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Leniolisib in Pediatric Patients With APDS
NCT05438407Phase 3Active, not recruiting
- Sponsor
- Pharming Group
- Start
- Feb 2023
- Primary completion
- Nov 2026
- Modality
- Small Molecules
- Countries
- 3
01
Overview
Phase 3, open-label, single-arm trial of leniolisib in activated phosphoinositide 3-kinase delta syndrome (APDS), sponsored by Pharming Group. Primary endpoints: Number of Participants with Treatment-emergent adverse events, Serious Adverse Events, and Adverse Events at 1 year, Change from baseline in clinical laboratory test results at 1 year and 6 more. Started Feb 2023; status: active, not recruiting.
02
Drugs
leniolisib
03
Conditions
activated phosphoinositide 3-kinase delta syndrome (APDS)
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