NCT07007962 · Sanofi
Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
(LUNA 4)
What this study is about
This is a multinational, open label, single treatment group$1 study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Clovis, California
- Los Angeles, California
- New Orleans, Louisiana
- Boston, Massachusetts
- Danvers, Massachusetts
- Ann Arbor, Michigan
- Rochester, Minnesota
- Albany, New York
- The Bronx, New York
- Portland, Oregon
- Ogden, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations