DDrare: Database of Drug Development for Rare Diseases

Searched query = "Microscopic polyangiitis", "MPA"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 5009111000001105; Alemtuzumab; Avacopan; Azathioprine; BELIMUMAB; Belimumab; Belimumab 10 mg/kg; Benlysta; Benlysta 400 mg powder for concentrate for solution for infusion; Benlysta 400mg polvere per concentrato per soluzione per infusione; Blisibimod; CCX168; CELLCEPT; CYCLOPHOSPHAMIDE; CellCept (mycophenolate mofetil); Cellcept; Chimeric monoclonal antibody, IgG4 subtype; Corticosteroid; Corticosteroid and azathioprine; Cyclophosphamide; Cyclophosphamide, Azathioprine,prednisone,methylprednisolone; DELTACORTENE; ENDOXAN BAXTER; Endoxan; Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS); GALEN® tablet; Glucocorticoid (GC); Glucocorticoids; Glucocorticoids (GC); Glucocorticoids - Reduced Dose; Glucocorticoids - Standard Dose; Glucocorticoids [Reduced Dose]; Glucocorticoids [Standard Dose]; Human normal immunoglobulin; Hydroxychloroquine; IFX-1; Infliximab; Intravenous immunoglobulins (human immunoglobulins G); Intravenous methyl prednisolone; MabThera; MabThera®; MabThera® 100MG; MabThera® 500MG; Methotrexate; Methyl prednisolone; Methylprednisolone; Methylprednisolone (or other glucocorticoid); Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolate mofetil,methotrexate; Mycophenolic acid; Naltrexone; Naltrexone Hydrochloride; Other: No Plasma Exchange; PREDNISONE; Pednisone; Placebo (physiological saline); Plaquenil - Hydroxychloroquine 200mg Film coated tablets; PredniSONE Tablets, USP; Prednisolone; Prednison acis® 20 mg; Prednison acis® 5 mg; Prednisone; Prednisone (and methylprednisolone); Prednisone, methylprednisolone,cyclophosphamides; Procedure: Plasma Exchange; Procedure: Plasma exchange; RITUXIMAB; RIXATHON 500mg; RO0452294/V01; RO0452294/V02; Remission induction therapy; Rituximab; Rituximab (Arm A); Rituximab (Arm B); Ro106-1443; Sendoxan; Tocilizumab; Vitamin D

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-000768-27-DK (EUCTR)	05/08/2019	20/03/2019	Efficacy 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 GmbH	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	81	Phase 2	Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
2	EUCTR2018-000768-27-DE (EUCTR)	11/03/2019	19/12/2018	Efficacy 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 GmbH	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	81	Phase 2	Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
3	EUCTR2018-000768-27-SE (EUCTR)	08/02/2019	19/12/2018	Efficacy 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 GmbH	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	81	Phase 2	Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
4	EUCTR2018-000768-27-CZ (EUCTR)	10/01/2019	19/12/2018	Efficacy 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 GmbH	NULL	Not Recruiting	Female: yes Male: yes	81	Phase 2	France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-000768-27-DK
(EUCTR)

05/08/2019

20/03/2019

Efficacy 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 GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden

EUCTR2018-000768-27-DE
(EUCTR)

11/03/2019

19/12/2018

Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.

InflaRx GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden

EUCTR2018-000768-27-SE
(EUCTR)

08/02/2019

19/12/2018

Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.

InflaRx GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden

EUCTR2018-000768-27-CZ
(EUCTR)

10/01/2019

19/12/2018

Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.

InflaRx GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden