11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003898-59-ES
(EUCTR)
12/01/202214/10/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Poland;Spain;Russian Federation;Germany;United Kingdom;Italy;Japan;China
2EUCTR2021-003898-59-PL
(EUCTR)
11/01/202225/11/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutinib
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;China;Japan
3EUCTR2021-003898-59-HU
(EUCTR)
30/11/202104/12/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - URSA Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;Italy;China
4EUCTR2021-003898-59-IT
(EUCTR)
12/11/202106/10/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - . Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: [SAR442168]
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;China;Italy