Benralizumab (DrugBank: Benralizumab)
4 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 | 6 |
| 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 | 8 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 1 |
| 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 | JPRN-JapicCTI-195049 | 24/12/2019 | 26/11/2019 | MANDARA | 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 Granulomatous Vasculitis | Intervention name : Biological: Benralizumab, Biological: Placebo to Mepolizumab INN of the intervention : - Dosage And administration of the intervention : 1x benralizumab SC injection + 3x placebo to mepolizumab SC injections Control intervention name : Biological: Mepolizumab, Biological: Placebo to Benralizumab INN of the control intervention : - Dosage And administration of the control intervention : 3x mepolizumab SC injections + 1x placebo to benralizumab SC injection | AstraZeneca KK | NULL | recruiting | 18 | BOTH | 6 | Phase 3 | Japan, North America, Europe | |
| 3 | 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 | ||
| 4 | NCT04157348 (ClinicalTrials.gov) | October 29, 2019 | 29/9/2019 | 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 Granulomatous Vasculitis | Biological: Benralizumab;Biological: Mepolizumab;Biological: Placebo to Mepolizumab;Biological: Placebo to Benralizumab | AstraZeneca | NULL | Recruiting | 18 Years | 130 Years | All | 140 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom |
| 5 | 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 |
| 6 | NCT03010436 (ClinicalTrials.gov) | April 15, 2017 | 11/12/2016 | Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study | The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE | Asthma | Drug: Benralizumab | National Jewish Health | AstraZeneca | Recruiting | 18 Years | 100 Years | All | 10 | Phase 2 | United States |
| 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 | JPRN-jRCT2061200026 | 22/09/2020 | 04/11/2020 | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis | The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. - MESSINA | Eosinophilic Esophagitis D3255C00001 | Biological: Benralizumab Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume. Biological: Matching placebo Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume | Hibi Kazushige | NULL | Recruiting | >= 12age old | <= 65age old | Both | 170 | Phase 3 | Canada;France;Germany;Israel;Italy;Netherlands;Poland;Russia;Spain;UK;US;Japan |
| 2 | NCT04543409 (ClinicalTrials.gov) | September 22, 2020 | 18/8/2020 | 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 | Eosinophilic Esophagitis | Biological: Benralizumab;Biological: Matching placebo | AstraZeneca | NULL | Recruiting | 12 Years | 65 Years | All | 170 | Phase 3 | Canada;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom;United States |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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-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 | ||
| 7 | 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 | ||
| 8 | 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 |
| 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 | NCT04612790 (ClinicalTrials.gov) | November 3, 2020 | 12/10/2020 | A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. | A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients With Bullous Pemphigoid (FJORD) | Bullous Pemphigoid | Biological: Benralizumab;Biological: Placebo | AstraZeneca | NULL | Not yet recruiting | 18 Years | 130 Years | All | 120 | Phase 3 | United States;Bulgaria;Germany;Italy |