Cdz173 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 53 | シェーグレン症候群 | 4 |
| 65 | 原発性免疫不全症候群 | 4 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2014-004616-12-PL (EUCTR) | 21/11/2016 | 12/10/2016 | Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173 | A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome | Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Hungary;Poland;Germany | ||
| 2 | EUCTR2014-004616-12-HU (EUCTR) | 28/09/2016 | 17/08/2016 | Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173 | A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome | Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Hungary;Poland;Germany | ||
| 3 | NCT02775916 (ClinicalTrials.gov) | June 1, 2016 | 16/5/2016 | Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome | A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CDZ173 in Patients With Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: CDZ173;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 30 | Phase 2 | Germany;Hungary |
| 4 | EUCTR2014-004616-12-DE (EUCTR) | 20/05/2016 | 17/03/2016 | Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173 | A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome | Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Hungary;Poland;Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-000468-41-GB (EUCTR) | 25/02/2019 | 12/03/2018 | Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLI | An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patientswith APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI | APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Leniolisib Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 Product Name: Leniolisib Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2;Phase 3 | United States;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 2 | EUCTR2016-000468-41-IE (EUCTR) | 25/10/2018 | 27/02/2018 | Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLI | An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI | APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Leniolisib Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 Product Name: Leniolisib Product Code: CDZ173 INN or Proposed INN: leniolisib | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2;Phase 3 | United States;France;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2016-000468-41-CZ (EUCTR) | 19/07/2016 | 25/05/2016 | Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLI | An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) - Extension to the study of efficacy of CDZ173 in patients with APDS/PASLI | APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency) MedDRA version: 20.0;Level: PT;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Leniolisib Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 Product Name: Leniolisib Product Code: CDZ173 INN or Proposed INN: leniolisib | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2;Phase 3 | United States;France;Belarus;Czechia;Czech Republic;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | NCT02435173 (ClinicalTrials.gov) | August 24, 2015 | 24/2/2015 | Study of Efficacy of CDZ173 in Patients With APDS/PASLI | An Open-label, Non-randomized, Within-patient Dose-finding Study Followed by a Randomized, Subject, Investigator and Sponsor-blinded Placebo Controlled Study to Assess the Efficacy and Safety of CDZ173 in Patients With APDS/PASLI | Common Variable Immunodeficiency (CVID) More Specifically Activated PI3Kdelta Syndrome (APDS) p110delta-activating Mutation Causing Senescent T Cells;Lymphadenopathy and Immunodeficiency (PASLI) | Drug: CDZ173 | Novartis Pharmaceuticals | NULL | Recruiting | 12 Years | 75 Years | All | 36 | Phase 2;Phase 3 | United States;Belarus;Czechia;Ireland;Italy;Netherlands;Russian Federation;United Kingdom;Czech Republic |