Medi-563 (DrugBank: -)
3 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 |
| 98 | 好酸球性消化管疾患 | 6 |
| 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 | 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] | 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 | United States;France;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy | ||
| 2 | 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 | ||
| 3 | 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 |
| 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 | 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] | 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 | United States;France;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy | ||
| 2 | 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 | ||
| 3 | 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 |
| 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 | EUCTR2019-002871-32-FR (EUCTR) | 06/07/2020 | 11/05/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2019-002871-32-DE (EUCTR) | 09/04/2020 | 27/01/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Japan;Italy | ||
| 3 | EUCTR2019-002871-32-NL (EUCTR) | 02/03/2020 | 08/01/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Spain;Poland;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 4 | EUCTR2019-002871-32-GB (EUCTR) | 24/02/2020 | 18/03/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;Japan;Italy;United Kingdom | ||
| 5 | EUCTR2019-002871-32-ES (EUCTR) | 05/02/2020 | 20/12/2019 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Poland;Spain;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 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 |
| 6 | EUCTR2019-002871-32-PL (EUCTR) | 15/01/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | NA | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy |