Clinical Trial

Leniolisib for Immune Dysregulation in PIDs

Active, Not Recruiting Phase 2
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Summary
This study is an exploratory, non-randomized, open-label, within-patient dose escalation study. The primary objective is to assess safety and tolerability of leniolisib. Secondary objectives include assessments of PK/PD, and to explore clinical efficacy measures with administration of three different dose levels of leniolisib.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-08; most recent amendment 2026-02-10.
Status change: Recruiting → Active, Not Recruiting 2026-02-10
Status change: Not Yet Recruiting → Recruiting 2024-11-08
Trial Details
NCT Number NCT06549114
Lead Sponsor Pharming Technologies B.V.
Conditions Primary Immunodeficiency Disorders (PIDs)
Enrollment 12 participants
Start Date 2024-10-21
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2026-02-13