ALXN2050 ( DrugBank: - )


2 diseases
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3
62発作性夜間ヘモグロビン尿症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
Target_
size
PhaseCountries
1EUCTR2021-001229-26-ES
(EUCTR)
21/01/202214/12/2021Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis 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] - Immune System Diseases [C20]
Product Name: ALXN2050
INN or Proposed INN: N/A
Other descriptive name: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide
Alexion PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Taiwan;Canada;Spain;Korea, Democratic People's Republic of;Germany;Italy
2NCT05218096
(ClinicalTrials.gov)
December 30, 202116/12/2021Study of ALXN2050 in Adult Participants With Generalized Myasthenia GravisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Generalized Myasthenia GravisGeneralized Myasthenia Gravis;Myasthenia GravisDrug: ALXN2050;Drug: PlaceboAlexion PharmaceuticalsNULLRecruiting18 YearsN/AAll70Phase 2United States;Canada;Germany;Italy;Korea, Republic of;Spain;Taiwan
3EUCTR2021-001229-26-IT
(EUCTR)
21/12/202119/10/2021Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants withGeneralized Myasthenia Gravis - - 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] - Immune System Diseases [C20]
Trade Name: Menveo
Product Name: Menveo
Product Code: [N/A]
INN or Proposed INN: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
INN or Proposed INN: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 ADSORBED ON ALUMINUM HYDROXIDE
Other descriptive name: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO
INN or Proposed INN: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
INN or Proposed INN: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN
Trade Name: Velamox
Product Name: Velamox
Product Code: [N/A]
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Taiwan;Canada;Spain;Germany;Italy;Korea, Republic of

62. 発作性夜間ヘモグロビン尿症


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003830-17-ES
(EUCTR)
02/11/202114/07/2021Study of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as MonotherapyA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy - Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN2050
Product Code: ALXN2050
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2France;Canada;Spain;Turkey;Germany;United Kingdom;Italy;New Zealand;Korea, Republic of
2EUCTR2019-003830-17-IT
(EUCTR)
13/10/202123/06/2020Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 InhibitorA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background Therapy Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Achillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2United States;Spain;United Kingdom;New Zealand;Italy;Korea, Republic of
3EUCTR2019-003830-17-GB
(EUCTR)
16/09/202016/06/2020Study of the Oral Factor D (fD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with background use of an Approved C5 InhibitorA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ACH-0145228 in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as Monotherapy and with an Approved C5 Inhibitor as Background Therapy Paroxysmal Nocturnal Hemoglobinuria (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Product Name: ALXN2050
Product Code: ACH-0145228
INN or Proposed INN: N/A
Other descriptive name: ACH-0145228
Achillion Pharmaceuticals, Inc., a wholly owned subsidiary of Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 2United States;New Zealand;Italy;United Kingdom;Korea, Republic of
4NCT04170023
(ClinicalTrials.gov)
December 16, 20196/11/2019Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as MonotherapyA Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of the Oral Factor D (FD) Inhibitor ALXN2050 (ACH-0145228) in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients as MonotherapyParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: ALXN2050Alexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll26Phase 2Canada;Italy;Korea, Republic of;New Zealand;Spain;Turkey;United Kingdom;Germany;United States