97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
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
| 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-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 |