Tolebrutininb ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症4

11. 重症筋無力症


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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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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
2NCT05132569
(ClinicalTrials.gov)
December 3, 202112/11/2021Efficacy 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 GravisDrug: Tolebrutininb;Drug: PlaceboSanofiNULLTerminated18 Years85 YearsAll6Phase 3United States;Canada;China;Hungary;Italy;Japan;Poland;Spain;United Kingdom
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