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

Study of Oral Investigational Medication for Adults with Immune Thrombocytopenia

Recruiting
18 years or above
All
Phase 3
60 participants needed
12 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) in adults who did not respond to first-line treatment. The purpose of this study is to explore the effects of the investigational medication on this condition.

The study evaluates the safety and effectiveness of the investigational medication. It looks at how well the medication works and any possible side effects it might cause.

  • Who can participate: Adults aged 18 and older with a documented diagnosis of primary ITP, who have previously received first-line therapy and experienced a relapse or steroid dependency, may participate.
  • Study details: Participants will take an oral investigational medication to assess its impact. The study includes multiple phases, but only eligible participants will proceed to the long-term extension and follow-up periods.
  • Study timelines: The study will last up to 28 weeks with an additional 24-week follow-up period for eligible participants.
Updated on 18 Jun 2026. Study ID: NCT07007962

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