AL001 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
127前頭側頭葉変性症16

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05053035
(ClinicalTrials.gov)
September 2, 20211/9/2021A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALSA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in C9orf72-Associated Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisDrug: AL001;Drug: PlaceboAlector Inc.NULLRecruiting18 YearsN/AAll45Phase 2United States

127. 前頭側頭葉変性症


臨床試験数 : 89 薬物数 : 104 - (DrugBank : 33) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 117
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-FR
(EUCTR)
04/02/202130/06/2020A 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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
2EUCTR2019-004066-18-GB
(EUCTR)
03/12/202025/09/2020A 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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
3EUCTR2019-004066-18-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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
4EUCTR2019-004066-18-NL
(EUCTR)
02/09/202003/03/2020A 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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
5EUCTR2019-004066-18-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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
6NCT04374136
(ClinicalTrials.gov)
July 23, 202023/4/2020A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)A 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 GeneFrontotemporal DementiaDrug: AL001;Drug: Placebo;Drug: Open label - AL001Alector Inc.NULLRecruiting25 Years85 YearsAll180Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Portugal;Spain;Sweden;Switzerland;United Kingdom
7EUCTR2019-004066-18-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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
8EUCTR2019-004066-18-PT
(EUCTR)
29/05/202021/02/2020A 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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
9EUCTR2019-004066-18-IT
(EUCTR)
18/05/202015/06/2021A Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AL001 in FTD.A 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. - NA 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: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Germany;Netherlands;Sweden;United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia
10EUCTR2019-004066-18-ES
(EUCTR)
22/04/202006/03/2020A 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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;France;Canada;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
11EUCTR2019-000138-20-GB
(EUCTR)
18/11/201921/05/2019An 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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United States;Canada;Netherlands;Germany;Italy;United Kingdom
12EUCTR2019-000138-20-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
13NCT03987295
(ClinicalTrials.gov)
September 27, 201914/5/2019A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)A 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 DementiaFrontotemporal DementiaDrug: AL001Alector Inc.NULLRecruiting18 Years85 YearsAll40Phase 2United States;Canada;Germany;Italy;Netherlands;United Kingdom
14EUCTR2019-000138-20-IT
(EUCTR)
24/09/201915/01/2021An 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]
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United States;Canada;Netherlands;Germany;United Kingdom;Italy
15EUCTR2019-000138-20-NL
(EUCTR)
20/09/201906/06/2019An 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: not available
Other descriptive name: AL001
Alector Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;Canada;Germany;Netherlands;United Kingdom;Italy
16NCT03636204
(ClinicalTrials.gov)
September 14, 201812/7/2018A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) MutationA First in Human Phase 1 Study in Healthy Volunteers and in Participants With Frontotemporal Dementia (FTD) With Granulin MutationHealthy;Frontotemporal DementiaBiological: AL001;Other: PlaceboAlector Inc.NULLCompleted18 Years80 YearsAll64Phase 1United States;Canada;United Kingdom;Netherlands