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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)

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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: 20 Nov 2025

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At a glance

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

Most Recent Events

  • 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.
  • 29 Aug 2025 According to a Sanofi media release, company announced that the US Food and Drug Administration (FDA) has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

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