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

Launched by SANOFI · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called rilzabrutinib for adults with a condition known as Immune Thrombocytopenia (ITP). ITP is a disorder where your immune system mistakenly attacks and lowers the number of platelets in your blood, which can lead to easy bruising or bleeding. This trial aims to see how effective and safe rilzabrutinib is in people who did not respond well to their first treatment for ITP. The study will take place in multiple countries and involves a screening phase, a main analysis phase lasting up to 28 weeks, and a follow-up period for some participants.

To participate, you must be at least 18 years old and have been diagnosed with primary ITP, meaning it’s not caused by another condition. You should have already tried at least one treatment that initially worked for you but later failed. However, this trial is not for individuals with certain other conditions, such as secondary ITP or a history of specific cancers. If you join, you'll be monitored closely throughout the study, and your health will be assessed regularly to understand how well the treatment is working for you. It’s important to note that the trial is not yet recruiting participants, so it may be a while before you can enroll.

Gender

ALL

Eligibility criteria

• 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.