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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 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.

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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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2025-10-24
Est. Completion 2028-12-30
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT07007962

The ClinicalTrials.gov registry entry for NCT07007962 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 114-participant average among 6 other Immune Thrombocytopenia trials with a reported enrollment target (47% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 4 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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