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A Study to Assess Safety and Tolerability, and Explore Efficacy of Leniolisib for Immune Dysregulation in Primary Immunodeficiency Disorders

Trial Profile

A Study to Assess Safety and Tolerability, and Explore Efficacy of Leniolisib for Immune Dysregulation in Primary Immunodeficiency Disorders

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Leniolisib (Primary)
  • Indications Immunodeficiency disorders; Primary immunodeficiency diseases
  • Focus Adverse reactions; Proof of concept
  • Sponsors Pharming Group NV

Most Recent Events

  • 20 Mar 2025 According to Pharming Group media release, lead investigator for the Phase II study is Jocelyn Farmer, M.D./PhD, Director of the Clinical Immunodeficiency Program of Beth Israel Lahey Health.
  • 20 Mar 2025 According to Pharming Group media release, company announced that the first patient has been dosed in a Phase II, proof of concept, clinical trial evaluating leniolisib in common variable immunodeficiency (CVID) patients with immune dysregulation.
  • 12 Nov 2024 Planned End Date changed from 1 Nov 2025 to 1 Oct 2025.

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