Recruiting
Phase 3

Rilzabrutinib

Sponsor:

Sanofi

Code:

NCT07007962

Conditions

Immune Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

rilzabrutinib

Study Details

Brief 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.

Conditions

Immune Thrombocytopenia

Study ID

NCT07007962

Start date

Oct 24, 2025

Status verified date

Jun, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Nov 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rilzabrutinib

400 mg BID

Interventions

rilzabrutinib

Pharmaceutical form:Tablet-Route of administration:Oral

Primary outcome measure

  • Durable platelet response [ Time Frame: Until Week 28 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

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

Recruiting

Clovis, California, United States, 93611

University of Southern California (USC)

Recruiting

Los Angeles, California, United States, 90089

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

Recruiting

New Orleans, Louisiana, United States, 70112

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Mass General Brigham Cancer Institute

Recruiting

Danvers, Massachusetts, United States, 01923

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Mayo Clinic_Investigational Site Number: 8400009

Recruiting

Rochester, Minnesota, United States, 55905

New York Oncology Hematology-Investigational Site Number: 8400010

Recruiting

Albany, New York, United States, 12208

Montefiore Medical Center-Investigational Site Number: 8400012

Recruiting

The Bronx, New York, United States, 10467

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97239

Community Cancer Trials of Utah-Investigational Site Number: 8400002

Recruiting

Ogden, Utah, United States, 84405

More Information

Sponsor

Sanofi

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-06-22.