MT-1303 ( DrugBank: - )


3 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25
96クローン病15
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 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02310048
(ClinicalTrials.gov)
November 201414/11/2014Comparative Oral Bioavailability Study of MT-1303A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male SubjectsRelapsing-remitting Multiple SclerosisDrug: MT-1303-FormA;Drug: MT-1303-FormBMitsubishi Tanabe Pharma CorporationNULLCompleted18 Years55 YearsMale34Phase 1United Kingdom
2NCT02193217
(ClinicalTrials.gov)
September 201415/7/2014A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303Relapsing-remitting Multiple SclerosisDrug: MT-1303-Low;Drug: MT-1303-High;Drug: Fingolimod;Drug: PlaceboMitsubishi Tanabe Pharma CorporationNULLCompleted18 Years55 YearsBoth81Phase 1United Kingdom
3NCT02293967
(ClinicalTrials.gov)
September 201414/11/2014Mass Balance Study of MT-1303An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.Relapsing-remitting Multiple SclerosisDrug: MT-1303Mitsubishi Tanabe Pharma CorporationNULLCompleted30 Years65 YearsMale8Phase 1United Kingdom
4EUCTR2012-002639-27-BE
(EUCTR)
02/09/201306/02/2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
5NCT01890655
(ClinicalTrials.gov)
August 201326/6/2013Extension Study of MT-1303A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 StudyRelapsing-remitting Multiple SclerosisDrug: MT-1303-Low;Drug: MT-1303-Middle;Drug: MT-1303-HighMitsubishi Tanabe Pharma CorporationNULLCompleted18 Years60 YearsBoth367Phase 2Belgium;Bulgaria;Canada;Croatia;Czech Republic;Finland;Germany;Hungary;Italy;Lithuania;Poland;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom
6EUCTR2012-002639-27-IT
(EUCTR)
21/05/201311/04/2013A phase II, multicentre study to evaluate the long-term safety and efficacyof MT-1303 in subjects with relapsing-remitting multiple sclerosis whohave completed the MT-1303-E04 study A phase II, multicentre study to evaluate the long-term safety and efficacyof MT-1303 in subjects with relapsing-remitting multiple sclerosis whohave completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: MT-1303 [0.1]
Product Code: MT-1303
Product Name: MT-1303 [0.2]
Product Code: MT-1303
Product Name: MT-1303 [0.4]
Product Code: MT-1303
MITSUBISHI TANABE PHARMA CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Bulgaria;Germany;Latvia;Sweden;Bosnia and Herzegovina
7EUCTR2012-002639-27-CZ
(EUCTR)
15/05/201328/02/2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2United Kingdom;Hungary;Czech Republic;Canada;Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden
8EUCTR2012-002639-27-LT
(EUCTR)
10/05/201322/02/2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
9EUCTR2012-002639-27-BG
(EUCTR)
30/04/201313/03/2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 18.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
10EUCTR2012-002639-27-PL
(EUCTR)
03/04/201304/03/2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 19.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
11EUCTR2012-002639-27-GB
(EUCTR)
11/03/201320/11/2012A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 16.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
12EUCTR2012-002470-31-LT
(EUCTR)
06/03/201305/09/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
13EUCTR2012-002639-27-ES
(EUCTR)
27/02/201309/01/2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 14.1;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
14EUCTR2012-002470-31-BE
(EUCTR)
25/02/201322/10/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
15EUCTR2012-002639-27-FI
(EUCTR)
19/02/201329/01/2013A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
16EUCTR2012-002470-31-BG
(EUCTR)
30/01/201303/01/2013A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden
17EUCTR2012-002470-31-IT
(EUCTR)
21/01/201313/12/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebocontrolled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;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: MT-1303
Product Code: MT-1303
Product Name: MT-1303
Product Code: MT-1303
Product Name: MT-1303
Product Code: MT-1303
MITSUBISHI PHARMA CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
400Phase 2Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Bosnia and Herzegovina
18EUCTR2012-002470-31-ES
(EUCTR)
16/01/201305/02/2013A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
19EUCTR2012-002470-31-FI
(EUCTR)
14/01/201302/10/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
20EUCTR2012-002639-27-HU
(EUCTR)
10/01/201322/11/2012A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 14.1;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
21NCT01742052
(ClinicalTrials.gov)
January 20132/12/2012Dose-finding Study of MT-1303A Phase II, Multicentre, Randomised, Double-blind,Parallel Group, Placebo-controlled, Dose-finding Study to Evaluate the Safety and Efficacy of Three Different Oral Doses of MT-1303 Administered for a Period of 24 Weeks in Subjects With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: MT-1303-Low;Drug: MT-1303-Middle;Drug: MT-1303-High;Drug: PlaceboMitsubishi Tanabe Pharma CorporationNULLCompleted18 Years60 YearsBoth415Phase 2Belgium;Bulgaria;Canada;Croatia;Czech Republic;Finland;Germany;Hungary;Italy;Lithuania;Poland;Russian Federation;Serbia;Spain;Switzerland;Turkey;Ukraine;United Kingdom
22EUCTR2012-002470-31-PL
(EUCTR)
17/12/201221/12/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Turkey;Lithuania;Russian Federation;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
23EUCTR2012-002470-31-CZ
(EUCTR)
04/12/201211/09/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 17.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden
24EUCTR2012-002470-31-HU
(EUCTR)
08/11/201225/09/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina
25EUCTR2012-002470-31-GB
(EUCTR)
29/10/201203/09/2012A study to assess safety and effectiveness of the study drug MT-1303 at different dosage strengthsA phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 15.0;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: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Serbia;Finland;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Italy;United Kingdom;Switzerland;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Bulgaria;Latvia;Germany;Sweden;Bosnia and Herzegovina

