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

Evaluation of the Efficacy and Safety of Oral Investigational Medication in Adults with Immune Thrombocytopenia

Recruiting
18 years or above
All
Phase 3
60 participants needed
9 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Immune Thrombocytopenia
  • Age: 18 years or above
  • Gender: All

Key Inclusion Criteria:

  • Male or female participants aged 18 years and older with a documented diagnosis of primary ITP in the medical history
  • Participant received at least one course of first-line therapy and had a history of response while on treatment
  • Participant has loss of response, relapse, or steroid dependency

Key Exclusion Criteria:

  • Participants with Secondary ITP
  • Participants with Evans syndrome or history of myelodysplastic syndrome
  • Participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy.
  • Participants with history of solid organ transplant
  • Participants with history of coagulation or bleeding disorders other than ITP, including genetic conditions, other than ITP
  • Participant received advanced therapy for ITP or was splenectomized
  • Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

This study investigates immune thrombocytopenia (ITP).

The study evaluates the safety and effectiveness of an oral investigational medication in adults with ITP who did not respond to first-line treatment.

  • Who can participate: Adults aged 18 and older with a history of primary immune thrombocytopenia who have failed first-line treatment can participate.
  • Study details: Participants will take an oral investigational medication.
  • Study timelines: The study will last up to 28 weeks with an additional 24-week follow-up period for eligible participants.
Updated on 24 May 2026. Study ID: NCT07007962

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