98. 好酸球性消化管疾患 Eosinophilic gastrointestinal disease Clinical trials / Disease details
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 |