44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details
臨床試験数 : 98 / 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81
| 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 | NCT05263934 (ClinicalTrials.gov) | July 14, 2022 | 28/2/2022 | 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 | Eosinophilic Granulomatosis With Polyangiitis | Biological: Depemokimab;Biological: Mepolizumab;Drug: Placebo matching mepolizumab;Drug: Placebo matching depemokimab | GlaxoSmithKline | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | United States;Austria;Belgium;Canada;China;Czechia;France;Hungary;Italy;Japan;Korea, Republic of;Spain |
| 3 | 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 | ||
| 4 | JPRN-jRCT2031220070 | 01/07/2022 | 19/05/2022 | 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 | Eosinophilic granulomatosis with polyangiitis for which Standard of care is insufficient. | depemokimab Arm: 200 mg depemokimab administered as 2x100 mg SC injections every 26 weeks and mepolizumab administered as placebo SC injections every 4 weeks. mepolizumab Arm: 300 mg mepolizumab administered as 3x100 mg SC injections every 4 weeks and depemokimab administered as placebo SC injections every 26 weeks | Fujii Katsuya | NULL | Recruiting | >= 18age old | Not applicable | Both | 9 | Phase 3 | Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Mexico;Netherlands;Poland;Portugal;South Korea;Spain;Sweden;United kingdom;USA;Japan |
| 5 | 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 |