44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details
臨床試験数 : 92 / 薬物数 : 106 - (DrugBank : 27) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 78
| 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 | EUCTR2014-003162-25-BE (EUCTR) | 06/07/2015 | 01/06/2015 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy) | Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) MedDRA version: 20.0;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 20.0;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 20.0;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 20.1;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10056218;Term: Necrotising granulomatous vasculitis;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 MedDRA version: 20.0;Classification code 10036023;Term: Polyangiitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB-240563 (mepolizumab) Product Code: SB-240563 (mepolizumab) INN or Proposed INN: Mepolizumab Other descriptive name: MEPOLIZUMAB | GlaxoSmithKline Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 115 | Phase 3 | United States;Canada;Belgium;Germany;United Kingdom;Japan | ||
| 2 | EUCTR2014-003162-25-GB (EUCTR) | 19/03/2015 | 22/01/2015 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy) | Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) MedDRA version: 20.0;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 20.0;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 20.0;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 20.1;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10056218;Term: Necrotising granulomatous vasculitis;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 MedDRA version: 20.0;Classification code 10036023;Term: Polyangiitis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB-240563 (mepolizumab) Product Code: SB-240563 (mepolizumab) INN or Proposed INN: Mepolizumab Other descriptive name: MEPOLIZUMAB | GlaxoSmithKline Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Canada;Belgium;Germany;Japan;United Kingdom | ||
| 3 | EUCTR2014-003162-25-DE (EUCTR) | 26/02/2015 | 09/12/2014 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 | Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy) | Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) MedDRA version: 20.0;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 21.1;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 21.0;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 20.1;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 21.1;Classification code 10056218;Term: Necrotising granulomatous vasculitis;System Organ Class: 100000004866 MedDRA version: 21.1;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 MedDRA version: 21.1;Classification code 10036023;Term: Polyangiitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB-240563 (mepolizumab) Product Code: SB-240563 (mepolizumab) INN or Proposed INN: Mepolizumab Other descriptive name: MEPOLIZUMAB | GlaxoSmithKline Research Ltd | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 3 | France;Canada;Belgium;Germany;United Kingdom;Japan | ||
| 4 | EUCTR2012-004385-17-ES (EUCTR) | 28/01/2014 | 05/12/2013 | Study of mepolizumab versus placebo in addition to standard of care for the treatment of Eosinophilic Granulomatosis with Polyangiitis. | A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. | Treatment of Eosinophilic Granulomatosis with Polyangiitis inSubjects Receiving Standard of Care Therapy. MedDRA version: 14.1;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 14.1;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 14.1;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 14.1;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 14.1;Classification code 10056218;Term: Necrotising granulomatous vasculitis;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10036023;Term: Polyangiitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Mepolizumab Product Code: SB-240563 INN or Proposed INN: Mepolizumab Other descriptive name: Recombinant humanized monoclonal antibody specific for human IL-5 | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom | ||
| 5 | EUCTR2012-004385-17-DE (EUCTR) | 07/01/2014 | 25/10/2013 | Study of mepolizumab versus placebo in addition to standard of care for the treatment of Eosinophilic Granulomatosis with Polyangiitis. | A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. | Treatment of Eosinophilic Granulomatosis with Polyangiitis inSubjects Receiving Standard of Care Therapy. MedDRA version: 20.0;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000018094 MedDRA version: 20.0;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000109234 MedDRA version: 20.0;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000140455 MedDRA version: 20.0;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000171039 MedDRA version: 20.0;Classification code 10056218;Term: Necrotising granulomatous vasculitis;Classification code 10036023;Term: Polyangiitis;System Organ Class: 100000023163 MedDRA version: 20.0;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000015470;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Mepolizumab Product Code: SB-240563 INN or Proposed INN: Mepolizumab Other descriptive name: Recombinant humanized monoclonal antibody specific for human IL-5 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom | ||
| 6 | EUCTR2012-004385-17-IT (EUCTR) | 02/01/2014 | 11/11/2013 | A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. | A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. | Treatment of Eosinophilic Granulomatosis with Polyangiitis inSubjects Receiving Standard of Care Therapy. MedDRA version: 16.1;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 16.1;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 16.1;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 16.1;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 16.1;Classification code 10056218;Term: Necrotising granulomatous vasculitis;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10036023;Term: Polyangiitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Mepolizumab Product Code: SB-240563 INN or Proposed INN: Mepolizumab Other descriptive name: Recombinant humanized monoclonal antibody specific for human IL-5 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;France;Canada;Spain;Belgium;Germany;United Kingdom;Japan;Italy | ||
| 7 | EUCTR2012-004385-17-GB (EUCTR) | 12/12/2013 | 30/10/2013 | Study of mepolizumab versus placebo in addition to standard of care for the treatment of Eosinophilic Granulomatosis with Polyangiitis. | A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. | Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. MedDRA version: 19.0;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 19.0;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 19.0;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 19.0;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 19.0;Classification code 10056218;Term: Necrotising granulomatous vasculitis;Classification code 10036023;Term: Polyangiitis;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Nucala Product Name: Mepolizumab Product Code: SB-240563 INN or Proposed INN: Mepolizumab Other descriptive name: Recombinant humanized monoclonal antibody specific for human IL-5 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom | ||
| 8 | EUCTR2012-004385-17-BE (EUCTR) | 22/11/2013 | 04/10/2013 | Study of mepolizumab versus placebo in addition to standard of care for the treatment of Eosinophilic Granulomatosis with Polyangiitis. | A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy. | Treatment of Eosinophilic Granulomatosis with Polyangiitis inSubjects Receiving Standard of Care Therapy. MedDRA version: 17.1;Level: LLT;Classification code 10018701;Term: Granulomatous disease;System Organ Class: 100000004867 MedDRA version: 17.1;Classification code 10014956;Term: Eosinophilic granuloma;System Organ Class: 100000004864 MedDRA version: 17.1;Classification code 10072580;Term: Granulomatous polyangiitis;System Organ Class: 100000004866 MedDRA version: 17.1;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870 MedDRA version: 17.1;Classification code 10056218;Term: Necrotising granulomatous vasculitis;Classification code 10068462;Term: Eosinophilic asthma;System Organ Class: 100000004855 MedDRA version: 17.1;Classification code 10036023;Term: Polyangiitis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Mepolizumab Product Code: SB-240563 INN or Proposed INN: Mepolizumab Other descriptive name: Recombinant humanized monoclonal antibody specific for human IL-5 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Spain;Belgium;Germany;Japan;Italy;United Kingdom |