Benralizumab ( DrugBank: Benralizumab )
5 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 | 7 |
| 45 | 好酸球性多発血管炎性肉芽腫症 | 4 |
| 98 | 好酸球性消化管疾患 | 11 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 7 |
| 299 | 嚢胞性線維症 | 4 |
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. | 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-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 | ||
| 2 | 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 | ||
| 3 | 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 | |
| 4 | 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 | ||
| 5 | 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 | Active, not recruiting | 18 Years | 130 Years | All | 140 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom |
| 6 | 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 | ||
| 7 | 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 | Active, not recruiting | 18 Years | 100 Years | All | 10 | Phase 2 | United States |
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. | 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-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 | ||
| 2 | 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 | ||
| 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 | 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 |
98. 好酸球性消化管疾患
臨床試験数 : 172 / 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135
| 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-jRCT2031210500 | 18/01/2022 | 18/12/2021 | Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (HUDSON GI) | A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) - HUDSON GI | Eosinophilic gastritis, Eosinophilic gastroenteritis | The patients are planned to be randomly assigned to receive either a fixed SC dose of Benralizumab or placebo once monthly in a 24 week double-blind period followed by assessments during an open-label Benralizumab treatment period. | Hibi Kazushige | NULL | Recruiting | >= 12age old | <= 130age old | Both | 230 | Phase 3 | Australia;China;Vietnam;Italy;France;Poland;Spain;Brazil;Canada;America;Netherlands;Ukraine;Israel;Japan |
| 2 | NCT05251909 (ClinicalTrials.gov) | January 18, 2022 | 6/8/2021 | Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) | A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) | Eosinophilic Gastritis;Eosinophilic Gastroenteritis | Biological: Benralizumab;Biological: Placebo | AstraZeneca | NULL | Active, not recruiting | 12 Years | 130 Years | All | 12 | Phase 3 | United States;Brazil;Canada;France;Italy;Japan;Netherlands;Poland;Spain;Ukraine;Vietnam;Australia;China;Germany;Mexico |
| 3 | JPRN-jRCT2061200026 | 16/12/2020 | 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. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments. - 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 | Not Recruiting | >= 12age old | <= 65age old | Both | 170 | Phase 3 | Canada;France;Germany;Israel;Italy;Netherlands;Poland;Russia;Spain;UK;US;Japan |
| 4 | 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 | Terminated | 12 Years | 65 Years | All | 211 | Phase 3 | United States;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 5 | 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 | ||
| 6 | EUCTR2019-002871-32-IT (EUCTR) | 11/05/2020 | 31/08/2021 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebocontrolled 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: Diseases [C] - Digestive System Diseases [C06] | 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 | 170 | Phase 3 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 7 | 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 | Trade Name: Fasenra 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 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan | ||
| 8 | 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 | Trade Name: Fasenra 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 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy;Japan | ||
| 9 | 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 | ||
| 10 | 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 | Germany;Spain;Canada;Netherlands;Russian Federation;United States;Poland;Italy;United Kingdom;Israel;France | ||
| 11 | 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 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan |
162. 類天疱瘡（後天性表皮水疱症を含む。）
臨床試験数 : 90 / 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
| 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 | EUCTR2020-000287-32-GR (EUCTR) | 04/11/2021 | 13/09/2021 | 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) - FJORD | Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Fasenra 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 | 120 | Phase 3 | France;United States;Greece;Spain;Australia;Bulgaria;Israel;Germany;United Kingdom;Italy;Japan;China | ||
| 2 | EUCTR2020-000287-32-DE (EUCTR) | 12/04/2021 | 16/10/2020 | 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) - FJORD | Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Fasenra 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 | 120 | Phase 3 | United States;France;Greece;Spain;Australia;Israel;Bulgaria;Germany;Japan;Italy;China | ||
| 3 | NCT04612790 (ClinicalTrials.gov) | March 31, 2021 | 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 | Recruiting | 18 Years | 130 Years | All | 120 | Phase 3 | United States;Australia;Bulgaria;China;France;Germany;Greece;Israel;Italy;Japan;Spain |
| 4 | JPRN-jRCT2071210014 | 26/03/2021 | 26/04/2021 | 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. | The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP). - FJORD | Bullous Pemphigoid | This study is designed to assess the efficacy and safety of a benralizumab 60 mg loading dose followed by repeat dosing of subcutaneously (SC) administered benralizumab 30 mg versus placebo in adult participants with symptomatic BP. Following screening, about 120 eligible participants will be randomized 1:1 to receive either benralizumab or placebo. Double-blind treatment period (0w-36w): In the benralizumab group, 60 mg initially and 30 mg thereafter are subcutaneously administered every 4 weeks. In the placebo group, placebo is subcutaneously administered every 4 weeks. Open-label extension period (36w-): All participants who complete the double-blind dosing period will be given the option of receiving benralizumab 30 mg subcutaneously every 4 weeks. | Hibi Kazushige | NULL | Recruiting | >= 18age old | Not applicable | Both | 12 | Phase 3 | United States;Australia;Bulgaria;France;Germany;Israel;Italy;Spain;Japan |
| 5 | EUCTR2020-000287-32-FR (EUCTR) | 09/02/2021 | 03/11/2020 | 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 MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | 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 | 120 | Phase 3 | United States;France;Spain;Australia;Israel;Bulgaria;Germany;Japan;Italy | ||
| 6 | EUCTR2020-000287-32-IT (EUCTR) | 22/01/2021 | 24/05/2021 | 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 MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | 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 | 120 | Phase 3 | France;United States;Spain;Australia;Bulgaria;Israel;Germany;Japan;Italy | ||
| 7 | EUCTR2020-000287-32-BG (EUCTR) | 02/12/2020 | 06/10/2020 | 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) - FJORD | Bullous Pemphigoid MedDRA version: 21.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Fasenra 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 | 120 | Phase 3 | France;United States;Greece;Spain;Australia;Israel;Bulgaria;Germany;Italy;Japan;China |
299. 嚢胞性線維症
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | NCT05006573 (ClinicalTrials.gov) | July 21, 2021 | 23/6/2021 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) | Non-cystic Fibrosis Bronchiectasis | Biological: Benralizumab;Biological: Placebo to Benralizumab | AstraZeneca | NULL | Active, not recruiting | 18 Years | 130 Years | All | 100 | Phase 3 | United States;Argentina;Australia;Canada;China;Denmark;Germany;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Spain;United Kingdom;Vietnam |
| 2 | EUCTR2020-004068-24-IT (EUCTR) | 21/05/2021 | 02/08/2021 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE | Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: NA Product Name: benralizumab Product Code: [MEDI-563] INN or Proposed INN: benralizumab Other descriptive name: benralizumab Product Name: Atropina Product Code: [NA] Product Name: Antistaminici H1 - H2 Product Code: [na] Product Name: C01CA04 - Dopamina Product Code: [na] Product Name: Adrenalina Product Code: [NA] Product Name: Salbutamolo Product Code: [NA] Product Name: H02 - Corticosteroidi Sistemici Product Code: [NA] | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Australia;Denmark;Germany;China;Korea, Republic of | ||
| 3 | EUCTR2020-004068-24-DE (EUCTR) | 06/04/2021 | 21/01/2021 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE | Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;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 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Canada;Argentina;Poland;Viet Nam;Australia;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 4 | EUCTR2020-004068-24-DK (EUCTR) | 15/02/2021 | 22/12/2020 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE | Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;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 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Denmark;Australia;Germany;China;Japan;Korea, Republic of |