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An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) with APDS (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 1 to 6 Years) with APDS (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: 28 Apr 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

  • 23 Apr 2025 Status changed from recruiting to active, no longer recruiting.
  • 17 Dec 2024 Planned End Date changed from 28 Nov 2025 to 28 Feb 2026.
  • 01 Aug 2024 According to Pharming Group NV media release, the Company anticipate completion of this trial in 2024.

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