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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-000768-27-IE (EUCTR) | 26/08/2019 | 20/12/2018 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2018-000768-27-DK (EUCTR) | 05/08/2019 | 20/03/2019 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2018-000768-27-BE (EUCTR) | 04/04/2019 | 01/05/2019 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2018-000768-27-DE (EUCTR) | 11/03/2019 | 19/12/2018 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2018-000768-27-NL (EUCTR) | 10/03/2019 | 20/12/2018 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 6 | EUCTR2018-000768-27-IT (EUCTR) | 27/02/2019 | 24/05/2021 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Czechia;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 7 | EUCTR2018-000768-27-SE (EUCTR) | 08/02/2019 | 19/12/2018 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Spain;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Czechia;Sweden | ||
| 8 | EUCTR2018-000768-27-ES (EUCTR) | 17/01/2019 | 18/01/2019 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Belgium;Spain;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 9 | EUCTR2018-000768-27-CZ (EUCTR) | 10/01/2019 | 19/12/2018 | Efficacy 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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 10 | NCT02198248 (ClinicalTrials.gov) | October 2014 | 18/7/2014 | Low-dose Glucocorticoid Vasculitis Induction Study | Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis | Drug: Rituximab;Drug: Glucocorticoids | Chiba University | NULL | Active, not recruiting | 20 Years | N/A | All | 140 | Phase 4 | Japan |
| 11 | NCT02169219 (ClinicalTrials.gov) | June 2014 | 19/6/2014 | Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis | Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Glucocorticoids;Drug: Rituximab | Massachusetts General Hospital | Genentech, Inc. | Completed | 18 Years | 85 Years | All | 20 | Phase 4 | United States |
| 12 | NCT01446211 (ClinicalTrials.gov) | November 2011 | 20/9/2011 | Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus Versus Conventional Therapy in Relapse of Granulomatosis With Polyangiitis (Wegener's Granulomatosis) SPARROW Study - SPAnidin in Relapsing GRanulomatosis With POlyangiitis Wegener's Granulomatosis) | Wegeners Granulomatosis | Drug: Gusperimus + glucocorticoids;Drug: cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids | Nordic Pharma SAS | NULL | Terminated | 18 Years | 75 Years | Both | 4 | Phase 3 | Czech Republic |
| 13 | NCT00987389 (ClinicalTrials.gov) | May 2010 | 23/9/2009 | Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis | Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial | Granulomatosis With Polyangiitis (Wegener's) (GPA);Microscopic Polyangiitis (MPA) | Procedure: Plasma Exchange;Other: No Plasma Exchange;Drug: Glucocorticoids [Standard Dose];Drug: Glucocorticoids [Reduced Dose] | University of Pennsylvania | Cambridge University Hospitals NHS Foundation Trust;University of Birmingham;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 15 Years | N/A | All | 704 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Denmark;France;Greece;Italy;Japan;Mexico;New Zealand;Norway;Sweden;United Kingdom;Czech Republic |
| 14 | NCT03919825 (ClinicalTrials.gov) | May 2010 | 15/4/2019 | Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - Glucocorticoids | Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial [Glucocorticoids] | Granulomatosis With Polyangiitis (Wegener's) (GPA);Microscopic Polyangiitis (MPA) | Drug: Glucocorticoids - Standard Dose;Drug: Glucocorticoids - Reduced Dose | University of Pennsylvania | NULL | Completed | 15 Years | N/A | All | 704 | Phase 3 | NULL |