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

Study on the Effects of an Investigational Medication in Adults with Immune Thrombocytopenia

Recruiting
18 years or above
All
Phase 3
60 participants needed
2 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 primary ITP
  • Participant received at least a 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
  • 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 the effects of an investigational medication on adults with Immune Thrombocytopenia (ITP) who have not responded to first-line treatments. The purpose of this study is to assess how early immune modulation with the investigational medication can impact the condition in these patients.

Participants in this study will receive the investigational medication and will be monitored for changes in their condition. The study involves a screening period, a primary analysis period, and a long-term extension for some participants. There will also be a follow-up period for eligible participants to ensure their safety and to gather additional data on the investigational medication's effects.

  • Who can participate: Adults aged 18 years and older with primary ITP who have previously responded to first-line therapy but have since lost response, relapsed, or become steroid-dependent are eligible. Participants must not have secondary ITP, certain blood disorders, recent malignancies, or a history of organ transplant.
  • Study details: Participants will take the investigational medication and their health will be monitored throughout the study. The study is open-label, meaning all participants will know they are receiving the investigational medication.
Updated on 12 Jan 2026. Study ID: NCT07007962

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