Study of Efficacy of CDZ173 in Patients With APDS/PASLI
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- STATUS
- Recruiting
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- End date
- Jun 8, 2021
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- participants needed
- 36
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- sponsor
- Novartis Pharmaceuticals
Novartis Pharmaceuticals
Primary Contact
National Institute of Health NIH (9.6 mi away) Contact
+9 other locationSummary
This study is designed to explore CDZ173, a selective PI3K inhibitor, in patients with genetically activated PI3K, i.e., patients with APDS/PASLI. The study consists of two parts. Part I is 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 is designed to assess efficacy and safety of CDZ173 in this population.
Description
This study is designed to explore CDZ173, a selective PI3K inhibitor, in patients with genetically activated PI3K, i.e., patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)I.
The study consists of two parts. Part I is 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 is designed to assess efficacy and safety of CDZ173 in this population.
Details
| Condition | Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome APDS p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency PASLI, Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome APDS p110delta-activating Mutation Causing Senescent T Cells, Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome APDS p110delta-activating Mutation Causing Senescent T Cells, Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome APDS p110delta-activating Mutation Causing Senescent T Cells, Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI), Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells, Lymphadenopathy and Immunodeficiency (PASLI) |
|---|---|
| Treatment | CDZ173 |
| Clinical Study Identifier | NCT02435173 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 3 March 2021 |
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