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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSanofi

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • rilzabrutinib

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators