44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details


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

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2018-000768-27-IE
(EUCTR)
26/08/201920/12/2018Efficacy 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: not yet available
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
81Phase 2Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
2EUCTR2018-000768-27-DK
(EUCTR)
05/08/201920/03/2019Efficacy 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: not yet available
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
81Phase 2Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
3EUCTR2018-000768-27-BE
(EUCTR)
04/04/201901/05/2019Efficacy 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: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;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: not yet available
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
81Phase 2France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
4EUCTR2018-000768-27-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
5EUCTR2018-000768-27-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
6EUCTR2018-000768-27-IT
(EUCTR)
27/02/201924/05/2021Efficacy 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) - Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients wit 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]
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
Product Code: [Glucocorticoids (GC)]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
Product Code: [Glucocorticoids (GC)]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Product Name: IFX-1
Product Code: [IFX-1]
INN or Proposed INN: not yet available
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
81Phase 2Czechia;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
7EUCTR2018-000768-27-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
8EUCTR2018-000768-27-ES
(EUCTR)
17/01/201918/01/2019Efficacy 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: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;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: not yet available
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
81Phase 2France;Czech Republic;Belgium;Spain;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
9EUCTR2018-000768-27-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