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An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients Aged 4 to 11 Years With Activated Phosphoinositide 3-Kinase Delta Syndrome Followed by an Open-label Long-term Extension

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Trial Profile

An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients Aged 4 to 11 Years With Activated Phosphoinositide 3-Kinase Delta Syndrome Followed by an Open-label Long-term Extension

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

Latest Information Update: 02 May 2025

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At a glance

  • Drugs Leniolisib (Primary)
  • Indications Immunodeficiency disorders
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Pharming Group NV

Most Recent Events

  • 25 Apr 2025 According to Pharming Group NV media release, company will present data from this study at the 2025 Annual Meeting of the Clinical Immunology Society (CIS), taking place May 1-4, 2025 in Philadelphia, PA.
  • 11 Dec 2024 According to Pharming Group NV media release, company look forward to initiating regulatory filings for these younger pediatric patients in 2025.
  • 11 Dec 2024 According to Pharming Group NV media release, company announced positive topline results of data from its Phase III clinical trial evaluating leniolisib in children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome.

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