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

Study on the Efficacy and Safety of an Investigational Medication in Adults with Immune Thrombocytopenia (ITP)

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 effectiveness and safety of an investigational medication in adults with immune thrombocytopenia (ITP) who did not respond to first-line treatment.

Participants in this study will take the investigational medication orally. The study includes several phases: a screening period, a primary analysis period, a long-term extension for some participants, and a follow-up period for eligible participants.

  • Who can participate: Adults aged 18 years and older with primary ITP who have received at least one first-line therapy and experienced a loss of response or relapse can participate. Participants must not have secondary ITP, Evans syndrome, or a history of certain other medical conditions.
  • Study details: Participants will take the investigational medication orally. The study focuses on monitoring the effects of the treatment through various participant actions.
Updated on 31 Oct 2025. Study ID: NCT07007962

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