44. 多発血管炎性肉芽腫症
[臨床試験数:84,薬物数:88(DrugBank:22),標的遺伝子数:13,標的パスウェイ数:37

Searched query = "Wegener granulomatosis", "Multiple vasculitis granulomatous disease", "Granulomatosis with polyangiitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
15 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001832-77-DE
(EUCTR)
15/01/202021/08/2019Efficacy 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;France;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy
2JPRN-JapicCTI-195049
24/12/201926/11/2019MANDARAA 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 VasculitisIntervention 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 KKNULLrecruiting18BOTH6Phase 3Japan, North America, Europe
3EUCTR2019-001832-77-FR
(EUCTR)
23/12/201902/08/2019A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom
4NCT04157348
(ClinicalTrials.gov)
October 29, 201929/9/2019Efficacy 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 TherapyEosinophilic Granulomatous VasculitisBiological: Benralizumab;Biological: Mepolizumab;Biological: Placebo to Mepolizumab;Biological: Placebo to BenralizumabAstraZenecaNULLRecruiting18 Years130 YearsAll140Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom
5EUCTR2019-001832-77-GB
(EUCTR)
20/08/201922/10/2020Efficacy 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2014-003162-25-BE
(EUCTR)
06/07/201501/06/2015Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Mepolizumab 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
115Phase 3United States;Canada;Belgium;Germany;United Kingdom;Japan
7NCT03298061
(ClinicalTrials.gov)
April 14, 201527/9/2017Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921Mepolizumab 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 SyndromeDrug: Mepolizumab;Drug: PrednisoloneGlaxoSmithKlineNULLActive, not recruiting18 YearsN/AAll104Phase 3United States;Belgium;Canada;France;Germany;Japan;United Kingdom
8EUCTR2014-003162-25-GB
(EUCTR)
19/03/201522/01/2015Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Mepolizumab 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 LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
42Phase 3France;Canada;Belgium;Germany;Japan;United Kingdom
9EUCTR2014-003162-25-DE
(EUCTR)
26/02/201509/12/2014Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921Mepolizumab 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
115Phase 3France;Canada;Belgium;Germany;United Kingdom;Japan
10NCT02020889
(ClinicalTrials.gov)
February 5, 201419/12/2013A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With PolyangiitisA 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 TherapyChurg-Strauss SyndromeBiological: Mepolizumab;Drug: PlaceboGlaxoSmithKlineNational Institute of Allergy and Infectious Diseases (NIAID)Completed18 YearsN/AAll136Phase 3United States;Belgium;Canada;France;Germany;Italy;Japan;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-004385-17-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
12EUCTR2012-004385-17-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
13EUCTR2012-004385-17-IT
(EUCTR)
02/01/201411/11/2013Study 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: 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130United States;France;Canada;Spain;Belgium;Germany;United Kingdom;Japan;Italy
14EUCTR2012-004385-17-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]
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
130Phase 3France;United States;Canada;Belgium;Spain;Germany;Japan;Italy;United Kingdom
15EUCTR2012-004385-17-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