97. Ulcerative colitis Clinical trials / Disease details


Clinical trials : 2,630 Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202

  
16 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-005251-13-EE
(EUCTR)
31/03/201415/01/2014A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United 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
2EUCTR2011-005251-13-LV
(EUCTR)
03/03/201416/01/2014A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United 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
3EUCTR2011-005251-13-PL
(EUCTR)
23/04/201310/01/2013A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
4EUCTR2011-005251-13-NL
(EUCTR)
08/01/201323/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
315Phase 2United States;Estonia;Greece;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
5EUCTR2011-005251-13-DE
(EUCTR)
21/12/201209/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Latvia;Germany
6NCT01694485
(ClinicalTrials.gov)
November 16, 201224/9/2012Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative ColitisA 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 ColitisUlcerative ColitisBiological: Abrilumab;Drug: PlaceboAmgenNULLCompleted18 Years65 YearsAll359Phase 2United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Switzerland;United Kingdom;Czech Republic
7EUCTR2011-005251-13-IT
(EUCTR)
16/09/201227/08/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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.NULLNot RecruitingFemale: yes
Male: yes
315Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Poland;Belgium;Australia
8EUCTR2011-005251-13-BE
(EUCTR)
14/09/201218/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Latvia;Germany;Netherlands;Norway
9EUCTR2011-005251-13-HU
(EUCTR)
11/09/201218/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Germany;Norway
10EUCTR2011-005251-13-AT
(EUCTR)
10/09/201223/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
11EUCTR2011-005251-13-GB
(EUCTR)
06/09/201213/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot 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): noUnited States;Estonia;Greece;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany
12EUCTR2011-005251-13-DK
(EUCTR)
16/08/201211/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Latvia;Norway;Netherlands;Germany
13EUCTR2011-005251-13-CZ
(EUCTR)
26/07/201217/07/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
360Phase 2United States;Estonia;Greece;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Norway;Germany
14EUCTR2011-005251-13-GR
(EUCTR)
05/06/201214/05/2012A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitisA 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 IncNULLNot RecruitingFemale: yes
Male: yes
315Phase 2United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway
15NCT01290042
(ClinicalTrials.gov)
February 201127/1/2011Study 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 DiseaseDrug: AMG 181;Other: Placebo for AMG 181AmgenNULLCompleted18 Years65 YearsBoth43Phase 1United States;Australia
16NCT01164904
(ClinicalTrials.gov)
July 20101/7/2010Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative ColitisA 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 ColitisUlcerative ColitisDrug: Amg 181AmgenNULLTerminated18 Years55 YearsBoth72Phase 1United States;Australia;New Zealand