Vilobelimab ( DrugBank: Vilobelimab )


2 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4
44多発血管炎性肉芽腫症4

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
1EUCTR2018-000768-27-DE
(EUCTR)
11/03/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
2EUCTR2018-000768-27-NL
(EUCTR)
10/03/201920/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Germany;Netherlands;United Kingdom;Italy;Sweden
3EUCTR2018-000768-27-SE
(EUCTR)
08/02/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2Spain;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Czechia;Sweden
4EUCTR2018-000768-27-CZ
(EUCTR)
10/01/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden

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
1EUCTR2018-000768-27-DE
(EUCTR)
11/03/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
2EUCTR2018-000768-27-NL
(EUCTR)
10/03/201920/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Germany;Netherlands;United Kingdom;Italy;Sweden
3EUCTR2018-000768-27-SE
(EUCTR)
08/02/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2Spain;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Czechia;Sweden
4EUCTR2018-000768-27-CZ
(EUCTR)
10/01/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden