45. 好酸球性多発血管炎性肉芽腫症 Eosinophilic granulomatosis with Polyangiitis Clinical trials / Disease details
臨床試験数 : 31 / 薬物数 : 44 - (DrugBank : 18) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 101
| 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 | EUCTR2021-005726-15-NL (EUCTR) | 02/12/2022 | 15/09/2022 | A study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) | A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy - OCEAN | Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy MedDRA version: 20.0;Level: PT;Classification code 10078117;Term: Eosinophilic granulomatosis with polyangiitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Depemokimab Product Code: GSK3511294 INN or Proposed INN: Depemokimab Trade Name: Nucala Product Name: Mepolizumab INN or Proposed INN: Mepolizumab Other descriptive name: Anti-interleukin 5 (IL-5) humanized monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Czechia;Finland;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2021-005726-15-HU (EUCTR) | 12/07/2022 | 24/05/2022 | A study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) | A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy - OCEAN | Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy MedDRA version: 20.0;Level: PT;Classification code 10078117;Term: Eosinophilic granulomatosis with polyangiitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Depemokimab Product Code: GSK3511294 INN or Proposed INN: Depemokimab Trade Name: Nucala Product Name: Mepolizumab INN or Proposed INN: Mepolizumab Other descriptive name: Anti-interleukin 5 (IL-5) humanized monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Czechia;Finland;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2021-005726-15-ES (EUCTR) | 17/05/2022 | 04/03/2022 | A study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) | A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy - OCEAN | Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy MedDRA version: 20.0;Level: PT;Classification code 10078117;Term: Eosinophilic granulomatosis with polyangiitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Depemokimab Product Code: GSK3511294 INN or Proposed INN: Depemokimab Trade Name: Nucala Product Name: Mepolizumab INN or Proposed INN: Mepolizumab Other descriptive name: Anti-interleukin 5 (IL-5) humanized monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Czechia;Finland;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Belgium;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of |