Anti-interleukin 5 (IL-5) humanized monoclonal ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
44多発血管炎性肉芽腫症3
45好酸球性多発血管炎性肉芽腫症3

44. 多発血管炎性肉芽腫症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-005726-15-NL
(EUCTR)
02/12/202215/09/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
2EUCTR2021-005726-15-HU
(EUCTR)
12/07/202224/05/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
3EUCTR2021-005726-15-ES
(EUCTR)
17/05/202204/03/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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

45. 好酸球性多発血管炎性肉芽腫症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-005726-15-NL
(EUCTR)
02/12/202215/09/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
2EUCTR2021-005726-15-HU
(EUCTR)
12/07/202224/05/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
3EUCTR2021-005726-15-ES
(EUCTR)
17/05/202204/03/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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