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NCT07007962PHASE3Recruiting

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

Sanofi

Start Date

10/24/2025

Completion Date

12/30/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

rilzabrutinib

Interested in This Trial?

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Conditions

Immune Thrombocytopenia

Locations

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

Clovis, California 93611

United States

University of Southern California (USC)

Los Angeles, California 90089

United States

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

New Orleans, Louisiana 70112

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Mass General Brigham Cancer Institute

Danvers, Massachusetts 01923

United States

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

Ann Arbor, Michigan 48109

United States

Mayo Clinic_Investigational Site Number: 8400009

Rochester, Minnesota 55905

United States

New York Oncology Hematology-Investigational Site Number: 8400010

Albany, New York 12208

United States

Montefiore Medical Center-Investigational Site Number: 8400012

The Bronx, New York 10467

United States

Oregon Health and Sciences University

Portland, Oregon 97239

United States

Community Cancer Trials of Utah-Investigational Site Number: 8400002

Ogden, Utah 84405

United States

Investigational Site Number : 0400001

Vienna, 1140

Austria

Investigational Site Number : 2030002

Prague, 12800

Czechia

Investigational Site Number: 2500003

Créteil, 94000

France

Investigational Site Number : 2500001

Dijon, 21079

France

Investigational Site Number : 2500002

Pessac, 33604

France

Investigational Site Number : 2500004

Toulouse, 31059

France

Investigational Site Number : 2760004

Leipzig, 04103

Germany

Investigational Site Number : 3480001

Budapest,

Hungary

Investigational Site Number : 3480002

Kaposvár, 7400

Hungary

Investigational Site Number : 3800002

Meldola,

Italy

Investigational Site Number : 3800004

Milan, 20162

Italy

Investigational Site Number : 3800006

Naples, 80131

Italy

Investigational Site Number : 3800007

Torino, 10126

Italy

Investigational Site Number : 3800003

Vicenza, 36100

Italy

Investigational Site Number : 6160002

Gdansk, 80-219

Poland

Investigational Site Number : 6160003

Skorzewo, 60-185

Poland

Investigational Site Number : 6160004

Słupsk, 76-200

Poland

Investigational Site Number : 7240001

Barcelona, 8003

Spain

Investigational Site Number : 7240002

Burgos, 9006

Spain

Investigational Site Number : 7240007

Madrid, 28007

Spain

Investigational Site Number : 7240008

Madrid, 28046

Spain

Investigational Site Number : 7240005

Murcia, 30008

Spain

Investigational Site Number : 7240003

San Cristóbal de La Laguna,

Spain

Investigational Site Number : 7240004

Seville, 41013

Spain