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An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia

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Trial Profile

An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 20 Sep 2024

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At a glance

  • Drugs Rilzabrutinib (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms LUNA 2
  • Sponsors Principia Biopharma

    • Most Recent Events

    • 30 Jan 2024 Planned End Date changed from 1 Dec 2025 to 31 Dec 2025.
    • 12 Dec 2023 Initial Results of part B assessing the durability of response with rilzabrutinib in relapsed ITP patients, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 12 Dec 2023 Results (n=26) assessing effects of rilzabrutinib on bleeding and HRQoL on patients with Immune Thrombocytopenia, presented at the 65th American Society of Hematology Annual Meeting and Exposition

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