44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details


臨床試験数 : 92 薬物数 : 106 - (DrugBank : 27) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 78

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05263934
(ClinicalTrials.gov)
March 14, 202228/2/2022Efficacy 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) TherapyEosinophilic Granulomatosis With PolyangiitisBiological: Depemokimab;Biological: Mepolizumab;Drug: Placebo matching mepolizumab;Drug: Placebo matching depemokimabGlaxoSmithKlineNULLNot yet recruiting18 YearsN/AAll160Phase 3NULL
2NCT05030155
(ClinicalTrials.gov)
December 202131/7/2021Study of Mepolizumab-based Regimen Compared to Conventional Therapeutic Strategy in Patients With Eosinophilic Granulomatosis With Polyangiitis (E-merge)Evaluation of MEpolizumab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind StudyEosinophilic Granulomatosis With PolyangiitisDrug: Mepolizumab;Drug: cyclophosphamide/azathioprine;Drug: PlaceboAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study Group;URC-CIC Paris Descartes Necker CochinNot yet recruiting18 YearsN/AAll100Phase 3France
3EUCTR2021-000679-35-FR
(EUCTR)
07/09/202125/06/2021SATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with PolyangiitisSATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis” - SATELITE Granulomatosis with Polyangiitis;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Rituximab
INN or Proposed INN: RITUXIMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Trade Name: ORENCIA
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Mycophénolate mofétil
Other descriptive name: MYCOPHENOLATE MOFETIL
Trade Name: Azathioprine
Other descriptive name: AZATHIOPRINE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2France
4NCT04871191
(ClinicalTrials.gov)
September 202126/2/2021Study of Salvage Therapy to Treat Patients With Granulomatosis With PolyangiitisSalvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With PolyangiitisGranulomatosis With Polyangiitis;Anti-neutrophil Cytoplasmic Antibody-associated VasculitisDrug: Rituximab;Drug: Tocilizumab;Drug: AbataceptAssistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinNot yet recruiting18 YearsN/AAll42Phase 2France
5NCT04944524
(ClinicalTrials.gov)
July 1, 202122/6/2021Comparison of Tofacitinib and Methotrexate in the Maintained Treatment of GPARandomized Trial of Tofacitinib Versus Methotrexate for Maintenance Therapy in Granulomatosis With PolyangiitisGranulomatosis With PolyangiitisDrug: Tofacitinib;Drug: MethotrexateShanghai Zhongshan HospitalNULLRecruiting18 Years75 YearsAll66Phase 4China
6NCT04316494
(ClinicalTrials.gov)
December 17, 202025/2/2020Hydroxychloroquine in ANCA Vasculitis EvaluationHydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled TrialANCA Associated Vasculitis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Wegener GranulomatosisDrug: Hydroxychloroquine;Drug: PlaceboGuy's and St Thomas' NHS Foundation TrustMedical Research CouncilRecruiting18 YearsN/AAll76Phase 4United Kingdom
7NCT04280601
(ClinicalTrials.gov)
August 1, 202018/2/2020PRagmatic Analysis of Vitamin D in ANCA-Associated VasculitisA Local Interventional Study in a Cohort of Patients With GPA, MPA and EGPA (PART 2 of Vitamin D Status in ANCA-associated Vasculitis: Analysis of RDCRN-VCRC and Local Clinic Cohorts of Patients With GPA, MPA and EGPA)ANCA-associated Vasculitis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Eosinophilic Granulomatosis With PolyangiitisDietary Supplement: vitamin DChristian PagnouxNULLActive, not recruiting18 YearsN/AAll100N/ACanada
8EUCTR2019-001832-77-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
9EUCTR2018-001268-40-GB
(EUCTR)
23/01/202013/09/2019Hydroxychloroquine in ANCA vasculitisHydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial - HAVEN The term ANCA-associated vasculitis (AAV) describes a subset of primary small vessel vasculitides characterized by the presence of anti-neutrophil cytoplasmic antibodies (ANCA): Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and Eosinophilic Granulomatosis with Polyangiitis (EGPA). AAV are serious multisystem autoimmune disorders that can affect any organ in the body and commonly involve the ear-nose-throat, lungs, kidneys, eyes and joints
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Plaquenil - Hydroxychloroquine 200mg Film coated tabletsGuy's and St. Thomas' NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
76Phase 4United Kingdom
10EUCTR2019-001832-77-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
11JPRN-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
12EUCTR2019-001832-77-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
13NCT04157348
(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
