Mepolizumab (DrugBank: Mepolizumab)
4 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 44 | 多発血管炎性肉芽腫症 | 15 |
| 45 | 好酸球性多発血管炎性肉芽腫症 | 12 |
| 98 | 好酸球性消化管疾患 | 4 |
| 162 | 類天疱瘡（後天性表皮水疱症を含む。） | 1 |
| 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 | 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] | 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 | United States;France;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy | ||
| 2 | JPRN-JapicCTI-195049 | 24/12/2019 | 26/11/2019 | MANDARA | 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 Granulomatous Vasculitis | Intervention name : Biological: Benralizumab, Biological: Placebo to Mepolizumab INN of the intervention : - Dosage And administration of the intervention : 1x benralizumab SC injection + 3x placebo to mepolizumab SC injections Control intervention name : Biological: Mepolizumab, Biological: Placebo to Benralizumab INN of the control intervention : - Dosage And administration of the control intervention : 3x mepolizumab SC injections + 1x placebo to benralizumab SC injection | AstraZeneca KK | NULL | recruiting | 18 | BOTH | 6 | Phase 3 | Japan, North America, Europe | |
| 3 | 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 | ||
| 4 | NCT04157348 (ClinicalTrials.gov) | October 29, 2019 | 29/9/2019 | 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 Granulomatous Vasculitis | Biological: Benralizumab;Biological: Mepolizumab;Biological: Placebo to Mepolizumab;Biological: Placebo to Benralizumab | AstraZeneca | NULL | Recruiting | 18 Years | 130 Years | All | 140 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom |
| 5 | 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 | ||
| 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 |
| 6 | 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 | ||
| 7 | 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 |
| 8 | 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] | GlaxoSmithKline Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France;Canada;Belgium;Germany;Japan;United Kingdom | |||
| 9 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 115 | Phase 3 | France;Canada;Belgium;Germany;United Kingdom;Japan | ||
| 10 | 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 |
| 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 |
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | EUCTR2012-004385-17-IT (EUCTR) | 02/01/2014 | 11/11/2013 | 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: 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | United States;France;Canada;Spain;Belgium;Germany;United Kingdom;Japan;Italy | |||
| 14 | 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] | 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 | |||
| 15 | 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 |
| 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 | 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] | 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 | United States;France;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |
| 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 |
| 6 | 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] | GlaxoSmithKline Research Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 3 | France;Canada;Belgium;Germany;Japan;United Kingdom | |||
| 7 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 115 | Phase 3 | France;Canada;Belgium;Germany;United Kingdom;Japan | ||
| 8 | 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 |
| 9 | 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 |
| 10 | 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 | |||
| 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 |
| 11 | 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 |
| 12 | 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 |
| 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 | NCT03656380 (ClinicalTrials.gov) | March 20, 2019 | 30/8/2018 | Mepo for EoE Study | A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms | EoE;Eosinophilic Esophagitis | Drug: Mepolizumab 300 mg;Drug: Mepolizumab 100 mg;Other: Placebo | University of North Carolina, Chapel Hill | GlaxoSmithKline;University of Utah;Northwestern University;MNGI Digestive Health, P.A. | Recruiting | 16 Years | 75 Years | All | 72 | Phase 2 | United States |
| 2 | NCT00358449 (ClinicalTrials.gov) | September 11, 2006 | 27/7/2006 | Intravenous Mepolizumab In Children With Eosinophilic Esophagitis | A Randomized, Double-blind, Parallel Group Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Mepolizumab (SB240563)(0.55mg/kg, 2.5mg/kg or 10mg/kg) in Pediatric Subjects With Eosinophilic Esophagitis, Aged 2 to 17 Years (Study MEE103219) | Oesophagitis, Eosinophilic | Drug: mepolizumab | GlaxoSmithKline | NULL | Completed | 2 Years | 17 Years | All | 84 | Phase 2 | United States;Australia;Canada;United Kingdom |
| 3 | EUCTR2005-006074-10-GB (EUCTR) | 15/06/2006 | 07/02/2006 | A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitis | A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitis | Eosinophilic oesophagitis | GlaxoSmithKline Research & Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | United Kingdom | |||
| 4 | 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 |
| 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 | NCT01705795 (ClinicalTrials.gov) | February 13, 2013 | 5/10/2012 | Anti-IL-5 Therapy in Bullous Pemphigoid (BP) | Anti-IL-5 Therapy in Bullous Pemphigoid. Randomized, Placebo-controlled, Double-blind Study Evaluating the Effect of Anti-IL-5 Therapy in Patients With Bullous Pemphigoid. | Pemphigoid, Bullous | Drug: Mepolizumab (a-IL-5 antibody);Drug: Placebo | University Hospital Inselspital, Berne | NULL | Completed | 18 Years | N/A | All | 32 | Phase 2 | Switzerland |