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 | EUCTR2011-005251-13-EE (EUCTR) | 31/03/2014 | 15/01/2014 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Germany;Netherlands;Norway;New Zealand | ||
| 2 | EUCTR2011-005251-13-LV (EUCTR) | 03/03/2014 | 16/01/2014 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Netherlands;Norway;Germany;New Zealand | ||
| 3 | EUCTR2011-005251-13-PL (EUCTR) | 23/04/2013 | 10/01/2013 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 4 | EUCTR2011-005251-13-NL (EUCTR) | 08/01/2013 | 23/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Estonia;Greece;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 5 | EUCTR2011-005251-13-DE (EUCTR) | 21/12/2012 | 09/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Latvia;Germany | ||
| 6 | NCT01694485 (ClinicalTrials.gov) | November 16, 2012 | 24/9/2012 | Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis | A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Biological: Abrilumab;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 359 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Switzerland;United Kingdom;Czech Republic |
| 7 | EUCTR2011-005251-13-IT (EUCTR) | 16/09/2012 | 27/08/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG181 Product Code: AMG181 | AMGEN INC. | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Poland;Belgium;Australia | ||
| 8 | EUCTR2011-005251-13-BE (EUCTR) | 14/09/2012 | 18/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Latvia;Germany;Netherlands;Norway | ||
| 9 | EUCTR2011-005251-13-HU (EUCTR) | 11/09/2012 | 18/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Germany;Norway | ||
| 10 | EUCTR2011-005251-13-AT (EUCTR) | 10/09/2012 | 23/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 11 | EUCTR2011-005251-13-GB (EUCTR) | 06/09/2012 | 13/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Estonia;Greece;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany | ||
| 12 | EUCTR2011-005251-13-DK (EUCTR) | 16/08/2012 | 11/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Latvia;Norway;Netherlands;Germany | ||
| 13 | EUCTR2011-005251-13-CZ (EUCTR) | 26/07/2012 | 17/07/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2 | United States;Estonia;Greece;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Norway;Germany | ||
| 14 | EUCTR2011-005251-13-GR (EUCTR) | 05/06/2012 | 14/05/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway | ||
| 15 | NCT01290042 (ClinicalTrials.gov) | February 2011 | 27/1/2011 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. | A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease. | Ulcerative Colitis;Crohn's Disease | Drug: AMG 181;Other: Placebo for AMG 181 | Amgen | NULL | Completed | 18 Years | 65 Years | Both | 43 | Phase 1 | United States;Australia |
| 16 | NCT01164904 (ClinicalTrials.gov) | July 2010 | 1/7/2010 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Amg 181 | Amgen | NULL | Terminated | 18 Years | 55 Years | Both | 72 | Phase 1 | United States;Australia;New Zealand |