MLN0002 (Vedolizumab) ( DrugBank: Vedolizumab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病1
97潰瘍性大腸炎1

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-142402
28/1/201427/12/2013Phase III study of MLN0002 (300 mg) in treatment of Crohn's diseasePhase III, 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 Crohn's disease Crohn's diseaseIntervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Vedolizumab (300 mg) administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Vedolizumab Placebo administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter.
Takeda Pharmaceutical Company LimitedNULLcomplete1580BOTH157Phase 3Japan

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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-142403
04/2/201427/12/2013Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitisPhase 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 colitisIntervention 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.NULLcomplete1580BOTH292Phase 3Japan