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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)

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: 01 Jul 2026

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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

  • 23 Jun 2026 According to a Sanofi media release, the Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization to Wayrilz (rilzabrutinib) for the treatment of persistent or chronic immune thrombocytopenia (ITP) in patients who do not respond sufficiently to other treatments or in whom tolerability is considered to be problematic.
  • 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.

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