Ozanimod HCI ( DrugBank: Ozanimod )


1 disease
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

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
1EUCTR2015-002500-91-PT
(EUCTR)
06/06/201613/04/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. - Open Label Extension (OLE) study 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: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
2EUCTR2015-002500-91-GR
(EUCTR)
18/11/201504/11/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study 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: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden