Also referred to as MEDI2070 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病4
97潰瘍性大腸炎4

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001866-14-IT
(EUCTR)
21/12/202112/10/2021Open-label Extension Study of Brazikumab in Crohn's DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE) - INTREPID OLE Moderately to Severely Active Crohn's Disease.
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
2EUCTR2019-001866-14-HU
(EUCTR)
09/11/202102/08/2021Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
3EUCTR2019-001866-14-PL
(EUCTR)
27/09/202108/09/2021Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
4EUCTR2019-001866-14-DE
(EUCTR)
10/09/202111/06/2021Open-label Extension Study of Brazikumab in Crohn’s DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) Moderately to Severely Active Crohn’s Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001605-93-HU
(EUCTR)
22/11/202105/05/2020Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of
2EUCTR2018-001605-93-DE
(EUCTR)
20/05/202004/06/2019Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of
3EUCTR2018-001605-93-AT
(EUCTR)
09/03/202007/11/2019Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of
4EUCTR2018-001605-93-CZ
(EUCTR)
21/11/201905/08/2019Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in) - Phase 2 Dose-finding UC Study Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
Product Name: Brazikumab
Product Code: MEDI2070
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Japan;Korea, Republic of