Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

About the trial

Sponsor

Principia Biopharma, a Sanofi Company

Tested

Rilzabrutinib (drug), Placebo (drug)

Dates

Started 2020-12-14; completion 2026-09-02

Results posted

Yes

This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of \<30,000/μL (and no single platelet count \>35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients received rilzabrutinib or placebo 400mg twice daily. For each patient, the study lasted up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This included Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. For adult participants, the maximum duration of the long-term extension (…

From ClinicalTrials.gov, last updated 2026-10-07. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $260,251 in research payments for this study in 2025 (116 payments).

Products named: Wayrilz

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.