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


臨床試験数 : 171 薬物数 : 184 - (DrugBank : 47) / 標的遺伝子数 : 42 - 標的パスウェイ数 : 141

  
11 trials found
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1NCT05251909
(ClinicalTrials.gov)
January 18, 20226/8/2021Efficacy 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 GastroenteritisBiological: Benralizumab;Biological: PlaceboAstraZenecaNULLRecruiting12 Years130 YearsAll230Phase 3United States;Australia;Brazil;Canada;France;Germany;Italy;Japan;Netherlands;Poland;Spain;Ukraine;Vietnam
2JPRN-jRCT2031210500
14/01/202218/12/2021Efficacy 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 gastroenteritisThe 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 KazushigeNULLRecruiting>= 12age old<= 130age oldBoth230Phase 3Australia;China;Vietnam;Italy;France;Poland;Spain;Brazil;Canada;America;Netherlands;Ukraine;Israel;Japan
3NCT04543409
(ClinicalTrials.gov)
September 22, 202018/8/2020A Study of Benralizumab in Patients With Eosinophilic EsophagitisA Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic EsophagitisEosinophilic EsophagitisBiological: Benralizumab;Biological: Matching placeboAstraZenecaNULLRecruiting12 Years65 YearsAll170Phase 3United States;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom
4JPRN-jRCT2061200026
22/09/202004/11/2020A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic EsophagitisThe 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 KazushigeNULLRecruiting>= 12age old<= 65age oldBoth170Phase 3Canada;France;Germany;Israel;Italy;Netherlands;Poland;Russia;Spain;UK;US;Japan
5EUCTR2019-002871-32-FR
(EUCTR)
06/07/202011/05/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United States;France;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
6EUCTR2019-002871-32-IT
(EUCTR)
11/05/202031/08/2021A Study of Benralizumab in Patients with Eosinophilic EsophagitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
7EUCTR2019-002871-32-DE
(EUCTR)
09/04/202027/01/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan
8EUCTR2019-002871-32-NL
(EUCTR)
02/03/202008/01/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy;Japan
9EUCTR2019-002871-32-GB
(EUCTR)
24/02/202018/03/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United Kingdom;Italy;Japan;Germany;Netherlands;Israel;Russian Federation;Poland;Spain;Canada;France;United States
10EUCTR2019-002871-32-ES
(EUCTR)
05/02/202020/12/2019A Study of Benralizumab in Patients with Eosinophilic EsophagitisA 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United States;France;Canada;Poland;Spain;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
11EUCTR2019-002871-32-PL
(EUCTR)
15/01/2020A Study of Benralizumab in Patients with Eosinophilic EsophagitisA 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 ABNULLNAFemale: yes
Male: yes
170Phase 3France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan