Status: Recruiting
Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation
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.
Participants needed: 12
Trial details
Phase: Phase 2Age: 12-75Biological sex: AllType: InterventionalSponsor: Pharming Technologies B.V.Updated: Feb 13, 2026Locations: 4
Eligibility criteria
Subject must have participated in LE 7201. [+2]
Subject has had a successful allogeneic hematopoietic stem cell transplant. [+28]