14EUCTR2019-001832-77-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
15EUCTR2018-000768-27-DK
(EUCTR)
05/08/201920/03/2019Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: not yet available
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
81Phase 2Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
16EUCTR2018-003903-21-FR
(EUCTR)
04/06/201919/02/2019A Study to Assess the pharmacokinetics and pharmacodynamics of INS1007 Administered Once Daily in Patients with Granulomatosis with Polyangiitis (GPA)A Randomized, Single-Blind Study to Evaluate the Pharmacokinetics (PK), and Pharmacodynamics (PD) of INS1007 Administered for 12 Weeks in Subjects with Granulomatosis with Polyangiitis (GPA) Granulomatosis with Polyangiitis (GPA
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: INS1007
INN or Proposed INN: Not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: Not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: Not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot Recruiting Female: yes
Male: yes
16 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
17EUCTR2018-000768-27-GB
(EUCTR)
17/04/201927/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - InflaRx GmbH_IFX-1-P2.5 Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: not yet available
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: PredniSONE Tablets, USP
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 2Spain;Ireland;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
18EUCTR2018-000768-27-BE
(EUCTR)
04/04/201901/05/2019Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: not yet available
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
19NCT03895801
(ClinicalTrials.gov)
April 3, 20198/3/2019Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)Granulomatosis With Polyangiitis (GPA);Microscopic Polyangiitis (MPA)Drug: IFX-1;Drug: Placebo-IFX-1;Drug: Glucocorticoid (GC);Drug: Placebo-Glucocorticoid (Placebo-GC)InflaRx GmbHNULLCompleted18 YearsN/AAll57Phase 2Belgium;Czechia;France;Germany;Italy;Netherlands;Russian Federation;Spain;Sweden;Switzerland;United Kingdom;Denmark
20NCT03919435
(ClinicalTrials.gov)
March 27, 20195/4/2019Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With PolyangiitisTrimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With PolyangiitisGranulomatosis With Polyangiitis;Wegener GranulomatosisDrug: Trimethoprim SulfamethoxazoleUniversity of PennsylvaniaNULLActive, not recruiting18 YearsN/AAll30Phase 1/Phase 2United States
21EUCTR2018-000768-27-DE
(EUCTR)
11/03/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
22EUCTR2018-000768-27-NL
(EUCTR)
10/03/201920/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Germany;Netherlands;United Kingdom;Italy;Sweden
23EUCTR2018-000768-27-IT
(EUCTR)
27/02/201924/05/2021Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients wit Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
Product Code: [Glucocorticoids (GC)]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
Product Code: [Glucocorticoids (GC)]
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Product Name: IFX-1
Product Code: [IFX-1]
INN or Proposed INN: not yet available
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
81Phase 2Czechia;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
24EUCTR2018-000768-27-SE
(EUCTR)
08/02/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2Spain;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Czechia;Sweden
25NCT03482479
(ClinicalTrials.gov)
February 4, 201922/3/2018Low Dose Naltrexone to Improve Physical Health in Patients With VasculitisLow Dose Naltrexone to Improve Physical Health in Patients With VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu ArteritisDrug: Naltrexone Hydrochloride;Other: Placebo ComparatorUniversity of PennsylvaniaNULLRecruiting18 YearsN/AAll36Phase 2United States
26NCT03967925
(ClinicalTrials.gov)
February 1, 201918/1/2019Rituximab and Belimumab Combination Therapy in PR3 VasculitisA Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated VasculitisANCA Associated Vasculitis;Granulomatosis With PolyangiitisDrug: Belimumab;Drug: Rituximab;Drug: PrednisoloneRachel JonesGlaxoSmithKline;Medical Research Council;Imperial College London;University College, London;Newcastle University;University of Glasgow;University of CambridgeRecruiting18 YearsN/AAll30Phase 2United Kingdom
27EUCTR2018-000768-27-ES
(EUCTR)
17/01/201918/01/2019Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: not yet available
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
Trade Name: GALEN® tablet
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Czech Republic;Belgium;Spain;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden
28EUCTR2018-000768-27-CZ
(EUCTR)
