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

  
16 trials found
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1EUCTR2021-005726-15-NL
(EUCTR)
02/12/202215/09/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
2EUCTR2021-005726-15-HU
(EUCTR)
12/07/202224/05/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
3EUCTR2021-005726-15-ES
(EUCTR)
17/05/202204/03/2022A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United 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
4EUCTR2019-001832-77-IT
(EUCTR)
25/02/202015/06/2021A 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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3France;United States;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy
5EUCTR2019-001832-77-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]
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 ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3France;United States;Canada;Belgium;Israel;Germany;United Kingdom;Italy;Japan
6EUCTR2019-001832-77-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
7EUCTR2019-001832-77-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
8EUCTR2014-003162-25-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
9NCT03298061
(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
10EUCTR2014-003162-25-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]
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 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): noFrance;Canada;Belgium;Germany;Japan;United Kingdom
11EUCTR2014-003162-25-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 LtdNULLNot RecruitingFemale: yes
Male: yes
115Phase 3France;Canada;Belgium;Germany;United Kingdom;Japan
12NCT02020889
(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
13NCT00716651
(ClinicalTrials.gov)
July 200814/7/2008Safety and Efficacy Study of Mepolizumab in Churg Strauss SyndromeA Phase II, Single Center Open Label, Prospective Trial to Evaluate the Efficacy and Safety of Mepolizumab for Patients With Refractory or Relapsing Churg Strauss SyndromeChurg Strauss SyndromeDrug: mepolizumabUniversity of Schleswig-HolsteinGlaxoSmithKlineCompleted18 Years80 YearsBoth10Phase 2Germany
14EUCTR2006-001791-20-DE
(EUCTR)
30/06/200802/01/2008A 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 - MEPOCHUSSA 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 LübeckNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Germany
15NCT00527566
(ClinicalTrials.gov)
September 20077/9/2007Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss SyndromeMepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss SyndromeChurg Strauss SyndromeBiological: MepolizumabBrigham and Women's HospitalGlaxoSmithKlineCompleted19 YearsN/AAll10Phase 1/Phase 2United States
16NCT00266565
(ClinicalTrials.gov)
December 200115/12/2005Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic SyndromeA Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic SyndromesHypereosinophilic Syndromes;Eosinophilic Gastroenteritis;Churg-Strauss Syndrome;Eosinophilic EsophagitisDrug: MepolizumabChildren's Hospital Medical Center, CincinnatiNULLCompleted18 Years65 YearsAll24Phase 1/Phase 2United States