Blisibimod ( DrugBank: Blisibimod )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
43顕微鏡的多発血管炎1
44多発血管炎性肉芽腫症1
49全身性エリテマトーデス3
63特発性血小板減少性紫斑病1
66IgA腎症8

43. 顕微鏡的多発血管炎


臨床試験数 : 88 薬物数 : 81 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 90
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01598857
(ClinicalTrials.gov)
December 201411/5/2012BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisA Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 2NULL

44. 多発血管炎性肉芽腫症


臨床試験数 : 98 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01598857
(ClinicalTrials.gov)
December 201411/5/2012BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisA Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 2NULL

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02514967
(ClinicalTrials.gov)
June 201631/7/2015CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLTerminated18 YearsN/AAll3Phase 3Georgia
2NCT02074020
(ClinicalTrials.gov)
December 201526/2/2014CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without NephritisA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without NephritisSystemic Lupus ErythematosusDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
3NCT01395745
(ClinicalTrials.gov)
February 201314/7/2011CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLCompleted18 YearsN/AAll442Phase 3Belarus;Brazil;Colombia;Georgia;Guatemala;Hong Kong;India;Korea, Republic of;Malaysia;Mexico;Philippines;Russian Federation;Singapore;Sri Lanka;Taiwan;Thailand

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01609452
(ClinicalTrials.gov)
December 201523/5/2012MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITPMONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP)Immune Thrombocytopenic Purpura;Idiopathic Thrombocytopenic PurpuraBiological: Blisibimod;Other: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 Years75 YearsBoth0Phase 2/Phase 3NULL

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001365-26-IT
(EUCTR)
05/06/201523/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
2EUCTR2014-001365-26-ES
(EUCTR)
27/05/201527/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Portugal;Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
3EUCTR2014-001365-26-HU
(EUCTR)
11/05/201525/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 17.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Belarus;Portugal;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Netherlands;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Georgia;Bulgaria;Germany;Japan;Sweden
4EUCTR2014-001365-26-SE
(EUCTR)
11/05/201525/03/2015A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 18.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2/3Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
5EUCTR2014-001365-26-DE
(EUCTR)
02/02/201507/08/2014A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 19.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Belarus;Philippines;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Italy;France;Malaysia;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Georgia;Germany;Japan;Sweden
6NCT02052219
(ClinicalTrials.gov)
October 201429/1/2014BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyIgA NephropathyDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 3NULL
7EUCTR2014-001365-26-CZ
(EUCTR)
21/08/201422/05/2014A study to evaluate the safety and efficacy of Blisibimod in IgA NephropathyA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects with IgA Nephropathy - BRIGHT-SC: Blisibimod Response in IGA following at-Home Treatment by Subcutaneous Administration IgA Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Blisibimod Injection
Product Code: A-623 or AMG 623
INN or Proposed INN: blisibimod
Anthera Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Philippines;Taiwan;Hong Kong;Spain;Thailand;United Kingdom;Italy;Hungary;Czech Republic;Canada;Malaysia;Singapore;Germany;Japan;Sweden;Korea, Republic of
8NCT02062684
(ClinicalTrials.gov)
June 201312/2/2014BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous AdministrationA Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA NephropathyIgA NephropathyDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLCompleted18 Years65 YearsAll57Phase 2/Phase 3Czechia;Germany;Hong Kong;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand;United Kingdom;Canada;Czech Republic;Italy;Russian Federation;Spain