Rilzabrutinib for Immune Thrombocytopenia
(LUNA 3 Trial)

Recruiting in Palo Alto (17 mi)

+272 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Principia Biopharma, a Sanofi Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests rilzabrutinib, a drug that may help people with chronic ITP who have very low platelet counts. The drug works by blocking a substance that causes the immune system to destroy platelets. Participants will take the drug for several months to see if it helps increase their platelet levels.

Research Team

Eligibility Criteria

Adults and adolescents with persistent or chronic immune thrombocytopenia (ITP) who have a very low platelet count are eligible for this trial. They must not be pregnant, planning surgery soon, or have had certain treatments like blood transfusions recently. Participants need to agree to use contraception and cannot have other health conditions that might interfere with the study.

Inclusion Criteria

My child needs treatment for ITP as decided by our doctor.

All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Your blood platelet count has been consistently low, and no single platelet count has been higher than 35,000/µL in the last 14 days before starting the study drug.

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Exclusion Criteria

Pregnant or lactating women

I haven't changed my CS or TPO-RA dose significantly in the last 14 days.

I am scheduled for surgery during the treatment period.

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Treatment Details

Interventions

Placebo (Other)
Rilzabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial OverviewThe trial is testing Rilzabrutinib, a potential new treatment for ITP. Patients will either receive Rilzabrutinib or a placebo twice daily over several weeks to see if it helps increase their platelet counts compared to no active treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RilzabrutinibExperimental Treatment1 Intervention

Patients receive rilzabrutinib 400mg orally twice daily for up to 24 weeks followed by 28 weeks of open label period

Group II: PlaceboPlacebo Group1 Intervention

Patients receive matching placebo 400mg orally twice daily for up to 24 weeks