Vedolizumab IV ( DrugBank: Vedolizumab )

3 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
94	原発性硬化性胆管炎	12
96	クローン病	60
97	潰瘍性大腸炎	65

94. 原発性硬化性胆管炎

臨床試験数 : 142 / 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03035058 (ClinicalTrials.gov)	February 2017	25/1/2017	Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangit ...	A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficac ...	Primary Sclerosing Cholangitis;Inflammatory Bowel Disease	Drug: Vedolizumab;Drug: Placebo	Takeda	NULL	Withdrawn	18 Years	N/A	All	0	Phase 3	NULL
2	EUCTR2014-003942-28-FR (EUCTR)	04/07/2016	05/07/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 19.0;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;Franc ...
3	EUCTR2014-003942-28-IT (EUCTR)	20/06/2016	19/01/2021	Efficacy and Safety of Vedolizumab IVin the treatment of Primary Sclerosing Cholangitis in patients ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 20.1;Level: LLT ...	Trade Name: Entyvio	TAKEDA DEVELOPMENT CENTRE EUROPE LTD	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Czechia;Finland;Spain;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Ita ...
4	EUCTR2014-003942-28-PL (EUCTR)	15/06/2016	31/05/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 19.0;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;Franc ...
5	EUCTR2014-003942-28-ES (EUCTR)	29/05/2016	24/02/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 19.0;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;Franc ...
6	EUCTR2014-003942-28-GB (EUCTR)	26/05/2016	18/03/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 18.1;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;Franc ...
7	EUCTR2014-003942-28-BE (EUCTR)	13/05/2016	10/03/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 18.1;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;Franc ...
8	EUCTR2014-003942-28-DE (EUCTR)	09/05/2016	23/03/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 18.1;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;Franc ...
9	EUCTR2014-003942-28-HU (EUCTR)	09/05/2016	21/03/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 18.1;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;Franc ...
10	EUCTR2014-003942-28-AT (EUCTR)	13/04/2016	24/03/2016	Efficacy and Safety of Vedolizumab IVin the treatment of PrimarySclerosing Cholangitis in patients w ...	Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy ...	Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD) MedDRA version: 18.1;Level: LLT ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 3	United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;Franc ...

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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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04779320 (ClinicalTrials.gov)	February 28, 2022	1/3/2021	A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intrave ...	Crohn's Disease (CD)	Drug: Vedolizumab IV	Takeda	NULL	Not yet recruiting	2 Years	17 Years	All	120	Phase 3	NULL
2	NCT04804540 (ClinicalTrials.gov)	January 10, 2022	15/3/2021	A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease	A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizu ...	Ulcerative Colitis;Crohn Disease	Drug: Vedolizumab IV	Takeda	NULL	Not yet recruiting	18 Years	65 Years	All	150	Phase 4	NULL
3	JPRN-jRCT2031200371	04/06/2021	19/02/2021	A Study of Vedolizumab, given every 4 weeks, in Japanese Participants with Moderate to Severe Ulcera ...	An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous ( ...	Ulcerative Colitis, Crohn's Disease	Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of m ...	Shikamura Mitsuhiro	NULL	Recruiting	>= 18age old	<= 80age old	Both	158	Phase 3	Japan
4	NCT04738942 (ClinicalTrials.gov)	June 4, 2021	2/2/2021	A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate ...	An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous ( ...	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab	Takeda	NULL	Recruiting	18 Years	80 Years	All	158	Phase 3	Japan
5	NCT03196427 (ClinicalTrials.gov)	July 30, 2018	20/6/2017	Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis ...	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IVin Pediatric Subjects ...	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab	Takeda	Takeda Development Center Americas, Inc.	Active, not recruiting	2 Years	17 Years	All	80	Phase 2	United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom
6	EUCTR2017-002231-41-NL (EUCTR)	14/05/2018	26/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ul ...	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety an ...	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;T ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary ...
7	EUCTR2017-002182-21-NL (EUCTR)	20/03/2018	28/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis ...	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IVin Pediatric Subjects ...	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Te ...	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Oth ...	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom ...
8	EUCTR2017-002182-21-PL (EUCTR)	17/01/2018	13/10/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis ...	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IVin Pediatric Subjects ...	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Te ...	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Oth ...	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom ...
9	EUCTR2017-002231-41-PL (EUCTR)	17/01/2018	13/10/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ul ...	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety an ...	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;T ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom ...
10	EUCTR2017-002231-41-BE (EUCTR)	10/01/2018	14/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ul ...	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety an ...	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;T ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom ...

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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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04804540 (ClinicalTrials.gov)	January 10, 2022	15/3/2021	A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease	A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizu ...	Ulcerative Colitis;Crohn Disease	Drug: Vedolizumab IV	Takeda	NULL	Not yet recruiting	18 Years	65 Years	All	150	Phase 4	NULL
2	NCT04738942 (ClinicalTrials.gov)	June 4, 2021	2/2/2021	A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate ...	An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous ( ...	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab	Takeda	NULL	Recruiting	18 Years	80 Years	All	158	Phase 3	Japan
3	JPRN-jRCT2031200371	04/06/2021	19/02/2021	A Study of Vedolizumab, given every 4 weeks, in Japanese Participants with Moderate to Severe Ulcera ...	An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous ( ...	Ulcerative Colitis, Crohn's Disease	Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of m ...	Shikamura Mitsuhiro	NULL	Recruiting	>= 18age old	<= 80age old	Both	158	Phase 3	Japan
4	NCT04469062 (ClinicalTrials.gov)	April 20, 2021	10/7/2020	A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through St ...	Ulcerative Colitis	Drug: Mirikizumab IV;Drug: Mirikizumab SC;Drug: Vedolizumab IV;Drug: Placebo IV;Drug: Placebo SC	Eli Lilly and Company	NULL	Withdrawn	18 Years	80 Years	All	0	Phase 3	NULL
5	JPRN-jRCTs011200009	08/04/2021	06/11/2020	vedolizumab-4026	A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue ...	Subjects with UC	Vedolizumab 300 mg is administered at Week 0, 2, 6 and every 8 weeks thereafter. Treatment duration ...	Fujiya Mikihiro	Takeda Pharmaceutical Company Limited (Takeda)	Recruiting	>= 20age old	<= 80age old	Both	30	Phase 4	Japan
6	NCT03196427 (ClinicalTrials.gov)	July 30, 2018	20/6/2017	Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis ...	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IVin Pediatric Subjects ...	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab	Takeda	Takeda Development Center Americas, Inc.	Active, not recruiting	2 Years	17 Years	All	80	Phase 2	United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom
7	EUCTR2017-002231-41-NL (EUCTR)	14/05/2018	26/09/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ul ...	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety an ...	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;T ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary ...
8	EUCTR2017-002182-21-NL (EUCTR)	20/03/2018	28/09/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis ...	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IVin Pediatric Subjects ...	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Te ...	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Oth ...	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom ...
9	EUCTR2017-002231-41-PL (EUCTR)	17/01/2018	13/10/2017	A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ul ...	A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety an ...	Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;T ...	Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab ...	Takeda Development Centre Europe, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom ...
10	EUCTR2017-002182-21-PL (EUCTR)	17/01/2018	13/10/2017	An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis ...	A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IVin Pediatric Subjects ...	Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Te ...	Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Oth ...	Takeda Development Centre Europe, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 2	United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom ...

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