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02389790
(ClinicalTrials.gov)
August 201510/3/2015Extension Study of MT-1303 in Subjects With Crohn's DiseaseA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 StudyCrohn's DiseaseDrug: MT-1303Mitsubishi Tanabe Pharma CorporationNULLCompleted18 Years65 YearsAll46Phase 2Czechia;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine;Czech Republic
2EUCTR2014-002557-19-NL
(EUCTR)
10/04/201503/11/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy
3EUCTR2014-002556-77-PL
(EUCTR)
30/03/201520/01/2015A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
4EUCTR2014-002557-19-PL
(EUCTR)
30/03/201521/01/2015A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
5EUCTR2014-002556-77-NL
(EUCTR)
26/03/201503/11/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy
6NCT02378688
(ClinicalTrials.gov)
March 201527/2/2015Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's DiseaseCrohn's DiseaseDrug: MT-1303;Drug: PlaceboMitsubishi Tanabe Pharma CorporationNULLCompleted18 Years65 YearsBoth78Phase 2Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine
7EUCTR2014-002556-77-SK
(EUCTR)
20/01/201503/11/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
8EUCTR2014-002557-19-SK
(EUCTR)
20/01/201503/11/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
9EUCTR2014-002557-19-IT
(EUCTR)
03/01/201510/11/2014A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
10EUCTR2014-002556-77-IT
(EUCTR)
03/01/201511/11/2014A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
11EUCTR2014-002557-19-CZ
(EUCTR)
27/11/201430/09/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
12EUCTR2014-002556-77-CZ
(EUCTR)
27/11/201430/09/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy
13EUCTR2014-002557-19-HU
(EUCTR)
18/11/201409/10/2014A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 studyA Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study Subjects with moderate to severe crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
14EUCTR2014-002556-77-HU
(EUCTR)
18/11/201409/10/2014A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s DiseaseA Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease Subjects with moderate to severe crohn's disease
MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: MT-1303
Product Code: MT-1303
INN or Proposed INN: MT-1303
Mitsubishi Tanabe Pharma Corporation (MTPC)NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy
15NCT02148185
(ClinicalTrials.gov)
May 201420/5/2014Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's DiseaseA Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's DiseaseCrohn's DiseaseDrug: MT-1303Mitsubishi Tanabe Pharma CorporationNULLCompleted20 Years65 YearsBoth1Phase 1Japan

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
1JPRN-jRCT2031210352
28/02/202228/09/2021A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC)A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) Ulcerative ColitisDouble-blinded Treatment Period : Oral administration of 2 capsules of 0.2 mg or 0.4 mg amiselimod or placebo once a day for 2 weeks, and oral administration of one cupsule once a day for 10 weeks. Open Label Extension Period: Oral administration of 0.4 mg amiselimod once a day for up to 36 weeks.Kagiyama ShojiNULLRecruiting>= 18age old<= 75age oldBoth35Phase 2USA;Australia;Taiwan;S. Korea;Belarus;Russia;Ukraine;Moldova;Georgia;Germany;Hungary;Czech Republic;Slovakia,;Serbia;Italy;Estonia;Bulgaria;Poland;Japan
2NCT04857112
(ClinicalTrials.gov)
September 29, 202119/4/2021Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative ColitisA Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)Ulcerative ColitisDrug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: PlaceboBausch Health Americas, Inc.NULLRecruiting18 Years75 YearsAll336Phase 2United States
3EUCTR2020-005232-30-SK
(EUCTR)
17/08/202109/06/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) Ulcerative Colitis (UC)
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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Serbia;United States;Belarus;Czechia;Taiwan;Estonia;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Australia;Georgia;Bulgaria;Germany;Moldova, Republic of;Japan;Korea, Republic of
4EUCTR2020-005232-30-DE
(EUCTR)
05/08/202129/04/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) Ulcerative Colitis (UC)
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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;France;Hungary;Poland;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;New Zealand;Korea, Republic of
5EUCTR2020-005232-30-EE
(EUCTR)
27/07/202126/04/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) Ulcerative Colitis (UC)
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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Serbia;United States;Belarus;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of;Japan;Korea, Republic of
6EUCTR2020-005232-30-BG
(EUCTR)
22/06/202102/06/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) Ulcerative Colitis (UC)
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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Belarus;Serbia;United States;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of
7EUCTR2020-005232-30-HU
(EUCTR)
21/06/202123/04/2021Effects of Amiselimod in patients with mild to moderate Ulcerative Colitis.A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) Ulcerative Colitis (UC)
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: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Product Name: Amiselimod
Product Code: MT-1303
INN or Proposed INN: amiselimod
Other descriptive name: MT-1303
Salix Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
336Phase 2Belarus;Serbia;United States;Czechia;Estonia;Taiwan;Slovakia;Ukraine;Russian Federation;Italy;Hungary;Poland;Belgium;Australia;Bulgaria;Georgia;Germany;Japan;Moldova, Republic of;Korea, Republic of