Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

Next Previous
Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Rilzabrutinib (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Acronyms LUNA3
  • Sponsors Principia Biopharma

Most Recent Events

  • 23 Dec 2025 According to a Sanofi media release, company announced that the European Commission has approved Wayrilz (rilzabrutinib), as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. This follows the positive opinion by the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP).
  • 17 Oct 2025 According to a Sanofi media release, data from this study were published in Blood.
  • 17 Oct 2025 According to a Sanofi media release, company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Wayrilz (rilzabrutinib) as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. A final decision is expected in the coming months.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top