JNJ-67896153/ACT-128800 ( DrugBank: - )


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 : 3,340 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
1EUCTR2020-004431-24-DE
(EUCTR)
22/09/2022A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple SclerosisMulti-center, Randomized, Double-blind, Parallel-group, Double-dummy, Active-controlled, Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis - PIONEER 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]
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Trade Name: Ponvory
Product Name: Ponesimod
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
212Phase 3Serbia;Portugal;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Israel;Switzerland;Italy;France;Puerto Rico;Peru;Australia;Czechia;Finland;Turkey;Austria;United Kingdom;Hungary;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
2EUCTR2020-004431-24-PL
(EUCTR)
28/10/2022A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple SclerosisMulti-center, Randomized, Double-blind, Parallel-group, Double-dummy, Active-controlled, Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis - PIONEER 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: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN: Ponesimod
Other descriptive name: ACT-128800
Product Name: Ponesimod
Product Code: JNJ-67896153/ACT-128800
INN or Proposed INN:
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
212Phase 3Hungary;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden;Turkey;Austria;United Kingdom;Serbia;Portugal;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Israel;Switzerland;Italy;France;Puerto Rico;Peru;Australia;Czechia;Finland