Clinical Trial

Leniolisib for Immune Dysregulation in CVID

Active, Not Recruiting Phase 2
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Summary
In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. The primary goal is to assess the safety and tolerability of leniolisib, and secondary goal is to assess the potential for leniolisib to provide benefits for patients.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-03-20; most recent amendment 2026-02-10.
Status change: Recruiting → Active, Not Recruiting 2026-02-10
Trial Details
NCT Number NCT06897358
Lead Sponsor Pharming Technologies B.V.
Collaborators: Lahey Hospital & Medical Center
Conditions Common Variable Immunodeficiency (CVID)
Enrollment 20 participants
Start Date 2025-02-12
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-02-12