45. 好酸球性多発血管炎性肉芽腫症 Eosinophilic granulomatosis with Polyangiitis Clinical trials / Disease details
臨床試験数 : 31 / 薬物数 : 44 - (DrugBank : 18) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 101
| 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 | EUCTR2021-005726-15-NL (EUCTR) | 02/12/2022 | 15/09/2022 | A study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) | A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy - OCEAN | Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy MedDRA version: 20.0;Level: PT;Classification code 10078117;Term: Eosinophilic granulomatosis with polyangiitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Depemokimab Product Code: GSK3511294 INN or Proposed INN: Depemokimab Trade Name: Nucala Product Name: Mepolizumab INN or Proposed INN: Mepolizumab Other descriptive name: Anti-interleukin 5 (IL-5) humanized monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Czechia;Finland;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2021-005726-15-HU (EUCTR) | 12/07/2022 | 24/05/2022 | A study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) | A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy - OCEAN | Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy MedDRA version: 20.0;Level: PT;Classification code 10078117;Term: Eosinophilic granulomatosis with polyangiitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Depemokimab Product Code: GSK3511294 INN or Proposed INN: Depemokimab Trade Name: Nucala Product Name: Mepolizumab INN or Proposed INN: Mepolizumab Other descriptive name: Anti-interleukin 5 (IL-5) humanized monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Czechia;Finland;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Belgium;Poland;Brazil;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 3 | EUCTR2021-005726-15-ES (EUCTR) | 17/05/2022 | 04/03/2022 | A study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) | A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy - OCEAN | Relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy MedDRA version: 20.0;Level: PT;Classification code 10078117;Term: Eosinophilic granulomatosis with polyangiitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Depemokimab Product Code: GSK3511294 INN or Proposed INN: Depemokimab Trade Name: Nucala Product Name: Mepolizumab INN or Proposed INN: Mepolizumab Other descriptive name: Anti-interleukin 5 (IL-5) humanized monoclonal | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 3 | United States;Czechia;Finland;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Belgium;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 4 | EUCTR2019-001832-77-IT (EUCTR) | 25/02/2020 | 15/06/2021 | A study to evaluate if benralizumab compared to mepolizumab may be beneficial in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy - NA | Eosinophilic Granulomatosis with Polyangiitis (EGPA) MedDRA version: 20.1;Level: LLT;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: NUCALA Product Name: mepolizumab Product Code: [L04AC06] INN or Proposed INN: Mepolizumab Product Name: benralizumab Product Code: [MEDI-563] INN or Proposed INN: benralizumab | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy | ||
| 5 | EUCTR2019-001832-77-DE (EUCTR) | 15/01/2020 | 21/08/2019 | Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab. | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy | Eosinophilic Granulomatosis with Polyangiitis (EGPA) MedDRA version: 20.1;Level: LLT;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: Benralizumab Trade Name: Nucala 100 mg powder for solution for injection Product Name: mepolizumab Product Code: L04AC06 INN or Proposed INN: Mepolizumab Other descriptive name: Nucala | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Canada;Belgium;Israel;Germany;United Kingdom;Italy;Japan | ||
| 6 | EUCTR2019-001832-77-FR (EUCTR) | 23/12/2019 | 02/08/2019 | A study to evaluate if benralizumab compared to mepolizumab may be beneficial in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy | Eosinophilic Granulomatosis with Polyangiitis (EGPA);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: Benralizumab Trade Name: NUCALA Product Name: mepolizumab Product Code: L04AC06 INN or Proposed INN: Mepolizumab Other descriptive name: Nucala | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom | ||
| 7 | EUCTR2019-001832-77-GB (EUCTR) | 20/08/2019 | 22/10/2020 | Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab. | A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy. | Eosinophilic Granulomatosis with Polyangiitis (EGPA);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: Benralizumab Trade Name: NUCALA Product Name: NUCALA Product Code: L04AC06 INN or Proposed INN: Mepolizumab Other descriptive name: Nucala | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom | ||
| 8 | 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 | ||
| 9 | NCT03298061 (ClinicalTrials.gov) | April 14, 2015 | 27/9/2017 | Long-term Access Program (LAP) of Mepolizumab 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) | Churg-Strauss Syndrome | Drug: Mepolizumab;Drug: Prednisolone | GlaxoSmithKline | NULL | Active, not recruiting | 18 Years | N/A | All | 104 | Phase 3 | United States;Belgium;Canada;France;Germany;Japan;United Kingdom |
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | NCT02020889 (ClinicalTrials.gov) | February 5, 2014 | 19/12/2013 | A Study to Investigate Mepolizumab in 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 | Churg-Strauss Syndrome | Biological: Mepolizumab;Drug: Placebo | GlaxoSmithKline | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | 18 Years | N/A | All | 136 | Phase 3 | United States;Belgium;Canada;France;Germany;Italy;Japan;Spain;United Kingdom |
| 13 | NCT00716651 (ClinicalTrials.gov) | July 2008 | 14/7/2008 | Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome | A Phase II, Single Center Open Label, Prospective Trial to Evaluate the Efficacy and Safety of Mepolizumab for Patients With Refractory or Relapsing Churg Strauss Syndrome | Churg Strauss Syndrome | Drug: mepolizumab | University of Schleswig-Holstein | GlaxoSmithKline | Completed | 18 Years | 80 Years | Both | 10 | Phase 2 | Germany |
| 14 | EUCTR2006-001791-20-DE (EUCTR) | 30/06/2008 | 02/01/2008 | A Phase II, single center open label, prospective trial to evaluate the efficacy and safety of mepolizumab for patients with refractory or relapsing Churg Strauss Syndrome - MEPOCHUSS | A Phase II, single center open label, prospective trial to evaluate the efficacy and safety of mepolizumab for patients with refractory or relapsing Churg Strauss Syndrome - MEPOCHUSS | Churg-Strauss-Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10009164;Term: Churg Strauss syndrome | Product Name: Mepolizumab Product Code: SB-240563 | University Hospital of Schleswig-Holstein (UKSH), Campus Lübeck | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany | |||
| 15 | NCT00527566 (ClinicalTrials.gov) | September 2007 | 7/9/2007 | Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome | Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome | Churg Strauss Syndrome | Biological: Mepolizumab | Brigham and Women's Hospital | GlaxoSmithKline | Completed | 19 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| 16 | NCT00266565 (ClinicalTrials.gov) | December 2001 | 15/12/2005 | Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome | A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes | Hypereosinophilic Syndromes;Eosinophilic Gastroenteritis;Churg-Strauss Syndrome;Eosinophilic Esophagitis | Drug: Mepolizumab | Children's Hospital Medical Center, Cincinnati | NULL | Completed | 18 Years | 65 Years | All | 24 | Phase 1/Phase 2 | United States |