10/01/201919/12/2018Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA)
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: IFX-1
INN or Proposed INN: Vilobelimab
Other descriptive name: chimeric monoclonal antibody, IgG4 subtype
Trade Name: PredniSONE Tablets, USP
Product Name: Glucocorticoids (GC)
INN or Proposed INN: PREDNISONE
InflaRx GmbHNULLNot RecruitingFemale: yes
Male: yes
55Phase 2Sweden;Italy;United Kingdom;Germany;Netherlands;Russian Federation;Denmark;Belgium;Spain;Czech Republic;Czechia;France
29NCT03712345
(ClinicalTrials.gov)
October 15, 201816/10/2018Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)Granulomatosis With Polyangiitis (GPA);Microscopic Polyangiitis (MPA)Drug: IFX-1;Drug: PlaceboInflaRx GmbHIqvia Pty LtdCompleted18 YearsN/AAll19Phase 2United States;Canada
30JPRN-UMIN000024574
2018/07/0201/05/2017Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ Microscopic polyangiitis (MPA)Granulomatosis with polyangiitis (GPA)TCZ group
Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks.
Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks.
If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24.
Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.


IVCY group
Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times).
From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.
Tokyo women's medical universityInstitute of rheumatologyHokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University HospitalRecruiting20years-old85years-oldMale and Female48Phase 2Japan
31JPRN-JMA-IIA00325
01/07/201823/01/2018Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks.
Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks.
If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24.
Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48.
. Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen:Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times).
From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52.
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day..
Masayoshi HarigaiNULLPending>=20 YEARS<80 YEARSBOTH48Phase 2Japan
32NCT03164473
(ClinicalTrials.gov)
March 7, 201822/5/2017Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis.MAINtenance of Remission With RITuximab Versus Azathioprine for Patients With Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Prospective, Randomized, Controlled, Double-blind Study: the MAINRITSEG TrialEosinophilic Granulomatosis With PolyangiitisDrug: Rituximab;Drug: Azathioprine;Drug: Placebo-rituximab;Drug: Placebo-azathioprineAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupRecruiting18 YearsN/AAll98Phase 4France
33NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
34EUCTR2016-001121-14-NO
(EUCTR)
06/10/201707/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden
35NCT02947945
(ClinicalTrials.gov)
September 12, 201717/10/2016Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) StudyOpen-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE StudyAsthmaDrug: ReslizumabNational Jewish HealthTEVARecruiting18 YearsN/AAll10Phase 2United States
36EUCTR2016-001121-14-NL
(EUCTR)
15/06/201718/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
37EUCTR2016-001121-14-BE
(EUCTR)
08/05/201706/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
38EUCTR2016-001121-14-IT
(EUCTR)
04/05/201707/01/2021A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV).Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Trade Name: Prednison acis¿ 5 mg
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Trade Name: Prednison acis¿ 20 mg
CHEMOCENTRYX, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
39EUCTR2016-001121-14-HU
(EUCTR)
24/04/201723/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
40NCT03010436
(ClinicalTrials.gov)
April 15, 201711/12/2016Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) StudyThe Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITEAsthmaDrug: BenralizumabNational Jewish HealthAstraZenecaActive, not recruiting18 Years100 YearsAll10Phase 2United States
41EUCTR2016-001121-14-DK
(EUCTR)
07/04/201701/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
42EUCTR2016-001121-14-GB
(EUCTR)
06/04/201723/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Sweden
43EUCTR2016-001121-14-ES
(EUCTR)
21/03/201720/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSweden;New Zealand;Germany;Netherlands;Norway;Denmark;Australia;Belgium;Canada;Czech Republic;Hungary;France;United Kingdom;Switzerland;Italy;Austria;Ireland;Spain;United States
44EUCTR2016-001121-14-CZ
(EUCTR)
20/03/201712/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
45EUCTR2016-001121-14-AT
(EUCTR)
13/02/201710/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
46EUCTR2016-001121-14-SE
(EUCTR)
13/02/201721/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
