CDZ173

DRUG3 trials

Sponsors

Novartis Pharmaceuticals, Pharming Technologies B.V.

Conditions

Activated PI3Kdelta Syndrome (APDS); PASLI DiseaseCommon Variable Immunodeficiency (CVID), APDS / PASLIPrimary Sjögren's Syndrome

Phase 2

Study of Efficacy of CDZ173 in Patients With APDS/PASLI

CompletedNCT02435173

Novartis PharmaceuticalsCommon Variable Immunodeficiency (CVID), APDS / PASLI

Start: 2015-08-24End: 2021-08-16Updated: 2022-08-10

Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

CompletedNCT02775916

Novartis PharmaceuticalsPrimary Sjögren's Syndrome

Start: 2016-06-01End: 2017-05-17Updated: 2021-01-05

Extension to the Study of Efficacy of CDZ173 in Patients With APDS/PASLI

TerminatedNCT02859727

Pharming Technologies B.V.Activated PI3Kdelta Syndrome (APDS); PASLI Disease

Start: 2016-09-08End: 2025-01-30Updated: 2026-03-30

Related Papers

Leniolisib, a Selective Phosphoinositide 3-Kinase Delta (PI3Kδ) Inhibitor, in Japanese Patients Aged 12 and Over with Activated PI3Kδ Syndrome (APDS): Data from a 12-Week, Open-Label, Single-Arm Study

Journal of Human Immunity2026-06-04

Evaluating the impact of leniolisib treatment on symptoms and health-related quality of life in activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome

Frontiers in Immunology2026-05-07

Key outcomes in treatment of activated phosphoinositide 3-kinase delta syndrome: An e-Delphi panel study and responder threshold application.

2025-10-15

Lymphoma in Patients with Activated Phosphoinositide 3-kinase δ Syndrome Enrolled in Targeted PI3Kδ Inhibitor (Leniolisib) Clinical Trial

Journal of Human Immunity2025-04-25

Comparative efficacy of leniolisib (CDZ173) versus standard of care on rates of respiratory tract infection and serum immunoglobulin M (IgM) levels among individuals with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS): an externally controlled study

Clinical & Experimental Immunology2024-12-021 citations

Leniolisib treatment for people with activated PI3K delta syndrome (APDS): a plain language summary of the phase 3 study

Future Rare Diseases2024-08-21

Long-term treatment with selective PI3Kδ inhibitor leniolisib in adults with activated PI3Kδ syndrome

Blood Advances2024-04-0911 citations

Interim analysis: Open-label extension study of leniolisib for patients with APDS

Journal of Allergy and Clinical Immunology2023-10-0429 citations

A randomized, placebo-controlled phase 3 trial of the PI3Kδ inhibitor leniolisib for activated PI3Kδ syndrome

Blood2022-11-18108 citations

Interim Analysis of Safety and Hematological Parameters of an Ongoing Long-Term Open-Label Extension Study of Investigational PI3Kδ Inhibitor Leniolisib for Patients with Activated PI3K Delta Syndrome (APDS) through December 2021

Blood2022-11-156 citations

Safety and Efficacy of Long Term Suppression of PI3Kinase Pathway By Small Molecule PI3K-Delta Inhibitor, Leniolisib in Apds (Activated PI3Kδ Syndrome)

Blood2018-11-297 citations

Effective “activated PI3Kδ syndrome”–targeted therapy with the PI3Kδ inhibitor leniolisib

Blood2017-10-02276 citations