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

NCT07007962

RecruitingPhase 3

Sponsor: Sanofi

Conditions: Immune Thrombocytopenia

Interventions: rilzabrutinib

Countries: United States, Austria, Czechia, France, Germany, Hungary, Italy, Poland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (36)
  • Clovis, California, United States
  • Los Angeles, California, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Danvers, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • Albany, New York, United States
  • The Bronx, New York, United States
  • Portland, Oregon, United States
  • Ogden, Utah, United States
  • Vienna, Austria
  • Prague, Czechia
  • Créteil, France
  • Dijon, France
  • Pessac, France
  • Toulouse, France
  • Leipzig, Germany
  • Budapest, Hungary
  • Kaposvár, Hungary
  • Meldola, Italy
  • Milan, Italy
  • Naples, Italy
  • Torino, Italy
  • Vicenza, Italy
  • Gdansk, Poland
  • Skorzewo, Poland
  • Słupsk, Poland
  • Barcelona, Spain
  • + 6 more on CT.gov