DIMS0150 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎15

97. 潰瘍性大腸炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003023-14-SE
(EUCTR)
02/09/202123/06/2021Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative ColitisPharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis Moderate to Severe 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 Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Sweden
2EUCTR2016-004217-26-IT
(EUCTR)
22/02/201822/02/2018A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT Moderate to Severe left-sided Active Ulcerative Colitis
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Cobitolimod
Product Code: DIMs0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
INDEX PHARMACEUTICALS ABNULLNot RecruitingFemale: yes
Male: yes
215Phase 2Serbia;Spain;Ukraine;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Germany;Sweden
3EUCTR2016-004217-26-SE
(EUCTR)
20/09/201703/03/2017A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot Recruiting Female: yes
Male: yes
215 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
4EUCTR2016-004217-26-FR
(EUCTR)
22/06/201731/08/2017A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot Recruiting Female: yes
Male: yes
215 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
5EUCTR2016-004217-26-CZ
(EUCTR)
09/06/201731/03/2017A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot Recruiting Female: yes
Male: yes
215 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
6EUCTR2016-004217-26-ES
(EUCTR)
08/06/201710/03/2017A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot Recruiting Female: yes
Male: yes
215 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
7EUCTR2016-004217-26-DE
(EUCTR)
21/04/201716/02/2017A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot RecruitingFemale: yes
Male: yes
215Phase 2Serbia;France;Hungary;Czech Republic;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
8EUCTR2016-004217-26-HU
(EUCTR)
20/04/201723/02/2017A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
Product Name: Cobitolimod
Product Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot Recruiting Female: yes
Male: yes
215 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;Czech Republic;Hungary;Poland;Spain;Ukraine;Romania;Russian Federation;Germany;Italy;Sweden
9EUCTR2011-003130-14-IT
(EUCTR)
12/03/201205/03/2012Clinical Trial to assess the efficacy and safety of KappaproctA placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients” - CSUC-01/10 Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Kappaproct
Product Code: DIMS0150
INN or Proposed INN: NA
Other descriptive name: NA
INDEX PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
132Czech Republic;Hungary;Poland;Germany;United Kingdom;Italy
10EUCTR2011-003130-14-CZ
(EUCTR)
13/01/201214/10/2011A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatmentA placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients Chronic active treatment refractory ulcerative colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Kappaproct
INN or Proposed INN: DIMS0150
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot RecruitingFemale: yes
Male: yes
120Hungary;Czech Republic;Poland;Germany;Italy;United Kingdom
11EUCTR2011-003130-14-DE
(EUCTR)
30/12/201119/09/2011A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatmentA placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients Chronic active treatment refractory ulcerative colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Kappaproct
INN or Proposed INN: DIMS0150
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot RecruitingFemale: yes
Male: yes
120Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom
12EUCTR2011-003130-14-PL
(EUCTR)
22/12/201110/10/2011A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatmentA placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Kappaproct
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot RecruitingFemale: yes
Male: yes
120Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom
13EUCTR2011-003130-14-HU
(EUCTR)
14/10/201101/09/2011A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatmentA placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients Chronic active treatment refractory ulcerative colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Kappaproct
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom
14EUCTR2011-003130-14-GB
(EUCTR)
06/10/201111/08/2011A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatmentA placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Kappaproct
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Hungary;Poland;Germany;Italy;United Kingdom
15EUCTR2006-001846-15-SE
(EUCTR)
06/12/200620/10/2006A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degreeA placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree Active ulcerative colitis in steroid refractory or steroid dependent patientsProduct Name: Kappaproct
Product Code: DIMS0150
InDex Pharmaceuticals ABNULLNot RecruitingFemale: yes
Male: yes
48Sweden