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Taking people in United StatesPhase 3

Rilzabrutinib taken by mouth for immune thrombocytopenia after first treatment failed

Tests rilzabrutinib in adults with immune thrombocytopenia whose first treatment failed.

Key facts

Who runs it
Sanofi
Where
Albany, Ann Arbor, Boston, Clovis, Danvers, Greenville, Los Angeles, Minneapolis, New Orleans, Ogden, Peoria, Portland, Rochester, Seattle, The Bronx, Torrance, and Washington D.C., United StatesSee the 18 sitesAlso in 9 other countries, 46 sites
Trial code
Registry title
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Status
Recruiting
Phase
Phase 3
People taking part
60 people, planned
Started
24 Oct 2025
Expected to end
30 Dec 2028
Type of study
Interventional
Treatments tested
  • rilzabrutinib
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary immune thrombocytopenia (ITP, a low platelet count caused by the immune system) whose first treatment stopped working. Everyone takes rilzabrutinib by mouth.

Age
18 years and older
Sex
Men and women
Disease stage
Primary ITP, documented in the medical history. The disease came back, the treatment stopped working, or the person depends on steroids.
Earlier treatment
At least one course of first-line therapy, with a response while on it. People who had advanced therapy for ITP or had their spleen removed cannot join.

Main reasons for not taking part

  • Secondary ITP (caused by another illness), Evans syndrome or past myelodysplastic syndrome
  • Lymphoma, leukemia or any cancer in the past 5 years, except non-melanoma skin cancer
  • Past solid organ transplant
  • Other clotting or bleeding disorders, including genetic ones
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participant received advanced therapy for ITP or was splenectomized
  • 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
  • Participants with Secondary ITP
  • Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Where in United States

Also in 9 other countries, 46 sites

  • New York Oncology Hematology Site Number: 8400010Albany, United StatesTaking people
  • University of Michigan Health - Michigan Medicine - University Hospital Site Number: 8400001Ann Arbor, United StatesTaking people
  • Beth Israel Deaconess Medical Center Site Number: 8400019Boston, United StatesTaking people
  • Massachusetts General Hospital Site Number: 8400004Boston, United StatesTaking people
  • Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates) Site Number: 8400005Clovis, United StatesTaking people
  • Mass General/North Shore Cancer Center Site Number: 8400020Danvers, United StatesTaking people
  • East Carolina University Site Number: 8400003Greenville, United StatesTaking people
  • University of Southern California (USC) Norris Comprehensive Cancer Center Site Number: 8400015Los Angeles, United StatesTaking people
  • M Health Center for Bleeding and Clotting Disorders Site Number: 8400013Minneapolis, United StatesTaking people
  • Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011New Orleans, United StatesTaking people
  • Community Cancer Trials of Utah Site Number: 8400002Ogden, United StatesTaking people
  • Bleeding and Clotting Disorders Institute Site Number: 8400018Peoria, United StatesTaking people
  • Oregon Health & Science University - Knight Cancer Institute Site Number: 8400006Portland, United StatesTaking people
  • Rochester, MinnesotaHospital not named in the registryTaking people
  • University of Washington Site Number: 8400008Seattle, United StatesTaking people
  • Montefiore Medical Center-Investigational Site Number: 8400012The Bronx, United StatesTaking people
  • The Lundquist Institute for Biomedical Innovation - Harbor-UCLA Medical Center Site Number: 8400017Torrance, United StatesTaking people
  • MedStar Georgetown University Hospital Site Number: 8400014Washington D.C., United StatesTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • rilzabrutinibTreatment being tested

    400 mg BID

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Rilzabrutinib taken by mouth for immune thrombocytopenia after first treatment failedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Publications
Record updated
12 November 2026