Non applicabile ( DrugBank: - )


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2
49全身性エリテマトーデス1
51全身性強皮症1
256筋型糖原病1

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
1EUCTR2019-004980-36-IT
(EUCTR)
31/08/202021/01/2021Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: [M2951]
INN or Proposed INN: Evobrutinib
Other descriptive name: MSC2364447C
Trade Name: Aubagio
Product Name: Aubagio
Product Code: [non applicabile]
INN or Proposed INN: TERIFLUNOMIDE
MERCK HEALTHCARE KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
2EUCTR2019-004972-20-IT
(EUCTR)
31/08/202021/01/2021Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib
Product Code: [M2951]
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: AUBAGIO
Product Name: Aubagio
Product Code: [non applicabile]
INN or Proposed INN: TERIFLUNOMIDE
MERCK HEALTHCARE KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Canada;Argentina;Poland;Belgium;Croatia;Georgia;Serbia;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Australia;Peru;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Bulgaria;Germany

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001567-25-IT
(EUCTR)
22/10/202112/10/2021Efficacy and safety of SAR441344 in the treatment of Systemic Lupus ErythematosusEfficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study - APATURA Systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: SAR441344
Product Code: [SAR441344]
INN or Proposed INN: NON APPLICABILE
Other descriptive name: SAR441344
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 2United States;Mexico;Greece;Argentina;Spain;Ukraine;Turkey;Russian Federation;Chile;Germany;Italy

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001028-80-IT
(EUCTR)
19/12/201605/11/2020Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisEfficacy and safety of SAR156597 in the treatment of diffuse cutaneous Systemic Sclerosis (dcSSc): A randomized, double-blind, placebo-controlled, 24-week, proof of concept study - NA Systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NA
Product Code: SAR156597
INN or Proposed INN: non applicabile
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLNot RecruitingFemale: yes
Male: yes
94Phase 2United States;Estonia;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Mexico;Argentina;Belgium;Poland;Romania;Germany

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 133 - (DrugBank : 29) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 105
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000755-40-IT
(EUCTR)
17/05/201925/01/2021A study investigating the efficacy and safety of intravenous (IV) ATB200 when Co-administrated with oral AT2221 in adult subjects with Pompe disease compared with Alglucosidase Alfa/Placebo.A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease Compared With Alglucosidase Alfa/Placebo - AMICUS ATB200-03 Adult Subjects With Late Onset Pompe Disease (LOPD)
MedDRA version: 20.0;Level: LLT;Classification code 10075702;Term: Pompe's disease late onset;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ATB200
Product Code: [ATB200]
INN or Proposed INN: non applicabile
Product Name: AT2221
Product Code: [AT2221]
INN or Proposed INN: MIGLUSTAT
Trade Name: Myozyme
Product Name: Myozyme
Product Code: [Myozyme]
INN or Proposed INN: ALGLUCOSIDASI ALFA UMANA RICOMBINANTE
AMICUS THERAPEUTICS, INC.NULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Taiwan;Slovakia;Greece;Spain;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Korea, Democratic People's Republic of;Austria;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden