Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation

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.

Timeline

Start

2025-04-29

Primary completion

2028-09-18

Completion

2029-04-13

Drugs

Indications