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RECRUITING
NCT07007962
PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-10-24

Completion Date

2028-12-30

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

rilzabrutinib

Pharmaceutical form:Tablet-Route of administration:Oral

Locations (20)

University of Michigan Health - Michigan Medicine - University Hospital-Investigational Site Number: 8400001

Ann Arbor, Michigan, United States

Mayo Clinic_Investigational Site Number: 8400009

Rochester, Minnesota, United States

New York Oncology Hematology_Investigational Site Number: 8400010

Albany, New York, United States

Montefiore Medical Center-Investigational Site Number: 8400012

The Bronx, New York, United States

Community Cancer Trials of Utah_Investigational Site Number: 8400002

Ogden, Utah, United States

Investigational Site Number : 0400001

Vienna, Austria

Investigational Site Number: 2500003

Créteil, France

Investigational Site Number : 2500001

Dijon, France

Investigational Site Number : 2500002

Pessac, France

Investigational Site Number : 2500004

Toulouse, France

Investigational Site Number : 3480002

Kaposvár, Hungary

Investigational Site Number : 3800006

Naples, Italy

Investigational Site Number : 3800003

Vicenza, Italy

Investigational Site Number : 6160002

Gdansk, Poland

Investigational Site Number : 6160003

Skorzewo, Poland

Investigational Site Number : 6160004

Słupsk, Poland

Investigational Site Number : 7240002

Burgos, Spain

Investigational Site Number : 7240008

Madrid, Spain

Investigational Site Number : 7240005

Murcia, Spain

Investigational Site Number : 7240004

Seville, Spain