97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


臨床試験数 : 2,527 薬物数 : 1,468 - (DrugBank : 259) / 標的遺伝子数 : 143 - 標的パスウェイ数 : 201

  
19 trials found
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2021-001644-10-HU
(EUCTR)
04/02/202215/12/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE 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
180Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of
2JPRN-jRCT2011210047
22/12/202129/10/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis - EXPEDITION OLE Ulcerative ColitisCompleters in the lead-in study will receive a maintenance dose of brazikumab 240 mg
administered SC every 4 weeks (Group A). The 240 mg SC dose of brazikumab will be
administered to all responders/completers in the lead-in study regardless of the prior treatment
administered. Participants in the lead-in study who have not responded to treatment and have
met criteria for rescue treatment are considered inadequate/non-responders (Group B). In
these eligible participants, IV induction dosing with 1440 mg of brazikumab at Week 0, Week
4, and Week 8 will be administered, followed by brazikumab 240 mg SC-administered every 4
weeks thereafter (up to Week 52).
Hibi KazushigeNULLPending>= 18age old<= 80age oldBoth21Phase 2India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan
3EUCTR2021-001644-10-IT
(EUCTR)
21/12/202117/09/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis(EXPEDITION OLE) - EXPEDITION OLE 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: ( L ) ASCORBATO DI CALCIO
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: ( 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
180Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of
4EUCTR2021-001644-10-ES
(EUCTR)
30/11/202112/08/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) - EXPEDITION OLE 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
180Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of
5EUCTR2018-001605-93-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
6JPRN-jRCT2011210030
14/09/202130/08/2021Phase 2 Dose-finding UC StudyA 54-Week, Multicenter, Randomized, Double-blind, Placebocontrolled, 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 Ulcerative Colitis, Colitis, Ulcerative, IBD- Brazikumab low dose: IV brazikumab 720 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10

- Brazikumab high-dose: IV brazikumab 1440 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10

- Placebo: IV placebo at Week 0 (Day 1), Week 2, and Week 6 followed by SC placebo every 4 weeks beginning at Week 10
Hibi KazushigeNULLRecruiting>= 18age old<= 80age oldBoth21Phase 2India;South Africa;South Korea;Taiwan;Canada;United States;Czech Republic;France;Germany;Austria;Hungary;Israel;Italy;Poland;Russia;Spain;Ukraine;United Kingdom;Japan
7EUCTR2018-001605-93-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
8EUCTR2018-001605-93-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
9NCT04277546
(ClinicalTrials.gov)
March 3, 202018/2/2020Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)Ulcerative ColitisDrug: Brazikumab Maintenance Dose;Drug: Brazikumab Induction DoseAstraZenecaNULLEnrolling by invitation18 Years80 YearsAll165Phase 2United States;Austria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Bulgaria;Romania
10EUCTR2018-001605-93-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
11EUCTR2018-001605-93-RO
(EUCTR)
10/10/201915/03/2022An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - 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: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
900Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
12EUCTR2018-001605-93-BG
(EUCTR)
09/10/201920/09/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - 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: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
13EUCTR2018-001605-93-IT
(EUCTR)
26/09/201929/01/2021An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Product Name: Brazikumab
Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Product Name: Brazikumab
Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFU
ALLERGAN LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
375Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
14EUCTR2018-001605-93-BE
(EUCTR)
23/09/201907/06/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2b 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: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
15EUCTR2018-001605-93-FR
(EUCTR)
13/09/201925/06/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - 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: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
900 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
16EUCTR2018-001605-93-ES
(EUCTR)
07/08/201909/08/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - 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: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Allergan Ltd.NULLNot RecruitingFemale: yes
Male: yes
900Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
17EUCTR2018-001605-93-GB
(EUCTR)
01/07/201904/04/2019An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - 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: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
375Phase 2United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
18NCT04718818
(ClinicalTrials.gov)
August 7, 201819/1/2021An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisA 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative ColitisUlcerative ColitisDrug: Brazikumab;Drug: Vedolizumab;Drug: PlaceboAstraZenecaNULLRecruiting18 Years80 YearsAll225Phase 2United States;Canada;India;Korea, Republic of;Puerto Rico;Romania;Taiwan
19NCT03616821
(ClinicalTrials.gov)
August 7, 20181/8/2018Placebo-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)Ulcerative Colitis;IBDDrug: Brazikumab;Drug: PlaceboAstraZenecaNULLRecruiting18 Years80 YearsAll256Phase 2United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom