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

Study on Medicine 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 evaluate an investigational medication's effect on ITP.

The study focuses on assessing the safety and effectiveness of the investigational medication for ITP. It evaluates how participants respond to the treatment in terms of safety and efficacy.

  • Who can participate: Adults aged 18 and older with primary ITP who have failed first-line treatment can participate. Participants must have experienced a loss of response, relapse, or steroid dependency.
  • Study details: Participants will receive an investigational medication to assess its effects on ITP. The study will monitor safety and treatment response. An inactive substance, called a placebo, that looks like the investigational medicine but does not contain any medicine, may be used.
Updated on 18 Jun 2026. Study ID: NCT07007962

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