47NCT02807103
(ClinicalTrials.gov)
December 5, 201620/5/2016Rituximab in Eosinophilic Granulomatosis With PolyangiitisEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind StudyEosinophilic Granulomatosis With Polyangiitis (EGPA)Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamideAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupCompleted18 YearsN/AAll107Phase 3France
48EUCTR2013-005535-24-GB
(EUCTR)
07/06/201603/12/2015Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)Abatacept (CTLA4-Ig) for the treatment of relapsing, non-severe, granulomatosis with polyangiitis (Wegener's) - ABROGATE Granulomatosis with polyangiitis (GPA; Wegener's granulomatosis)
MedDRA version: 19.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866
MedDRA version: 19.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: Abatacept
Univeristy of South FloridaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;France;Mexico;Canada;Spain;Ireland;Australia;Germany;Switzerland;Italy;United Kingdom;Sweden
49EUCTR2013-005535-24-IE
(EUCTR)
04/05/201611/02/2016Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s)
MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866
MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 100000004866
MedDRA version: 20.1;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
Product Name: Abatacept (CTLA4-Ig)
INN or Proposed INN: ABATACEPT
University of South FloridaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 3United States;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Belgium;Australia;Germany;Sweden
50EUCTR2016-000275-25-FR
(EUCTR)
21/03/201613/04/2016Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVASEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening
MedDRA version: 19.0;Level: PT;Classification code 10048594;Term: Allergic granulomatous angiitis;System Organ Class: 10021428 - Immune system disorders
Trade Name: RITUXIMAB
Product Name: RITUXIMAB
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: CYCLOPHOSPHAMIDE
Product Name: CYCLOPHOSPHAMIDE
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: MESNA
Product Name: MESNA
INN or Proposed INN: mesna
Other descriptive name: MESNA
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
108Phase 3France
51NCT02626845
(ClinicalTrials.gov)
December 20158/12/2015Rituximab for the Otolaryngologic Manifestations of Granulomatosis With PolyangiitisRituximab for the Otolaryngologic Manifestations of Granulomatosis With PolyangiitisGranulomatosis With Polyangiitis (Wegener's Granulomatosis)Drug: Rituximab;Other: PlaceboHospital for Special Surgery, New YorkGenentech, Inc.;Roche Pharma AGTerminated18 YearsN/AAll3Phase 4United States
52EUCTR2014-003162-25-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
53EUCTR2015-001807-29-FR
(EUCTR)
09/06/201523/07/2015Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitisPharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study - MONITUX Granulomatosis with polyangiitis Microscopic polyangiitis
MedDRA version: 18.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Rituximab
Product Name: Rituximab
CHU de Saint-EtienneNULLNot RecruitingFemale: yes
Male: yes
50Phase 4France
54NCT03298061
(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
55NCT02108860
(ClinicalTrials.gov)
April 201527/3/2014Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)Granulomatosis With Polyangiitis (Wegener's);Granulomatosis With Polyangiitis;Wegener's Granulomatosis;ANCA-Associated VasculitisDrug: Abatacept;Drug: placeboUniversity of South FloridaThe Cleveland Clinic;Bristol-Myers Squibb;University of Pennsylvania;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting15 YearsN/AAll66Phase 3United States;Canada;Germany;Ireland;United Kingdom
56EUCTR2014-003162-25-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
57EUCTR2014-003162-25-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
58NCT01598857
(ClinicalTrials.gov)
December 201411/5/2012BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisA Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Blisibimod;Drug: PlaceboAnthera PharmaceuticalsNULLWithdrawn18 YearsN/ABoth0Phase 2NULL
59NCT02198248
(ClinicalTrials.gov)
October 201418/7/2014Low-dose Glucocorticoid Vasculitis Induction StudyLow-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control TrialAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisDrug: Rituximab;Drug: GlucocorticoidsChiba UniversityNULLActive, not recruiting20 YearsN/AAll140Phase 4Japan
60JPRN-UMIN000012409
2014/06/2604/12/2013An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitisAn international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM Granulomatosis With Polyangiitis (Wegener's) Microscopic PolyangiitisExperimental: Rituximab Maintenance.
Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper.

Active Comparator: Azathioprine Maintenance.
Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation). Azathioprine withdrawn at month 27.
University of Miyazaki HospitalThe European Vasculitis SocietyVasculitis Clinical Research ConsortiumComplete: follow-up complete18years-oldNot applicableMale and Female190Phase 3Japan,North America,South America,Australia,Europe
61NCT02169219
(ClinicalTrials.gov)
June 201419/6/2014Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated VasculitisShort-Course Glucocorticoids and Rituximab in ANCA-Associated VasculitisGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: Glucocorticoids;Drug: RituximabMassachusetts General HospitalGenentech, Inc.Completed18 Years85 YearsAll20Phase 4United States
62NCT01933724
(ClinicalTrials.gov)
February 17, 201428/8/2013The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric ApproachThe Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric ApproachGranulomatosis With Polyangiitis;Wegener Granulomatosis;VasculitisDrug: 5 mg prednisone;Drug: 0 mg prednisoneUniversity of South FloridaNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS);Rare Diseases Clinical Research NetworkActive, not recruiting18 YearsN/AAll12Phase 3United States
63NCT02020889
(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
64NCT01940094
(ClinicalTrials.gov)
February 20146/9/2013The Assessment of Prednisone In Remission Trial - Centers of Excellence ApproachThe Assessment of Prednisone In Remission Trial (TAPIR) - Centers of Excellence ApproachGranulomatosis With PolyangiitisDrug: 5 mg Prednisone;Drug: 0 mg PrednisoneUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS);Rare Diseases Clinical Research NetworkRecruiting18 YearsN/AAll159Phase 3United States;Canada
65EUCTR2012-004385-17-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
66EUCTR2012-004385-17-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
67EUCTR2012-004385-17-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
68EUCTR2012-004385-17-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
69EUCTR2012-004385-17-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
70NCT01750697
(ClinicalTrials.gov)
May 23, 201313/12/2012A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisA Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisGranulomatosis With PolyangiitisDrug: RituximabHoffmann-La RocheNULLCompleted2 Years17 YearsAll25Phase 2United States;Canada;France;Germany;Italy;Serbia;Turkey;United Kingdom
71NCT01697267
(ClinicalTrials.gov)
April 201331/8/2012Rituximab Vasculitis Maintenance StudyAn International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener GranulomatosisBiological: Rituximab;Drug: AzathioprineCambridge University Hospitals NHS Foundation TrustArthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of PennsylvaniaCompleted15 YearsN/AAll188Phase 3United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic
72EUCTR2012-002062-13-DE
(EUCTR)
14/03/201313/09/2012A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitisA Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis
MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: MabThera®
Product Code: RO0452294/V01
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
73EUCTR2012-002062-13-IT
(EUCTR)
28/01/201311/01/2013A PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITISA PHASE IIA, INTERNATIONAL, MULTICENTER, OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF 4 x 375 mg/m2 INTRAVENOUS RITUXIMAB IN PEDIATRIC PATIENTS WITH SEVERE GRANULOMATOSIS WITH POLYANGIITIS (WEGENER’S) OR MICROSCOPIC POLYANGIITIS granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
MedDRA version: 14.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
INN or Proposed INN: RITUXIMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Turkey;United Kingdom;Italy
74EUCTR2012-002062-13-GB
(EUCTR)
18/01/201323/08/2012A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitisA Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis
MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: MabThera®
Product Code: RO0452294/V01
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera®
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom
75NCT01731561
(ClinicalTrials.gov)
November 16, 201212/10/2012Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis IIGranulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited FormsDrug: Rituximab (Arm B);Drug: Rituximab (Arm A)Assistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll166Phase 3France
76NCT01613599
(ClinicalTrials.gov)
June 20, 20124/6/2012An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisProspective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With RituximabGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: RituximabGenentech, Inc.NULLCompleted18 YearsN/AAll100United States
77EUCTR2011-001219-30-DE
(EUCTR)
17/01/201220/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma SASNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
78EUCTR2011-001219-30-GB
(EUCTR)
08/11/201112/07/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma SASNULLNot Recruiting Female: yes
Male: yes
216 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
79NCT01446211
(ClinicalTrials.gov)
November 201120/9/2011Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus Versus Conventional Therapy in Relapse of Granulomatosis With Polyangiitis (Wegener's Granulomatosis) SPARROW Study - SPAnidin in Relapsing GRanulomatosis With POlyangiitis Wegener's Granulomatosis)Wegeners GranulomatosisDrug: Gusperimus + glucocorticoids;Drug: cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoidsNordic Pharma SASNULLTerminated18 Years75 YearsBoth4Phase 3Czech Republic
80EUCTR2011-001219-30-ES
(EUCTR)
14/10/201104/07/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener?s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener?s Granulomatosis) - SPARROW study ? SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener?s granulomatosis) Relapse of Wegener?s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma FranceNULLNot RecruitingFemale: yes
Male: yes
216United Kingdom;Slovakia;Russian Federation;Germany;Czech Republic;Netherlands;France;Spain;Italy;United States;Sweden
81EUCTR2011-001219-30-SK
(EUCTR)
28/09/201105/10/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma SASNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
82EUCTR2011-001219-30-SE
(EUCTR)
31/08/201121/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma FranceNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
83EUCTR2011-001219-30-CZ
(EUCTR)
18/08/201120/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma FranceNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
84NCT01405807
(ClinicalTrials.gov)
February 201127/7/2011Alemtuzumab for ANCA Associated Refractory VasculitisAlemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and EfficacyVasculitis;Microscopic Polyangiitis;Granulomatosis With Polyangiitis;Wegener'sDrug: AlemtuzumabCambridge University Hospitals NHS Foundation TrustNULLRecruiting18 Years60 YearsBoth24Phase 4United Kingdom
85NCT03919825
(ClinicalTrials.gov)
May 201015/4/2019Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - GlucocorticoidsPlasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial [Glucocorticoids]Granulomatosis With Polyangiitis (Wegener's) (GPA);Microscopic Polyangiitis (MPA)Drug: Glucocorticoids - Standard Dose;Drug: Glucocorticoids - Reduced DoseUniversity of PennsylvaniaNULLCompleted15 YearsN/AAll704Phase 3NULL
86NCT00987389
(ClinicalTrials.gov)
May 201023/9/2009Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated VasculitisPlasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled TrialGranulomatosis With Polyangiitis (Wegener's) (GPA);Microscopic Polyangiitis (MPA)Procedure: Plasma Exchange;Other: No Plasma Exchange;Drug: Glucocorticoids [Standard Dose];Drug: Glucocorticoids [Reduced Dose]University of PennsylvaniaCambridge University Hospitals NHS Foundation Trust;University of Birmingham;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed15 YearsN/AAll704Phase 3United States;Australia;Belgium;Canada;Czechia;Denmark;France;Greece;Italy;Japan;Mexico;New Zealand;Norway;Sweden;United Kingdom;Czech Republic
87NCT00748644
(ClinicalTrials.gov)
October 20085/9/2008Efficacy Study of Two Treatments in the Remission of VasculitisMAINtenance of Remission Using RITuximab in Systemic ANCA-associated VasculitisWegener Granulomatosis;Microscopic PolyangiitisDrug: Rituximab;Drug: AzathioprineAssistance Publique - Hôpitaux de ParisNULLCompleted18 Years75 YearsAll117Phase 3France
88NCT00647166
(ClinicalTrials.gov)
May 200826/3/2008Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis FactorsMPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of CorticosteroidsDrug: corticosteroid and azathioprine;Drug: corticosteroid and placeboAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/ABoth114Phase 3France
89EUCTR2016-001121-14-FR
(EUCTR)
22/06/2018A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
90EUCTR2016-001121-14-IE
(EUCTR)
21/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
91EUCTR2013-005535-24-DE
(EUCTR)
18/08/2017Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s)
MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000140455
MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
Product Name: Abatacept (CTLA4-Ig)
University of South FloridaNULLNAFemale: yes
Male: yes
150Phase 3United States;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;Australia;Germany;Sweden
92EUCTR2016-001121-14-DE
(EUCTR)
23/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden