VEDOLIZUMAB ( 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	170
97	潰瘍性大腸炎	226

94. 原発性硬化性胆管炎

臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141

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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 VedolizumabIntravenous (IV) in the Treatment of Primary Sclerosing Cholangiti ...	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	Primary Sclerosing Cholangitis;Inflammatory Bowel Disease	Drug: Vedolizumab;Drug: Placebo	Takeda	NULL	Withdrawn	18 Years	N/A	All	0	Phase 3	NULL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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 VedolizumabIV in 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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 VedolizumabIV in 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: VedolizumabIV Product Code: MLN0002 INN or Proposed INN: Vedolizumab O ...	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 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209

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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	NCT05442567 (ClinicalTrials.gov)	May 2, 2023	30/6/2022	A Study of Vedolizumabin Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) ...	A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ...	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab IV;Other: No Intervention	Takeda	NULL	Not yet recruiting	3 Years	17 Years	All	240	Phase 3	NULL
2	EUCTR2021-000630-34-GR (EUCTR)	13/01/2023	11/11/2022	A study to evaluate the long term safety of Vedolizumabin Pediatric Patients With Ulcerative Colitis ...	A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ...	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive Sy ...	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ...	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingd ...
3	EUCTR2021-000630-34-HR (EUCTR)	27/12/2022	05/01/2023	A study to evaluate the long term safety of Vedolizumabin Pediatric Patients With Ulcerative Colitis ...	A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ...	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive Sy ...	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ...	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingd ...
4	EUCTR2022-000837-17-NL (EUCTR)	07/12/2022	29/09/2022	Lengthening of vedolizumabinjections based on drug concentrations in patients with inflammatory bowe ...	Subcutaneous vedolizumabdrug de-escalation using therapeutic drug monitoring in inflammatory bowel d ...	Inflammatory bowel diseases (Crohn's disease, ulcerative colitis);Therapeutic area: Diseases [C] - D ...	Trade Name: Vedolizumab, Entyvio	Amsterdam UMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 4	Netherlands
5	JPRN-jRCT2071210031	30/04/2022	01/06/2021	A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ...	Crohn's Disease	Induction Period: Participants >=30 kg, Vedolizumab300 mg Vedolizumab300 mg, intravenous (IV) infusio ...	Shikamura Mitsuhiro	NULL	Recruiting	>= 2age old	<= 17age old	Both	120	Phase 3	United States;Australia;Belgium;Bosnia;Croatia;Czech Republic;Hungary;Germany;Italy;Israel;Lithuania ...
6	NCT04804540 (ClinicalTrials.gov)	December 29, 2021	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	Active, not recruiting	18 Years	65 Years	All	150	Phase 4	India
7	EUCTR2020-004301-31-IT (EUCTR)	13/10/2021	30/08/2021	A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ...	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ...	Moderately to severely active Crohn's disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ...	Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO ...	TAKEDA DEVELOPMENT CENTER AMERICAS INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;B ...
8	EUCTR2020-004301-31-SK (EUCTR)	18/09/2021	28/04/2021	A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ...	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ...	Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ...	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ...	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of;Canada;United States;Czechia;Slovaki ...
9	EUCTR2020-004301-31-HR (EUCTR)	17/08/2021	02/09/2021	A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ...	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ...	Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ...	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ...	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;B ...
10	EUCTR2020-004301-31-HU (EUCTR)	06/08/2021	28/04/2021	A study to evaluate efficacy and safety of Vedolizumabin pediatric subjects with moderately to sever ...	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ...	Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification co ...	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ...	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 3	United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;B ...

