clinical trial · NCT06990529
Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
Pharming Technologies B.V.·phase2·recruiting·n = 12
PIDs Linked to PI3KLeniolisib
brief summary
This is an open-label extension (OLE) study to extend treatment to patients with primary immunodeficiency (PID) disorders linked to phosphoinositide 3-kinase delta signaling who participated in a prior study of leniolisib, LE 7201. The primary objective is to assess long-term safety and tolerability of leniolisib. Secondary and exploratory objectives include various efficacy and immunophenotyping measures for leniolisib.
started
Apr 29, 2025
primary completion
Sep 18, 2028
completion
Apr 13, 2029
last updated
Feb 13, 2026
official title
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Leniolisib for Immune Dysregulation in Primary Immunodeficiency Disorders
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol