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Tests treatment safety and results for Immune Thrombocytopenia
Official title Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
ClinicalTrials.gov ID: NCT07007962
What this study is testing
What is rilzabrutinib?
rilzabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for immune thrombocytopenia.
Also referred to as SAR444671.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Clovis, California, United States
- Los Angeles, California, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Danvers, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Albany, New York, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Ogden, Utah, United States
- Vienna, Austria
- Prague, Czechia
- Créteil, France
- Dijon, France
- Pessac, France
- Toulouse, France
- Leipzig, Germany
- Budapest, Hungary
- Kaposvár, Hungary
+ 14 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clovis, California, United States; Los Angeles, California, United States; New Orleans, Louisiana, United States; Boston, Massachusetts, United States; Danvers, Massachusetts, United States; Ann Arbor, Michigan, United States and 28 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.