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 | NCT04314375 (ClinicalTrials.gov) | March 2023 | 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-jRCT2021220013 | 01/07/2022 | 18/06/2022 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response to Conventional Therapy | Ulcerative Colitis (UC) | Ozanimod High Dose Ozanimod Low Dose | Liu W. Jerry | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 2-3 | France;United States;Japan |
| 3 | JPRN-jRCT2011210030 | 11/01/2022 | 30/08/2021 | Phase 2 Dose-finding UC Study | A 54-Week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Expedition Lead-in | Ulcerative Colitis, Colitis, Ulcerative, IBD | - Brazikumab low dose: IV brazikumab 720 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Brazikumab high-dose: IV brazikumab 1440 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10 - Placebo: IV placebo at Week 0 (Day 1), Week 2, and Week 6 followed by SC placebo every 4 weeks beginning at Week 10 | Ageishi Yuji | NULL | Recruiting | >= 18age old | <= 80age old | Both | 21 | Phase 2 | Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;United States;Japan |
| 4 | 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 Week 14 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 Week 14 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 Week 14 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 |
| 5 | 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 |
| 6 | JPRN-JapicCTI-163356 | 29/9/2016 | 23/08/2016 | I6T-MC-AMAC | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : Induction:High, Mid or Low dose LY3074828. Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:LY3074828 dose schedule1 or 2. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction:Placebo Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:Placebo | Eli Lilly Japan K.K. | NULL | complete | 18 | 75 | BOTH | 30 | Phase 2 | Japan, North America, Europe, Oceania |
| 7 | 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 |
| 8 | NCT02200445 (ClinicalTrials.gov) | February 2015 | 22/7/2014 | Low Dose IL-2 for Ulcerative Colitis | A Phase I Study of Low Dose Subcutaneous Interleukin-2 (IL-2) For The Treatment of Ulcerative Colitis. | Ulcerative Colitis | Drug: Interleukin-2 (aldesleukin). | Scott Snapper | NULL | Completed | 18 Years | 70 Years | All | 26 | Phase 1 | United States |
| 9 | 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 |
| 10 | NCT01988506 (ClinicalTrials.gov) | January 6, 2014 | 7/11/2013 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Completed | 18 Years | N/A | All | 81 | Phase 2 | France |
| 11 | 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 | |
| 12 | NCT01810185 (ClinicalTrials.gov) | March 2013 | 11/3/2013 | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Low dose naltrexone;Drug: Placebo | Santa Barbara Cottage Hospital | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States |
| 13 | NCT01697670 (ClinicalTrials.gov) | September 2012 | 28/9/2012 | Photodynamic Therapy for Ulcerative Colitis | A Multicenter, Open Phase II Study to Assess the Effect and Safety of Low Dose Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis | Ulcerative Colitis | Drug: Photodynamic therapy with Gliolan | University of Zurich | Swiss National Science Foundation | Recruiting | 18 Years | N/A | Both | 7 | Phase 1 | Switzerland |
| 14 | 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 |
| 15 | 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 |