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RECRUITING Phase 3

Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

NCT07007962 · View on ClinicalTrials.gov ↗

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

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07007962

The ClinicalTrials.gov registry entry for NCT07007962 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07007962 reports 10 study locations spanning 4 distinct geographic areas — top geographies include Other, Minnesota, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07007962?

The interventions under investigation include: rilzabrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07007962?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial