions Studied
Interventions
- DRUG rilzabrutinib
Study Locations (10)
Other
- Investigational Site Number: 2500003 - Créteil
- Investigational Site Number : 2500001 - Dijon
- Investigational Site Number : 2500002 - Pessac
- Investigational Site Number : 2500004 - Toulouse
- Investigational Site Number : 3480002 - Kaposvár
- Investigational Site Number : 6160003 - Skorzewo
- Investigational Site Number : 6160004 - Słupsk
Minnesota
- Mayo Clinic_Investigational Site Number: 8400009 - Rochester
New York
- New York Oncology Hematology_Investigational Site Number: 8400010 - Albany
Utah
- Community Cancer Trials of Utah_Investigational Site Number: 8400002 - Ogden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 3 |
What NCT07007962 shows while recruiting
NCT07007962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 114-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Immune Thrombocytopenia appearing as the primary indexed condition, and to 1 intervention - of which rilzabrutinib is the first listed.
NCT07007962 lists 10 locations in 4 states (Other, Minnesota, New York).
Frequently Asked Questions
What is clinical trial NCT07007962 about?
NCT07007962 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment". This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-ter...
What is the current status of trial NCT07007962?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2025-10-24. Estimated completion is 2028-12-30.
What conditions does trial NCT07007962 study?
This clinical trial studies the following conditions: Immune Thrombocytopenia.
What interventions are being tested in trial NCT07007962?
The interventions under investigation include: rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT07007962?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07007962 being conducted?
This trial has 10 study locations across Minnesota, New York, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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