DDrare: Database of Drug Development for Rare 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	0
96	クローン病	2
97	潰瘍性大腸炎	5

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	NCT03142321 (ClinicalTrials.gov)	June 8, 2018	3/5/2017	Defining Predictors of RT Response to Vedolizumab in IBD	Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers	Crohn Disease of Small Intestine	Drug: Vedolizumab 300 MG Injection [Entyvio]	Washington University School of Medicine	NULL	Recruiting	18 Years	N/A	All	80	Phase 4	United States
2	NCT03329209 (ClinicalTrials.gov)	March 5, 2018	30/10/2017	A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants	An Open-Label, Single-Center, Phase 1 Study to Determine the Pharmacokinetics of Single Intravenous Dose of Vedolizumab 300 mg in Healthy Adult Chinese Subjects	Colitis, Ulcerative;Crohn Disease	Drug: Vedolizumab	Takeda	NULL	Completed	18 Years	45 Years	All	16	Phase 1	China

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	JPRN-jRCTs011200009	06/11/2020	06/11/2020	vedolizumab-4026	A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue and in the serum concentrations, alpha4beta7 integrin receptor occupancy and the efficacy in subjects with moderately to severely active ulcerative colitis and treated by vedolizumab IV - vedolizumab-4026	Subjects with UC	Vedolizumab 300 mg is administered at Week 0, 2, 6 and every 8 weeks thereafter. Treatment duration is 46 weeks.	Fujiya Mikihiro	Fernandez Jovelle;Takeda Pharmaceutical Company Limited (Takeda)	Pending	>= 20age old	<= 80age old	Both	30	Phase 4	Japan
2	NCT02611830 (ClinicalTrials.gov)	December 18, 2015	19/11/2015	Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy	Colitis, Ulcerative	Drug: Vedolizumab 300 mg IV;Drug: Placebo IV;Drug: Vedolizumab 108 mg SC;Drug: Placebo SC	Takeda	NULL	Completed	18 Years	80 Years	All	383	Phase 3	United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic
3	JPRN-JapicCTI-163222	18/12/2015	08/04/2016	Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis	A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy	Colitis, Ulcerative	Intervention name : Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 108 mg SC : Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab subcutaneous (SC), 108 mg, injection, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W), starting at Week 6 up to approximately Week 50. Intervention name : Vedolizumab IV, Placebo SC INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 300 mg IV: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50. Intervention name : Vedolizumab IV, Placebo IV, Placebo SC INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Induction IV + Placebo: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching SC injections, Q2W and placebo-matching IV infusions, Q8W starting at Week 6 up to approximately Week 50. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Takeda Pharmaceutical Company Limited	NULL	complete	18	80	BOTH	383	Phase 3	Japan, Japan, Refer to Other section
4	NCT02646657 (ClinicalTrials.gov)	July 2015	27/8/2015	An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis	An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Ulcerative Colitis: the LOVE-UC Study (LOw Countries VEdolizumab in UC Study)	Colitis, Ulcerative	Drug: Vedolizumab 300 mg	Geert D'Haens	Takeda	Completed	18 Years	80 Years	All	120	Phase 4	Belgium;Hungary;Netherlands
5	JPRN-JapicCTI-142403	04/2/2014	27/12/2013	Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis	Phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe ulcerative colitis	Ulcerative colitis	Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Induction Phase: Cohort 1/Cohort 2: Vedolizumab 300 mg; Vedolizumab 300 mg, IV intravenous (IV) infusion, once at Weeks 0, 2, and 6 in the induction phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Phase: Cohort 1, Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 0, 2 and 6 in the induction phase. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Maintenance Phase: Placebo continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in	TAKEDA PHARMACEUTICAL COMPANY LTD.	NULL	complete	15	80	BOTH	292	Phase 3	Japan

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

JPRN-jRCTs011200009

06/11/2020

vedolizumab-4026

A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue and in the serum concentrations, alpha4beta7 integrin receptor occupancy and the efficacy in subjects with moderately to severely active ulcerative colitis and treated by vedolizumab IV - vedolizumab-4026

Subjects with UC

Vedolizumab 300 mg is administered at Week 0, 2, 6 and every 8 weeks thereafter. Treatment duration is 46 weeks.

Fujiya Mikihiro

Fernandez Jovelle;Takeda Pharmaceutical Company Limited (Takeda)

Pending

>= 20age old

<= 80age old

Both

Phase 4

Japan

NCT02611830
(ClinicalTrials.gov)

December 18, 2015

19/11/2015

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Colitis, Ulcerative

Drug: Vedolizumab 300 mg IV;Drug: Placebo IV;Drug: Vedolizumab 108 mg SC;Drug: Placebo SC

Takeda

NULL

Completed

18 Years

80 Years

All

383

Phase 3

United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic

JPRN-JapicCTI-163222

18/12/2015

08/04/2016

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Colitis, Ulcerative

Intervention name : Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 108 mg SC : Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab subcutaneous (SC), 108 mg, injection, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W), starting at Week 6 up to approximately Week 50.
Intervention name : Vedolizumab IV, Placebo SC
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 300 mg IV: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Intervention name : Vedolizumab IV, Placebo IV, Placebo SC
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Induction IV + Placebo: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching SC injections, Q2W and placebo-matching IV infusions, Q8W starting at Week 6 up to approximately Week 50.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Takeda Pharmaceutical Company Limited

NULL

complete

BOTH

383

Phase 3

Japan, Japan, Refer to Other section

NCT02646657
(ClinicalTrials.gov)

July 2015

27/8/2015

An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis

An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Ulcerative Colitis: the LOVE-UC Study (LOw Countries VEdolizumab in UC Study)

Colitis, Ulcerative

Drug: Vedolizumab 300 mg

Geert D'Haens

Takeda

Completed

18 Years

80 Years

All

120

Phase 4

Belgium;Hungary;Netherlands

JPRN-JapicCTI-142403

04/2/2014

27/12/2013

Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis

Phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe ulcerative colitis

Ulcerative colitis

Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Induction Phase: Cohort 1/Cohort 2: Vedolizumab 300 mg; Vedolizumab 300 mg, IV intravenous (IV) infusion, once at Weeks 0, 2, and 6 in the induction phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Induction Phase: Cohort 1, Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Maintenance Phase: Placebo continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in

TAKEDA PHARMACEUTICAL COMPANY LTD.

NULL

complete

BOTH

292

Phase 3

Japan