drugset / Trial / NCT06897358

Leniolisib for Immune Dysregulation in CVID

NCT06897358 ↗

Phase 2 Active not recruiting 20 enrolled Pharming Technologies B.V. Lahey Hospital & Medical Center · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-02-12
Primary completion
2026-10
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Leniolisib Small molecule 70 mg —