Latozinemab ( DrugBank: Latozinemab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
127前頭側頭葉変性症4

127. 前頭側頭葉変性症


臨床試験数 : 90 薬物数 : 87 - (DrugBank : 30) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 88
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004066-18-SE
(EUCTR)
06/10/202010/06/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: Latozinemab
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
2EUCTR2019-004066-18-BE
(EUCTR)
31/07/202026/05/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: Latozinemab
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
3EUCTR2019-004066-18-DE
(EUCTR)
06/07/202020/02/2020A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTDA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: Latozinemab
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;Spain;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden;United States
4EUCTR2019-000138-20-DE
(EUCTR)
08/10/201927/05/2019An Open-Label Study to Evaluate Safety of long-term AL001 dosing in FTDA Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia Frontotemporal Dementia
MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AL001
Product Code: AL001
INN or Proposed INN: Latozinemab
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Netherlands;Germany;United Kingdom;Italy