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

Immune Thrombocytopenia Treatment Study for Adults

Recruiting
18 years or above
All
Phase 3
60 participants needed
6 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 the effectiveness and safety of an investigational medication for adults with immune thrombocytopenia (ITP) who did not respond to initial treatments.

The focus of the study is to evaluate how well the investigational medication works and its safety in managing ITP symptoms. Participants will be observed for changes in their condition while using the treatment.

  • Who can participate: Adults 18 and older with primary ITP not responsive to first-line treatments may join. Exclusions include secondary ITP, certain blood disorders, or recent cancers.
  • Study details: Participants will take the investigational medication and be monitored for its effects on their ITP. This study will not involve a placebo.
Updated on 30 Apr 2026. Study ID: NCT07007962

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