DDrare: Database of Drug Development for Rare Diseases

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

Drug = 0 mg Prednisone; 0 mg prednisone; 5 mg Prednisone; 5 mg prednisone; ABATACEPT; AZD7986; Abatacept; Abatacept (CTLA4-Ig); Alemtuzumab; Avacopan; Azathioprin-ratiopharm® 25 mg Filmtabletten; Azathioprine; Azathioprine 25 mg; Belimumab; Benralizumab; Biological: Benralizumab, Biological: Placebo to Mepolizumab; Biological: Mepolizumab, Biological: Placebo to Benralizumab; Blisibimod; CCX168; CYCLOPHOSPHAMIDE; Chimeric monoclonal antibody, IgG4 subtype; Corticosteroid; Corticosteroid and azathioprine; Cyclophosphamide; Cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids; Cyclophosphamidum; Cyclophosphamidum 500 mg; Endoxan; Endoxan® 500 mg; GALEN® tablet; Glucocorticoid (GC); Glucocorticoids; Glucocorticoids (GC); Glucocorticoids - Reduced Dose; Glucocorticoids - Standard Dose; Glucocorticoids [Reduced Dose]; Glucocorticoids [Standard Dose]; Gusperimus; Gusperimus + glucocorticoids; Hydroxychloroquine; IFX-1; INS1007; L04AC06; MEDI-563; MEPOLIZUMAB; MESNA; METOJECT 10 mg/ml, solution injectable en seringue pré-remplie; MabThera; MabThera®; Mepolizumab; Mesna; Metex 2,5 mg Tabletten; Methotrexate; Methotrexate 2.5 mg; Methotrexate 25 mg; NUCALA; Naltrexone; Naltrexone Hydrochloride; Nucala; Nucala 100 mg powder for solution for injection; Orencia; Other: No Plasma Exchange; PREDNISONE; Pednisone; Plaquenil - Hydroxychloroquine 200mg Film coated tablets; PredniSONE Tablets, USP; Prednisolone; Prednison acis® 20 mg; Prednison acis® 5 mg; Prednisone; Procedure: Plasma Exchange; RITUXIMAB; RO0452294/V01; RO0452294/V02; Recombinant humanized monoclonal antibody specific for human IL-5; Remission induction therapy; Reslizumab; Rituximab; Rituximab (Arm A); Rituximab (Arm B); SB-240563; SB-240563 (mepolizumab); Sulfamethoxazole; Trimethoprim; Trimethoprim Sulfamethoxazole; Vitamin D; Yellow Fever Vaccine; Yellow Fever vaccine (17D)

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
1	EUCTR2019-001832-77-DE (EUCTR)	15/01/2020	21/08/2019	Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab.	A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy	Eosinophilic Granulomatosis with Polyangiitis (EGPA) MedDRA version: 20.1;Level: LLT;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: Benralizumab Trade Name: Nucala 100 mg powder for solution for injection Product Name: mepolizumab Product Code: L04AC06 INN or Proposed INN: Mepolizumab Other descriptive name: Nucala	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;France;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy
2	JPRN-JapicCTI-195049	24/12/2019	26/11/2019	MANDARA	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 Granulomatous Vasculitis	Intervention 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 KK	NULL	recruiting	18		BOTH	6	Phase 3	Japan, North America, Europe
3	EUCTR2019-001832-77-FR (EUCTR)	23/12/2019	02/08/2019	A 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 AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom
4	NCT04157348 (ClinicalTrials.gov)	October 29, 2019	29/9/2019	Efficacy 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 Granulomatous Vasculitis	Biological: Benralizumab;Biological: Mepolizumab;Biological: Placebo to Mepolizumab;Biological: Placebo to Benralizumab	AstraZeneca	NULL	Recruiting	18 Years	130 Years	All	140	Phase 3	United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom
5	EUCTR2019-001832-77-GB (EUCTR)	20/08/2019	22/10/2020	Efficacy 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 AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT03010436 (ClinicalTrials.gov)	April 15, 2017	11/12/2016	Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study	The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE	Asthma	Drug: Benralizumab	National Jewish Health	AstraZeneca	Recruiting	18 Years	100 Years	All	10	Phase 2	United States

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

EUCTR2019-001832-77-DE
(EUCTR)

15/01/2020

21/08/2019

Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab.

A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab compared to Mepolizumab in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in patients receiving Standard of Care Therapy

Eosinophilic Granulomatosis with Polyangiitis (EGPA)
MedDRA version: 20.1;Level: LLT;Classification code 10014957;Term: Eosinophilic granulomatous vasculitis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: Benralizumab
Trade Name: Nucala 100 mg powder for solution for injection
Product Name: mepolizumab
Product Code: L04AC06
INN or Proposed INN: Mepolizumab
Other descriptive name: Nucala

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;France;Canada;Belgium;Israel;Germany;United Kingdom;Japan;Italy

JPRN-JapicCTI-195049

24/12/2019

26/11/2019

MANDARA

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 Granulomatous Vasculitis

Intervention 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 KK

NULL

recruiting

BOTH

Phase 3

Japan, North America, Europe

EUCTR2019-001832-77-FR
(EUCTR)

23/12/2019

02/08/2019

A study to evaluate if benralizumab compared to mepolizumab may be beneficial in the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).

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 AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom

NCT04157348
(ClinicalTrials.gov)

October 29, 2019

29/9/2019

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

Eosinophilic Granulomatous Vasculitis

Biological: Benralizumab;Biological: Mepolizumab;Biological: Placebo to Mepolizumab;Biological: Placebo to Benralizumab

AstraZeneca

NULL

Recruiting

18 Years

130 Years

All

140

Phase 3

United States;Belgium;Canada;France;Germany;Israel;Italy;Japan;United Kingdom

EUCTR2019-001832-77-GB
(EUCTR)

20/08/2019

22/10/2020

Efficacy and Safety of Benralizumab in EGPA compared to mepolizumab.

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 AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;France;Canada;Belgium;Israel;Germany;Japan;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03010436
(ClinicalTrials.gov)

April 15, 2017

11/12/2016

Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE

Asthma

Drug: Benralizumab

National Jewish Health

AstraZeneca

Recruiting

18 Years

100 Years

All

Phase 2

United States