96. Crohn disease
2,209 clinical trials,   1,276 drugs   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways

Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
47 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03196427
(ClinicalTrials.gov)
July 30, 201820/6/2017Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaTakeda Development Center Americas, Inc.;Takeda Development Centre Europe Ltd.Active, not recruiting2 Years17 YearsAll80Phase 2United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom
2EUCTR2017-002231-41-NL
(EUCTR)
14/05/201826/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary
3EUCTR2017-002182-21-NL
(EUCTR)
20/03/201828/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom
4EUCTR2017-002182-21-PL
(EUCTR)
17/01/201813/10/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
5EUCTR2017-002231-41-PL
(EUCTR)
17/01/201813/10/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-002182-21-BE
(EUCTR)
10/01/201814/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
7EUCTR2017-002231-41-BE
(EUCTR)
10/01/201814/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
8EUCTR2017-002182-21-DE
(EUCTR)
18/12/201713/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
9EUCTR2017-002231-41-DE
(EUCTR)
18/12/201714/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
10EUCTR2017-002182-21-FR
(EUCTR)
18/12/201715/12/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-002182-21-GB
(EUCTR)
16/11/201711/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
12EUCTR2017-002231-41-GB
(EUCTR)
15/11/201711/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
13NCT03138655
(ClinicalTrials.gov)
November 8, 201719/4/2017Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: VedolizumabTakedaTakeda Development Center Americas, Inc.;Takeda Development Centre Europe Ltd.Completed2 Years17 YearsAll90Phase 2United States;Belgium;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom
14EUCTR2017-002182-21-HU
(EUCTR)
25/10/201712/09/2017An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
15EUCTR2017-002231-41-HU
(EUCTR)
25/10/201719/09/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03234907
(ClinicalTrials.gov)
August 3, 201726/7/2017Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Vedolizumab IV;Drug: PlaceboTakedaNULLCompleted18 Years80 YearsAll215Phase 3China
17EUCTR2015-000852-12-BE
(EUCTR)
31/07/201724/03/2016Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 18.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
126Phase 4France;United States;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom
18NCT02764762
(ClinicalTrials.gov)
June 12, 20175/5/2016Triple Combination Therapy in High Risk Crohn's Disease (CD)An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing ComplicationsCrohn DiseaseDrug: Vedolizumab;Drug: Adalimumab;Drug: MethotrexateTakedaNULLActive, not recruiting18 Years65 YearsAll55Phase 4United States;Canada
19EUCTR2016-000678-40-BG
(EUCTR)
05/01/201701/11/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLNot RecruitingFemale: yes
Male: yes
385Phase 4Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Serbia;Taiwan;Estonia;Slovakia;Ukraine;Romania;Australia;Bulgaria;South Africa;Latvia;New Zealand;Korea, Republic of
20EUCTR2015-000555-24-FR
(EUCTR)
28/12/201603/01/2017Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Academic Medical Center AmsterdamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4France;Spain;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-000852-12-NL
(EUCTR)
05/10/201630/05/2016Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
126Phase 4France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom
22EUCTR2016-000678-40-EE
(EUCTR)
22/08/201620/06/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
385Phase 4Serbia;Estonia;Taiwan;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
23EUCTR2016-000678-40-LV
(EUCTR)
19/08/201610/05/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
385Phase 4Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Malaysia;Poland;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
24EUCTR2015-000555-24-ES
(EUCTR)
11/08/201615/07/2016Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Academic Medical Center AmsterdamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4Spain;Netherlands
25NCT02630966
(ClinicalTrials.gov)
August 10, 201611/12/2015Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)Crohn's DiseaseDrug: Vedolizumab;Drug: PlaceboTakedaNULLCompleted18 Years80 YearsAll34Phase 4United States;Canada;France;Italy;Netherlands;Spain;United Kingdom;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02743806
(ClinicalTrials.gov)
August 1, 201615/4/2016Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's DiseaseEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's DiseaseColitis, Ulcerative;Crohn DiseaseDrug: VedolizumabTakedaNULLActive, not recruiting18 Years90 YearsAll331Phase 4Australia;Bulgaria;Czechia;Estonia;Hungary;India;Italy;Korea, Republic of;Latvia;Malaysia;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Turkey;Ukraine;Czech Republic;Slovakia;Taiwan
27EUCTR2015-000852-12-ES
(EUCTR)
