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Study identifier: NCT06990529 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation

Condition: PIDs Linked to PI3K  ·  Sponsor: Pharming Technologies B.V.

PhasePhase 2
Planned participants12
Who can joinAll sexes, 12 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (4)

National Institute of HealthBethesda, Maryland, United StatesRecruiting
Lahey Hospital & Medical CenterBurlington, Massachusetts, United StatesRecruiting
Mount Sinai HospitalNew York, New York, United StatesRecruiting
IIS La FeValencia, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT06990529