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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2028
  • participants needed
    60
  • sponsor
    Sanofi
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Updated on 23 April 2026
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Summary

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.

Details
Condition Immune Thrombocytopenia
Age 18years or above
Clinical Study IdentifierNCT07007962
SponsorSanofi
Last Modified on23 April 2026

Eligibility

 Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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