Study of Efficacy of CDZ173 in Patients With APDS/PASLI
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Common Variable Immunodeficiency (CVID), APDS / PASLI
In brief
This study was designed to explore CDZ173, a selective PI3Kδ inhibitor, in patients with genetically activated PI3Kδ, i.e., patients with Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency (APDS/PASLI). The study consisted of two parts: Part I was the open label part designed to establish the safety and pharmacokinetics of CDZ173 in the target population, as well as to select the optimal dose to be tested in Part II. Part II was designed to assess efficacy and safety of CDZ173 in the target population.
Key facts
- Study ID
- NCT02435173
- Run by
- Novartis Pharmaceuticals
- People needed
- 37
- Starts
- 2015-08-24
- Expected to finish
- 2021-08-16
- Last updated by the study team
- 2022-08-10
Who can join
Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- National Institute of Health NIH — Bethesda, Maryland, United States
- Novartis Investigative Site — Minsk, Belarus
- Novartis Investigative Site — Prague, Czechia
- Novartis Investigative Site — Dresden, Germany
- Novartis Investigative Site — Dublin, Ireland
- Novartis Investigative Site — Palermo, PA, Italy
- Novartis Investigative Site — Brescia, Italy
- Novartis Investigative Site — Rotterdam, Netherlands
- Novartis Investigative Site — Moscow, Russia
- Novartis Investigative Site — Belfast, United Kingdom
Full record on ClinicalTrials.gov
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