4 completed, 3 active not recruiting, 1 terminated, 1 unknown. 6 Phase 2, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 4, Active not recruiting 1, Terminated 1 |
| Phase 3 | 5 | Active not recruiting 2, Completed 1, Terminated 1, Unknown 1 |
Follow leniolisib: new trials by email Literature Review of leniolisib trials Research Report on leniolisib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation Leniolisib - PIDs Linked to PI3K | Phase 2 | Active not recruiting | Pharming Technologies B.V. | 12 | 2025-04-29 | 2026-09-16 |
| Leniolisib for Immune Dysregulation in CVID Leniolisib - Common Variable Immunodeficiency (CVID) | Phase 2 | Completed | Pharming Technologies B.V. | 27 | 2025-02-12 | 2026-09-18 |
| Leniolisib for Immune Dysregulation in PIDs Leniolisib - Primary Immunodeficiency Disorders (PIDs) | Phase 2 | Completed | Pharming Technologies B.V. | 13 | 2024-10-21 | 2026-10-19 |
| Pediatric Patients Aged 1 to 6 Years With APDS Leniolisib - APDS | Phase 3 | Active not recruiting | Pharming Technologies B.V. | 16 | 2023-08-30 | 2026-06-15 |
| An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDS Leniolisib - APDS Gene Mutation | Phase 3 | Unknown | Pharming Technologies B.V. | 3 | 2023-08-03 | 2024-02-08 |
| Pediatric Patients Aged 4 to 11 Years With APDS Leniolisib - APDS | Phase 3 | Active not recruiting | Pharming Technologies B.V. | 15 | 2023-02-01 | 2026-05-06 |
| Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI CDZ173 - Activated PI3Kdelta Syndrome (APDS); PASLI Disease | Phase 2 / Phase 3 | Terminated | Pharming Technologies B.V. | 37 | 2016-09-08 | 2026-03-30 |
| Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome CDZ173, Placebo - Primary Sjögren's Syndrome | Phase 2 | Completed | Novartis Pharmaceuticals | 30 | 2016-06-01 | 2021-01-05 |
| Study of Efficacy of CDZ173 in Patients With APDS/PASLI CDZ173, Placebo - Common Variable Immunodeficiency (CVID), APDS / PASLI | Phase 2 / Phase 3 | Completed | Novartis Pharmaceuticals | 37 | 2015-08-24 | 2022-08-10 |
Activated PI3K-delta Syndrome (2) · Common Variable Immunodeficiency (2) · Immunologic Deficiency Syndromes (1) · Lymphadenopathy (1) · Primary Immunodeficiency Diseases (1)
Pharming Technologies B.V. (7) · Novartis Pharmaceuticals (2)
United States (7) · United Kingdom (4) · Germany (3) · Japan (3) · Spain (3) · Belarus (2) · Czechia (2) · Italy (2) · Netherlands (2) · Russia (2) · France (1) · Hungary (1) · Ireland (1) · Portugal (1)
Gulbu Uzel, M.D. (1) · Hirokazu Kanegane, Prof. (1) · Koneti V Rao, MD (1) · Virgil Dalm, MD (1)
PMID 28972011, PMID 36399712, PMID 37797893, PMID 38593221, PMID 41091701, PMID 41608120
2014 (2), 2016 (1)