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	0
97	潰瘍性大腸炎	1

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-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

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-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