VIDOFLUDIMUS CALCIUM ( DrugBank: Calcium, Vidofludimus )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎5
94原発性硬化性胆管炎1
96クローン病4
97潰瘍性大腸炎7

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000048-23-DE
(EUCTR)
03/03/202207/10/2021Study to test IMU-838 in patients with progressive multiple sclerosisMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study Progressive forms of Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2United States;Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of
2EUCTR2021-000048-23-NL
(EUCTR)
10/02/202212/10/2021Study to test IMU-838 in patients with progressive multiple sclerosisMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study Progressive forms of Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;United States;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Canada;Poland;Romania;Bulgaria;Netherlands;Germany;Moldova, Republic of
3EUCTR2021-000028-36-BG
(EUCTR)
18/01/202208/11/2021Not applicableA Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1) - ENSURE-1 Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Product Name: Vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IMU-838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1050Phase 3United States;Belarus;Greece;Ukraine;Lithuania;North Macedonia;Russian Federation;Colombia;India;Mexico;Poland;Bulgaria;Albania;Georgia;Moldova, Republic of
4EUCTR2021-000048-23-BG
(EUCTR)
28/10/202128/09/2021Study to test IMU-838 in patients with progressive multiple sclerosisMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis - CALLIPER Study Progressive forms of Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 2Serbia;Czechia;Finland;Ukraine;North Macedonia;Russian Federation;Hungary;Poland;Romania;Bulgaria;Germany;Netherlands;Moldova, Republic of
5EUCTR2018-001896-19-BG
(EUCTR)
17/12/201811/10/2018Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) - EMPhASIS relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Product Name: VIDOFLUDIMUS CALCIUM
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Phase 2Poland;Ukraine;Romania;Bulgaria

94. 原発性硬化性胆管炎


臨床試験数 : 142 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03722576
(ClinicalTrials.gov)
June 17, 201925/10/2018Vidofludimus Calcium for Primary Sclerosing CholangitisInvestigation of the Activity of Vidofludimus Calcium, a Novel, Orally Available, Small Molecule Inhibitor of Dihydroorotate Dehydrogenase, as a Treatment for Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: Vidofludimus calciumElizabeth CareyArizona State UniversityCompleted18 Years75 YearsAll14Phase 2United States

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001895-39-HR
(EUCTR)
21/11/201920/01/2020A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
2EUCTR2018-001895-39-NL
(EUCTR)
27/09/201903/06/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany
3EUCTR2018-001895-39-BG
(EUCTR)
05/09/201916/07/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands
4EUCTR2018-001895-39-CZ
(EUCTR)
06/06/201905/03/2019A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s diseaseA phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 Crohn’s disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 2United States;Serbia;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands

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
1EUCTR2017-003703-22-BG
(EUCTR)
07/04/202006/02/2020Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;Russian Federation;North Macedonia;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
2EUCTR2017-003703-22-PT
(EUCTR)
02/03/202018/12/2019Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
3EUCTR2017-003703-22-HR
(EUCTR)
20/11/201913/01/2020Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Bosnia and Herzegovina;Netherlands;Germany;Bulgaria;Romania;Croatia;Poland;Belgium;United Kingdom;Russian Federation;North Macedonia;Ukraine;Spain;Czechia;Portugal;Belarus;Serbia;United States
4EUCTR2017-003703-22-PL
(EUCTR)
25/04/201926/04/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
5EUCTR2017-003703-22-NL
(EUCTR)
24/07/201805/03/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Portugal;Belarus;Serbia;United States;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Bosnia and Herzegovina
6EUCTR2017-003703-22-GB
(EUCTR)
03/05/201831/01/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838
Immunic AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 2Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
7EUCTR2017-003703-22-ES
(EUCTR)
29/04/201820/02/2018Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 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: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Immunic AGNULLNot Recruiting Female: yes
Male: yes
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom