Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-16; most recent amendment 2026-02-10.
Trial Details
NCT Number NCT06990529
Lead Sponsor Pharming Technologies B.V.
Collaborators: Aixial Group
Conditions PIDs Linked to PI3K
Enrollment 12 participants
Start Date 2025-04-29
Primary Completion 2028-09-18 (estimated)
Study Completion 2029-04-13 (estimated)
Updated on ClinicalTrials.gov 2026-02-13