97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
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. | 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 | NCT04314375 (ClinicalTrials.gov) | April 2022 | 17/3/2020 | Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Not yet recruiting | 5 Years | 17 Years | All | 70 | Phase 4 | NULL |
| 2 | 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 Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >=30 kg were included in this arm. Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Wee | 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;Poland;New Zealand;Romania;Russia;Slovakia;Spain;United Kingdom;Israel;China;Ukraine;Japan |
| 3 | NCT04857112 (ClinicalTrials.gov) | September 29, 2021 | 19/4/2021 | Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis | A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: Placebo | Bausch Health Americas, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 336 | Phase 2 | United States |
| 4 | NCT04331639 (ClinicalTrials.gov) | November 1, 2020 | 23/3/2020 | High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy | Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab | Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis;Vitamin D Deficiency | Dietary Supplement: vitamin D3 | Boston Children's Hospital | NULL | Recruiting | 5 Years | 25 Years | All | 50 | Phase 2 | United States |
| 5 | NCT03162432 (ClinicalTrials.gov) | August 1, 2017 | 15/5/2017 | High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade | High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade | IBD;Ulcerative Colitis;Crohn Disease | Drug: Vitamin D3 | Boston Children's Hospital | NULL | Completed | 7 Years | 25 Years | All | 50 | Phase 3 | United States |
| 6 | NCT02493712 (ClinicalTrials.gov) | January 2016 | 7/7/2015 | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: High dose;Drug: Low dose;Drug: Placebo | Holy Stone Healthcare Co., Ltd | inVentiv Health Clinical | Completed | 18 Years | 75 Years | All | 51 | Phase 2 | Italy;Taiwan |
| 7 | NCT02093663 (ClinicalTrials.gov) | December 12, 2014 | 17/3/2014 | Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases | Ulcerative Colitis | Drug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose) | Shire | NULL | Completed | 5 Years | 17 Years | All | 107 | Phase 3 | United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands |
| 8 | NCT01959165 (ClinicalTrials.gov) | November 21, 2013 | 8/10/2013 | MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients | Ulcerative Colitis | Drug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching Placebo | AstraZeneca | NULL | Completed | 18 Years | 65 Years | All | 44 | Phase 2 | Japan | |
| 9 | NCT01240915 (ClinicalTrials.gov) | February 2011 | 10/11/2010 | A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis | Colitis, Ulcerative | Drug: placebo;Drug: MultiStem low dose;Drug: MultiStem high dose | Pfizer | Athersys, Inc | Completed | 18 Years | N/A | All | 105 | Phase 2 | United States;Belgium;Canada;Germany;Hungary;Italy;Slovakia;Sweden |
| 10 | EUCTR2006-005299-42-BE (EUCTR) | 20/05/2008 | 07/03/2008 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain | |||
| 11 | NCT00659802 (ClinicalTrials.gov) | February 7, 2008 | 8/4/2008 | Phase II Study of HMPL-004 in Patients With Ulcerative Colitis | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine | Ulcerative Colitis | Drug: HMPL-004 low dose;Drug: Placebo;Drug: HMPL-004 high dose | Hutchison Medipharma Limited | NULL | Completed | 18 Years | N/A | All | 224 | Phase 2 | United States |
| 12 | EUCTR2006-005299-42-FR (EUCTR) | 16/05/2007 | 06/03/2007 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain |