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RecruitingPhase 3

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

Sanofi · NCT07007962

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
60
US sites recruiting
12
Study start
October 24, 2025
Record last updated
June 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: rilzabrutinib

Conditions: Immune Thrombocytopenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

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

    Clovis, CA 93611

  • University of Southern California (USC)

    Los Angeles, CA 90089

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

    New Orleans, LA 70112

  • Massachusetts General Hospital Cancer Center

    Boston, MA 02114

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

  • Mass General Brigham Cancer Institute

    Danvers, MA 01923

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

    Ann Arbor, MI 48109

  • Mayo Clinic_Investigational Site Number: 8400009

    Rochester, MN 55905

  • New York Oncology Hematology-Investigational Site Number: 8400010

    Albany, NY 12208

  • Montefiore Medical Center-Investigational Site Number: 8400012

    The Bronx, NY 10467

  • Oregon Health and Sciences University

    Portland, OR 97239

  • Community Cancer Trials of Utah-Investigational Site Number: 8400002

    Ogden, UT 84405

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in… (NCT07007962) | Bored Studies