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97. 潰瘍性大腸炎

臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 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	NCT05442567 (ClinicalTrials.gov)	May 2, 2023	30/6/2022	A Study of Vedolizumabin Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) ...	A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ...	Ulcerative Colitis;Crohn's Disease	Drug: Vedolizumab IV;Other: No Intervention	Takeda	NULL	Not yet recruiting	3 Years	17 Years	All	240	Phase 3	NULL
2	NCT05771155 (ClinicalTrials.gov)	May 2023	1/3/2023	Efficacy, Safety and Immunogenicity of the Proposed Biosimilar VedolizumabPB016 in Comparison With E ...	A Randomized, Double-blind, Multicenter Phase 3 Study in Patients With Moderately to Severely Active ...	Ulcerative Colitis	Biological: Intravenous (IV) infusions	Polpharma Biologics S.A.	NULL	Not yet recruiting	18 Years	75 Years	All	750	Phase 3	NULL
3	NCT05702879 (ClinicalTrials.gov)	April 1, 2023	18/1/2023	Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy ...	An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clin ...	Ulcerative Colitis	Drug: Ozanimod;Drug: TNF Inhibitor;Drug: Steroids;Drug: Vedolizumab;Drug: Ustekinumab	University Hospital Inselspital, Berne	Bristol-Myers Squibb	Not yet recruiting	18 Years	80 Years	All	240		NULL
4	EUCTR2021-000630-34-GR (EUCTR)	13/01/2023	11/11/2022	A study to evaluate the long term safety of Vedolizumabin Pediatric Patients With Ulcerative Colitis ...	A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ...	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive Sy ...	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ...	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingd ...
5	EUCTR2021-000630-34-HR (EUCTR)	27/12/2022	05/01/2023	A study to evaluate the long term safety of Vedolizumabin Pediatric Patients With Ulcerative Colitis ...	A Phase 3b Extension Study to Evaluate the Long-term Safety of VedolizumabIntravenous in Pediatric P ...	Active Ulcerative Colitis (UC) or Crohn's disease (CD);Therapeutic area: Diseases [C] - Digestive Sy ...	Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: ...	Takeda Development Center Americas, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	93	Phase 3	United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingd ...
6	EUCTR2022-000837-17-NL (EUCTR)	07/12/2022	29/09/2022	Lengthening of vedolizumabinjections based on drug concentrations in patients with inflammatory bowe ...	Subcutaneous vedolizumabdrug de-escalation using therapeutic drug monitoring in inflammatory bowel d ...	Inflammatory bowel diseases (Crohn's disease, ulcerative colitis);Therapeutic area: Diseases [C] - D ...	Trade Name: Vedolizumab, Entyvio	Amsterdam UMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 4	Netherlands
7	NCT05186623 (ClinicalTrials.gov)	February 5, 2022	22/12/2021	Prediction Model for Response to Biologics and Small Molecular Agent for UC	Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerativ ...	Ulcerative Colitis	Drug: Vedolizumab, Ustekinumab, or Tofacitinib	Asan Medical Center	NULL	Recruiting	18 Years	79 Years	All	300		Korea, Republic of
8	NCT04804540 (ClinicalTrials.gov)	December 29, 2021	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	Active, not recruiting	18 Years	65 Years	All	150	Phase 4	India
9	JPRN-jRCT1051210145	28/12/2021	28/12/2021	Efficacy of therapeutic intervention with vedolizumabfor ulcerative colitis patients with no or mild ...	Efficacy of therapeutic intervention with vedolizumabfor ulcerative colitis patients with no or mild ...	ulcerative colitis ulcerative colitis;D003093	Administration of vedolizumab300mg/day at 0,2, and 6 weeks, then at 8-week intervals for up to 54 we ...	ooi makoto	NULL	Recruiting	>= 18age old	<= 80age old	Both	150	Phase 3	Japan
10	JPRN-jRCT2071210030	19/10/2021	31/05/2021	A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis	A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of VedolizumabIntraven ...	Colitis, Ulcerative	Induction Period: Participants >=30 kg, Vedolizumab300 mg Vedolizumab300 mg, intravenous (IV) infusio ...	Shikamura Mitsuhiro	NULL	Recruiting	>= 2age old	<= 17age old	Both	120	Phase 3	United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania ...

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