PredniSONE Tablets, USP ( DrugBank: Prednisone )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 41 | 巨細胞性動脈炎 | 10 |
| 43 | 顕微鏡的多発血管炎 | 10 |
| 44 | 多発血管炎性肉芽腫症 | 10 |
41. 巨細胞性動脈炎
臨床試験数 : 131 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
| 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 | EUCTR2020-004809-31-SE (EUCTR) | 11/01/2022 | 21/10/2021 | Study of efficacy and safety of secukinumab 300 mg and 150 mg in patients with giant cell arteritis (GCA). | A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cell arteritis (GCA) | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cosentyx 300 mg solution for injection in pre-filled syringe INN or Proposed INN: SECUKINUMAB Trade Name: PredniSONE Tablets, USP, 1 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 2.5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets, USP 10 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 348 | Phase 3 | United States;Portugal;Estonia;Spain;Russian Federation;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Czechia;Finland;Guatemala;Turkey;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 2 | EUCTR2018-001003-36-HR (EUCTR) | 10/04/2019 | 17/05/2019 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 3 | EUCTR2018-001003-36-DE (EUCTR) | 27/02/2019 | 21/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 4 | EUCTR2018-001003-36-GB (EUCTR) | 06/12/2018 | 20/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: Prednisone Tablets, USP Product Code: N/A INN or Proposed INN: n/a Other descriptive name: PREDNISONE | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 5 | EUCTR2018-001003-36-IT (EUCTR) | 30/11/2018 | 11/10/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;Italy;United Kingdom;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 6 | EUCTR2018-001003-36-BE (EUCTR) | 28/11/2018 | 16/08/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Poland;Belgium;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 7 | EUCTR2018-001003-36-NL (EUCTR) | 13/11/2018 | 29/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 23.1;Level: PT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Serbia;United States;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Netherlands;Germany;New Zealand | ||
| 8 | EUCTR2018-001003-36-SI (EUCTR) | 03/10/2018 | 30/08/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 9 | EUCTR2018-001003-36-ES (EUCTR) | 08/08/2018 | 28/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand | ||
| 10 | EUCTR2018-001003-36-EE (EUCTR) | 09/07/2018 | 11/06/2018 | A clinical study to test treatment of KPL-301 compared to placebo in giant cell arteritis | A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis | giant cell arteritis MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavrilimumab Product Code: KPL-301 INN or Proposed INN: MAVRILIMUMAB Other descriptive name: n/a Trade Name: Prednisone Tablets, USP Product Name: PredniSONE Tablets, USP Product Code: N/A | Kiniksa Pharmaceuticals, Ltd. (Hamilton, Bermuda) c/o Kiniksa Pharmaceuticals Corp. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Serbia;Estonia;Slovenia;Spain;Ireland;United Kingdom;Italy;Belgium;Poland;Croatia;Australia;Germany;Netherlands;New Zealand |
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. | 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-GB (EUCTR) | 17/04/2019 | 27/12/2018 | 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) - InflaRx GmbH_IFX-1-P2.5 | 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: PredniSONE Tablets, USP INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |
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. | 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-GB (EUCTR) | 17/04/2019 | 27/12/2018 | 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) - InflaRx GmbH_IFX-1-P2.5 | 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: PredniSONE Tablets, USP INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |