Recombinant humanized monoclonal antibody specific for human IL-5 ( DrugBank: - )


1 disease
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5

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.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2012-004385-17-ES
(EUCTR)
28/01/201405/12/2013Study 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.NULLNot RecruitingFemale: yes
Male: yes
130Phase 3France;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom
2EUCTR2012-004385-17-DE
(EUCTR)
07/01/201425/10/2013Study 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 LtdNULLNot RecruitingFemale: yes
Male: yes
130Phase 3France;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom
3EUCTR2012-004385-17-IT
(EUCTR)
02/01/201411/11/2013A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
130Phase 3United States;France;Canada;Spain;Belgium;Germany;United Kingdom;Japan;Italy
4EUCTR2012-004385-17-GB
(EUCTR)
12/12/201330/10/2013Study 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 LtdNULLNot 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): noFrance;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom
5EUCTR2012-004385-17-BE
(EUCTR)
22/11/201304/10/2013Study 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 LtdNULLNot RecruitingFemale: yes
Male: yes
130Phase 3France;United States;Canada;Spain;Belgium;Germany;Japan;Italy;United Kingdom