CDZ173/Leniolisib
Sponsors
Pharming Technologies B.V.
Conditions
Activated Phosphoinositide 3-Kinase Delta SyndromeCommon variable immunodeficiencyprimary immunodeficiency
Phase 1
Phase 2
A study to assess safety and tolerability, and explore efficacy of leniolisib for immune dysregulation in common variable immunodeficiency
RecruitingCTIS2024-517725-93-00
Start: 2025-07-14Target: 6Updated: 2025-11-20
An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of leniolisib for immune dysregulation in patients with primary immunodeficiency
Not yet recruitingCTIS2025-522444-40-00
Target: 6Updated: 2026-01-26
Phase 3
An Open-label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 1 to 6 Years) with APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-label Long-term Extension
Active, not recruitingCTIS2022-502180-38-00
Start: 2024-12-16Target: 4Updated: 2025-11-11
An Open-Label, Single Arm Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Leniolisib in Pediatric Patients (Aged 4 to 11 Years) With APDS (Activated Phosphoinositide 3-Kinase Delta Syndrome) Followed by an Open-Label Long-Term Extension
CompletedCTIS2024-515489-15-00
Start: 2023-09-06End: 2025-06-03Target: 6Updated: 2025-11-12