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

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002981-64-BG
(EUCTR)
20/01/201625/09/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLNot RecruitingFemale: yes
Male: yes
165Phase 2United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
2EUCTR2014-002981-64-NL
(EUCTR)
12/10/201519/05/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2United States;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand
3EUCTR2014-002981-64-DE
(EUCTR)
29/09/201508/06/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
4EUCTR2014-002981-64-HU
(EUCTR)
14/09/201527/05/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2United States;Slovakia;Ukraine;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand
5EUCTR2014-002981-64-IT
(EUCTR)
20/08/201505/11/2020Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA Phase 2, randomized, placebo-controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis - na Subjects with active 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: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: [CC-10004]
INN or Proposed INN: Apremilast
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
CELGENE CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
165Phase 2United States;Czechia;Slovakia;Spain;Ukraine;Turkey;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
6EUCTR2014-002981-64-CZ
(EUCTR)
13/08/201505/05/2015Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown originA PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC-10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Celgene CorporationNULLNot Recruiting Female: yes
Male: yes
165 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand
7NCT02289417
(ClinicalTrials.gov)
January 8, 201510/11/2014Efficacy and Safety Study of Apremilast to Treat Active Ulcerative ColitisA Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: Apremilast;Drug: PlaceboAmgenNULLCompleted18 YearsN/AAll170Phase 2United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic