drugset / Trial / NCT06249997
An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDS
Phase 3
Unknown
3 enrolled
Pharming Technologies B.V.
Axial Biotech, Inc · collabCMIC Co, Ltd. Japan · collabLaboratory Corporation of America · collab
NaSingle-groupOpen-labelTreatment
Summary
An Open-Label, Non-Randomized Study to Assess the Safety and Efficacy of Leniolisib in Japanese Patients With Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Followed By an Open-Label Long-Term Extension. For the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).
Timeline
- Start
- 2023-08-03
- Primary completion
- 2025-01-31
- Completion
- 2025-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leniolisib | Small molecule | 40 mg | — |
| Subject | Leniolisib | Small molecule | 70 mg | — |