DDrare: Database of Drug Development for Rare 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	4

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	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
2	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
3	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
4	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

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

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.

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

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.

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

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.

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