COBITOLIMOD ( DrugBank: Cobitolimod )


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22

97. 潰瘍性大腸炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-002549-13-PT
(EUCTR)
02/08/202227/10/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex Pharmaceuticals ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Serbia;United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
2EUCTR2021-002549-13-DK
(EUCTR)
21/04/202224/01/2022A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;New Zealand;Sweden
3EUCTR2021-002549-13-AT
(EUCTR)
31/03/202225/10/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden;United States;Taiwan;Portugal;Serbia
4EUCTR2021-002549-13-NO
(EUCTR)
07/03/202224/11/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3United States;Portugal;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
5EUCTR2021-002549-13-HR
(EUCTR)
24/02/202228/02/2022A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
6EUCTR2021-002549-13-SK
(EUCTR)
02/12/202124/08/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex Pharmaceuticals ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
7EUCTR2021-002549-13-LT
(EUCTR)
02/12/202106/09/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
8NCT04985968
(ClinicalTrials.gov)
November 24, 202122/7/2021The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative ColitisUlcerative ColitisDrug: Cobitolimod 250 mg;Drug: Cobitolimod 500 mg;Drug: PlaceboInDex PharmaceuticalsNULLRecruiting18 YearsN/AAll440Phase 3United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Croatia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Serbia;Slovakia;Sweden;Turkey;United Kingdom;Korea, Democratic People's Republic of
9EUCTR2021-002549-13-IT
(EUCTR)
22/11/202119/10/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
Product Code: [-]
INN or Proposed INN: Cobitolimod
Product Name: Cobitolimod
Product Code: [-]
INN or Proposed INN: Cobitolimod
INDEX PHARMACEUTICALS ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
10NCT05404074
(ClinicalTrials.gov)
November 22, 202117/5/2022Pharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative ColitisPharmacokinetics of Cobitolimod Enemas in Participants With Active Ulcerative ColitisUlcerative ColitisDrug: Cobitolimod 500mgInDex PharmaceuticalsNULLRecruiting18 YearsN/AAll6Phase 1Sweden
11EUCTR2021-002549-13-DE
(EUCTR)
20/10/202128/06/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;New Zealand;Sweden
12EUCTR2021-002549-13-HU
(EUCTR)
24/09/202123/07/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
13EUCTR2021-002549-13-SE
(EUCTR)
07/09/202116/06/2021A Phase III Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative ColitisA Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis - CONCLUDE Moderate to Severe left-sided 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: Cobitolimod
INN or Proposed INN: COBITOLIMOD
Product Name: Cobitolimod
INN or Proposed INN: COBITOLIMOD
InDex PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;New Zealand;Sweden
14EUCTR2021-003023-14-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
15EUCTR2016-004217-26-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
16EUCTR2016-004217-26-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
17EUCTR2016-004217-26-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
18NCT03178669
(ClinicalTrials.gov)
June 21, 20175/6/2017The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative ColitisA Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis PatientsUlcerative ColitisDrug: cobitolimod;Drug: PlaceboInDex PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll213Phase 2Czechia;France;Germany;Hungary;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine
19EUCTR2016-004217-26-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
20EUCTR2016-004217-26-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
21EUCTR2016-004217-26-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
22EUCTR2016-004217-26-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