RecruitingPhase 3NCT07007962

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

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


Sponsor

Sanofi

Enrollment

60 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called rilzabrutinib for people with immune thrombocytopenia. The study is currently recruiting participants at 36 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGrilzabrutinib

Pharmaceutical form:Tablet-Route of administration:Oral


Locations(36)

Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates)

Clovis, California, United States

University of Southern California (USC)

Los Angeles, California, United States

Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011

New Orleans, Louisiana, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mass General Brigham Cancer Institute

Danvers, Massachusetts, United States

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

Oregon Health and Sciences University

Portland, Oregon, United States

Community Cancer Trials of Utah-Investigational Site Number: 8400002

Ogden, Utah, United States

Investigational Site Number : 0400001

Vienna, Austria

Investigational Site Number : 2030002

Prague, Czechia

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 : 2760004

Leipzig, Germany

Investigational Site Number : 3480001

Budapest, Hungary

Investigational Site Number : 3480002

Kaposvár, Hungary

Investigational Site Number : 3800002

Meldola, Italy

Investigational Site Number : 3800004

Milan, Italy

Investigational Site Number : 3800006

Naples, Italy

Investigational Site Number : 3800007

Torino, 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 : 7240001

Barcelona, Spain

Investigational Site Number : 7240002

Burgos, Spain

Investigational Site Number : 7240007

Madrid, Spain

Investigational Site Number : 7240008

Madrid, Spain

Investigational Site Number : 7240005

Murcia, Spain

Investigational Site Number : 7240003

San Cristóbal de La Laguna, Spain

Investigational Site Number : 7240004

Seville, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07007962


Related Trials