ANX005 ( DrugBank: ANX005 )


3 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
8ハンチントン病1
61自己免疫性溶血性貧血6

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 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
1EUCTR2021-000325-26-FR
(EUCTR)
29/04/202119/02/2021Phase 2 safety and tolerability study using ANX005 for ALSPhase 2a Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Intravenous ANX005 in Subjects with Amyotrophic Lateral Sclerosis Amyotrophic Lateral Scelrosis (ALS)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: IMMUNOGLOBULIN G
Annexon BiosciencesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;France;Canada

8. ハンチントン病


臨床試験数 : 242 薬物数 : 205 - (DrugBank : 62) / 標的遺伝子数 : 85 - 標的パスウェイ数 : 159
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04514367
(ClinicalTrials.gov)
August 17, 202027/7/2020An Open Label Study of ANX005 in Subjects With, or at Risk for, Manifest Huntington's DiseaseA Phase 2a Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ANX005 in Subjects With, or at Risk for, Manifest Huntington's DiseaseHuntington DiseaseDrug: ANX005Annexon, Inc.NULLCompleted18 YearsN/AAll28Phase 2United States

61. 自己免疫性溶血性貧血


臨床試験数 : 146 薬物数 : 131 - (DrugBank : 59) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 158
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04691570
(ClinicalTrials.gov)
November 10, 202128/12/2020Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous ANX005 in Subjects With Warm Autoimmune Hemolytic Anemia (wAIHA)Warm Autoimmune Hemolytic Anemia (wAIHA)Drug: ANX005Annexon, Inc.NULLCompleted18 YearsN/AAll6Phase 2United States
2EUCTR2020-003675-18-BG
(EUCTR)
28/10/202129/07/2021Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: ANX005
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2United States;France;Czechia;Spain;Austria;Australia;Bulgaria;Germany;Italy
3EUCTR2020-005854-90-AT
(EUCTR)
11/02/202105/01/2021Investigation of the influence of ANX005 on the body of patients with primary cold agglutinin disease in terms of safety and tolerability. A Phase 2, single-center, open-label, repeat-dose study.A Phase 2, Single-Center, Open-Label, Repeat-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Intravenous ANX005 in Participants with Primary Cold Agglutinin Disease Primary Cold Agglutinin Disease (CAD);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: Recombinant humanized IgG4 monoclonal antibody
Annexon, Inc.NULLNot RecruitingFemale: yes
Male: yes
6Phase 2Austria
4EUCTR2020-003675-18-AT
(EUCTR)
05/02/202110/12/2020Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: ANX005
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Czechia;Spain;Australia;Austria;Bulgaria;Germany;United Kingdom;Italy
5EUCTR2020-003675-18-DE
(EUCTR)
11/01/202128/09/2020Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia Warm Autoimmune Hemolytic Anemia
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Code: ANX005
INN or Proposed INN: ANX005
Other descriptive name: ANX005
Annexon, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;United States;Czechia;Spain;Austria;Australia;Bulgaria;Germany;Italy
6EUCTR2020-003675-18-IT
(EUCTR)
11/12/202002/08/2021Study to Assess the Safety, Tolerability, Efficacy, PK, PD and POC of Intravenous ANX005 in Patients With wAIHAA Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia - Study with intravenous ANX005 in patients with wAIHA warm autoimmune hemolytic anemia
MedDRA version: 20.0;Level: LLT;Classification code 10003825;Term: Autoimmune hemolytic anemia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: ANX005
Product Code: [ANX005]
Other descriptive name: Recombinant humanized monoclonal antibody: IgG4 (heavy chain); kappa (light chain)
Annexon, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Hungary;Spain;Austria;Norway;Netherlands;Germany;United Kingdom;Italy