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A study to test how well an oral medication called rilzabrutinib works and how safe it is for adults with immune thrombocytopenia (ITP) who did not respond to first-line treatments such as corticosteroids, intravenous immunoglobulin, and/or anti-D immunoglobulin.
EU CTIS ID: 2025-522070-36-00
What this study is testing
The main goal of this study is to investigate if rilzabrutinib can provide a long-lasting increase in platelet count in adults with primary ITP who fail first-line treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- I 01. Participant must be 18 or above years of age inclusive, at the time of signing the informed consent.
- I 10. Capable of giving signed informed consent as described in Appendix 1 Section 10.1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative (Appendix 1 Section 10.1.3).
- I 02. Male and female participants with a documented diagnosis of primary ITP in the medical history.
- I 03. Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.
- I 04. Participant received at least one course of first-line therapy per international guidelines or local standard of care (eg, oral or parenteral CS, IVIg, anti-D). Note: Participants may have received multiple courses of first-line therapy, either sequentially or in combination.
- I 05. History of platelet response while on-treatment with first-line therapy.
You likely can't join if
- E 01. Participants with diagnosis of secondary ITP.
- E 18. Participant received subsequent/advanced treatment for the treatment of ITP or was splenectomized before Study Day 1
- E 19. Participant received drugs known to potentially improve thrombocytopenia to treat other conditions within 5 times the elimination half-life of the drug or within 14 days of Study Day 1, whichever is longer, or the participant is planned to receive treatment with drugs known to potentially improve thrombocytopenia for any indication during the course of the study.
- E 10. HIV infection.
- E 20. Please see study protocol.
- E 21. Please see study protocol.
See the full eligibility criteria
Who can join
- I 01. Participant must be 18 or above years of age inclusive, at the time of signing the informed consent.
- I 10. Capable of giving signed informed consent as described in Appendix 1 Section 10.1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative (Appendix 1 Section 10.1.3).
- I 02. Male and female participants with a documented diagnosis of primary ITP in the medical history.
- I 03. Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.
- I 04. Participant received at least one course of first-line therapy per international guidelines or local standard of care (eg, oral or parenteral CS, IVIg, anti-D). Note: Participants may have received multiple courses of first-line therapy, either sequentially or in combination.
- I 05. History of platelet response while on-treatment with first-line therapy.
- I 06. Participant has loss of response, relapse, or steroid dependency.
- I 07. Please see study protocol.
- I 08. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- I 09. Adequate hematologic, hepatic, and renal function (hemoglobin >9 g/dL within 1 week prior to Study Day 1), absolute neutrophil count ≥1500/μL,, AST and ALT ≤1.5×upper limit of normal (ULN), albumin ≥3 g/dL, total bilirubin ≤1.5×ULN (unless the participant has documented Gilbert syndrome), estimated glomerular filtration rate (GFR) >50mL/min/1.73m² (CKD-EPI 2021 Creatinine Equation [Race-Free]), International normalized ratio (INR) and activated partial thromboplastin time (APTT) values are within 20% of the normal ranges.
What rules you out
- E 01. Participants with diagnosis of secondary ITP.
- E 18. Participant received subsequent/advanced treatment for the treatment of ITP or was splenectomized before Study Day 1
- E 19. Participant received drugs known to potentially improve thrombocytopenia to treat other conditions within 5 times the elimination half-life of the drug or within 14 days of Study Day 1, whichever is longer, or the participant is planned to receive treatment with drugs known to potentially improve thrombocytopenia for any indication during the course of the study.
- E 10. HIV infection.
- E 20. Please see study protocol.
- E 21. Please see study protocol.
- E 22. Please see study protocol.
- E 23. Please see study protocol.
- E 24. Please see study protocol.
- E 25. Received any investigational drug within 6 months or 5 half-lives, whichever is longer, or is participating in another clinical trial.
- E 26. Participant during pregnancy or nursing.
- E 02. Participants with a diagnosis of Evans syndrome.
- E 27. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- E 28. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- E 11. A history of active or latent tuberculosis (TB) (unless the participant has completed a full course of anti-tuberculosis therapy or it is documented by a specialist that the participant has been adequately treated and can begin treatment with an immunosuppressive agent). A positive test for TB (QuantiFERON-TB-Gold [QFT] or equivalent) performed at the screening visit or within the 3 months prior to screening.
- E 29. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the International Council for Harmonization Good Clinical Practice [GCP] Ordinance E6).
- E 30. Sensitivity to any of the study intervention, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- E 12. Participants with uncontrolled or active HBV infection: Participants with positive HBsAg and/or HBV DNA.
- E 13. Participants with active HCV infection: positive HCV-RNA and positive anti-HCV.
- E 14. Current drug or alcohol abuse.
- E 15. Refractory nausea and vomiting, malabsorption, external biliary shunt, significant bowel resection, or any other condition that would preclude adequate study drug absorption.
- E 16. Participants who have undergone major surgery within 28 days prior to Study Day 1 or have planned surgery in the time frame of the study.
- E 03. Participants with history of myelodysplastic syndrome
- E 17. Please see study protocol.
- E 04. Participant with history of or current life-threatening bleeding (eg., a bleed that results in hemodynamic instability or respiratory compromise) due to ITP.
- E 05. Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.
- E 06. Participants with history of solid organ transplant.
- E 07. Participants with history of coagulation or bleeding disorders, including genetic conditions, other than ITP.
- E 08. Please see the study protocol.
- E 09. Positive COVID-19 molecular test (if COVID-19 testing required per local guidelines to be determined for each site).
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.