20/07/201620/07/2016NCT02630966 TITLE A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn?s Disease SUMMARY The drug being tested in this study is called vedolizumab IV [intravenous(ly)]). Vedolizumab IV is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV. The study will enroll approximately 126 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups?which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): *Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient). *Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22. This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 43 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment. - ENTERPRISE Fistulizing Crohn?s Disease (CD)
MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
126Phase 4France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom
28EUCTR2015-000481-58-NL
(EUCTR)
14/07/201615/02/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
29EUCTR2015-000852-12-FR
(EUCTR)
13/07/201615/03/2019Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe, Ltd.NULLNot Recruiting Female: yes
Male: yes
126Phase 4United States;France;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom
30EUCTR2016-000678-40-HU
(EUCTR)
07/07/201619/05/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 19.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
385Phase 4Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Hungary;Czech Republic;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2015-000852-12-GB
(EUCTR)
07/07/201630/03/2016Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's DiseaseA Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE Fistulizing Crohn’s Disease (CD)
MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
INN or Proposed INN: vedolizumab
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom
32EUCTR2015-000481-58-BE
(EUCTR)
30/06/201614/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
33EUCTR2016-000678-40-CZ
(EUCTR)
27/06/201618/05/2016Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatmentEntyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Takeda Development Centre Europe LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
385Phase 4Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of
34EUCTR2015-000555-24-NL
(EUCTR)
16/06/201610/02/2016Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: vedolizumab
Other descriptive name: VEDOLIZUMAB
Academic Medical Center AmsterdamNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4Netherlands
35EUCTR2015-000481-58-DK
(EUCTR)
31/05/201617/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2015-000481-58-HU
(EUCTR)
09/05/201622/03/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
824Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden
37JPRN-JapicCTI-163220
15/4/201608/04/2016Vedolizumab Subcutaneous Long-Term Open-Label Extension StudyA Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease Ulcerative colitis or Crohn's diseaseIntervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to disease worsening or need for rescue medications will receive vedolizumab SC 108 mg QW.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Takeda Pharmaceutical Company LimitedNULLcomplete1880BOTH692Phase 3Japan, Refer to Othersection
38EUCTR2015-000481-58-BG
(EUCTR)
31/03/201616/02/2016Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
824Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
39JPRN-JapicCTI-163386
04/1/201628/09/2016Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's DiseaseA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy Crohn's DiseaseIntervention name : Vedolizumab SC 108 mg
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50
Takeda Pharmaceutical Company LimitedNULLcomplete1880BOTH644Phase 3Japan, Refer to Othersection
40NCT02611817
(ClinicalTrials.gov)
January 4, 201619/11/2015Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous TherapyCrohn's DiseaseDrug: Vedolizumab SC 108 mg;Drug: Placebo;Drug: Vedolizumab IV 300 mgTakedaNULLCompleted18 Years80 YearsAll644Phase 3United States;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2014-003509-13-BE
(EUCTR)
06/10/201510/07/2015Effect of Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Hungary;Canada;Poland;Belgium
42EUCTR2014-003509-13-PL
(EUCTR)
18/08/201512/06/2015Effect of Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Hungary;Canada;Belgium;Poland
43EUCTR2014-003509-13-CZ
(EUCTR)
25/06/201527/04/2015Effect of Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Hungary;Czech Republic;Canada;Belgium;Poland
44EUCTR2014-005376-29-BE
(EUCTR)
02/06/201503/02/2015An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Academic Medical Center, GastroenterologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 4Belgium;Netherlands
45EUCTR2014-003509-13-HU
(EUCTR)
15/05/201513/04/2015Vedolizumab IV in subjects with Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease Crohn's Disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: Vedolizumab IV (Entyvio™)
Product Name: Vedolizumab IV
Product Code: MLN0002
Takeda Development Centre Europe LtdNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Czech Republic;Hungary;Canada;Belgium;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
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PhaseCountries
46NCT02425111
(ClinicalTrials.gov)
March 30, 201526/3/2015Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's DiseaseAn Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IVCrohn's DiseaseDrug: VedolizumabTakedaNULLCompleted18 Years80 YearsAll101Phase 3United States;Belgium;Canada;Czechia;France;Hungary;Italy;Poland;Czech Republic
47EUCTR2017-002231-41-FR
(EUCTR)
15/12/2017A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s DiseaseA Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom