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 | 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 | NCT05353179 (ClinicalTrials.gov) | June 2022 | 11/4/2022 | Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers | Phase I, Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of Pharmacokinetic and Safety Similarities Between Meperizumab Injection and NUCALA® in Healthy Male Volunteers | Granulomatosis With Polyangiitis;Hemophagocytic Syndrome | Drug: Meperizumab injection;Drug: NUCALA® | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | NULL | Not yet recruiting | 18 Years | 55 Years | Male | 88 | Early Phase 1 | China |
| 4 | 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 | ||
| 5 | EUCTR2019-001832-77-IT (EUCTR) | 25/02/2020 | 15/06/2021 | A study to evaluate if benralizumab compared to mepolizumab may be beneficial in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy - NA | Eosinophilic Granulomatosis with Polyangiitis (EGPA) MedDRA version: 20.1;Level: LLT;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: NUCALA Product Name: mepolizumab Product Code: [L04AC06] INN or Proposed INN: Mepolizumab Product Name: benralizumab Product Code: [MEDI-563] INN or Proposed INN: benralizumab | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy | ||
| 6 | EUCTR2019-001832-77-DE (EUCTR) | 15/01/2020 | 21/08/2019 | Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab. | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy | Eosinophilic Granulomatosis with Polyangiitis (EGPA) MedDRA version: 20.1;Level: LLT;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: Benralizumab Trade Name: Nucala 100 mg powder for solution for injection Product Name: mepolizumab Product Code: L04AC06 INN or Proposed INN: Mepolizumab Other descriptive name: Nucala | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Canada;Belgium;Israel;Germany;United Kingdom;Italy;Japan | ||
| 7 | EUCTR2019-001832-77-FR (EUCTR) | 23/12/2019 | 02/08/2019 | A study to evaluate if benralizumab compared to mepolizumab may be beneficial in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy | Eosinophilic Granulomatosis with Polyangiitis (EGPA);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: Benralizumab Trade Name: NUCALA Product Name: mepolizumab Product Code: L04AC06 INN or Proposed INN: Mepolizumab Other descriptive name: Nucala | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom | ||
| 8 | EUCTR2019-001832-77-GB (EUCTR) | 20/08/2019 | 22/10/2020 | Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab. | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy. | Eosinophilic Granulomatosis with Polyangiitis (EGPA);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: Benralizumab Trade Name: NUCALA Product Name: NUCALA Product Code: L04AC06 INN or Proposed INN: Mepolizumab Other descriptive name: Nucala | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom | ||
| 9 | EUCTR2012-004385-17-GB (EUCTR) | 12/12/2013 | 30/10/2013 | Study of mepolizumab versus placebo in addition to standard of care for the treatment of Eosinophilic Granulomatosis with Polyangiitis. | A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. | Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. MedDRA version: 19.0;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 19.0;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 19.0;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 19.0;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 19.0;Classification code 10056218;Term: Necrotising granulomatous vasculitis;Classification code 10036023;Term: Polyangiitis;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Nucala Product Name: Mepolizumab Product Code: SB-240563 INN or Proposed INN: Mepolizumab Other descriptive name: Recombinant humanized monoclonal antibody specific for human IL-5 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom |