ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFU ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis4

97. Ulcerative colitis


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2020-004300-34-IT
(EUCTR)
13/10/202130/08/2021A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Ulcerative ColitisA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - NA Moderately to severely active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO
Product Name: Vedolizumab
Product Code: [NA]
INN or Proposed INN: Vedolizumab
Other descriptive name: MLN0002
TAKEDA DEVELOPMENT CENTER AMERICAS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan
2EUCTR2018-001605-93-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
3EUCTR2015-003270-32-IT
(EUCTR)
09/02/201620/03/2019Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s diseaseIdentification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD) - Immunological predictors of therapeutic response to vedolizumab Ulcerative colitis (UC) and Crohn disease (CD)
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO
Product Name: entyvio
INN or Proposed INN: VEDOLIZUMAB
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 4Italy
4EUCTR2015-000939-33-IT
(EUCTR)
24/11/201508/06/2021Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitiscompared to Adalimumab SCA Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO
Product Name: Vedolizumab IV
Product Code: MLN0002
Trade Name: HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 SIRINGA PRERIEMPITA 0.8 ML + 1 TAMPONE IMBEVUTO DI ALCOL IN UN BLISTER
TAKEDA DEVELOPMENT CENTRE EUROPE LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;Serbia;United States;Taiwan;Hong Kong;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany