300. IgG4関連疾患 IgG4-related disease Clinical trials / Disease details


臨床試験数 : 40 薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141

  
8 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1JPRN-jRCT2071210001
18/08/202101/04/2021A Study of Inebilizumab Efficacy and Safety in IgG4- Related DiseaseA Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease - VIB0551.P3.S2 IgG4-Related DiseaseRCP: Blinded treatment on Day 1, Day 15, and Week 26:
- Inebilizumab group: Inebilizumab 300 mg intravenous (IV)
- Placebo group: IV placebo
Both groups: Oral prednisone (or equivalent) tablets from Day 1 to the end of Week 8
(tapering dose regimen: 2 weeks each at 20, 15, 10, and 5 mg/day of prednisone or equivalent, open-label, from commercial supply).

Optional OLP: Open-label inebilizumab 300 mg IV on Day 1 and Week 26; blinded
inebilizumab 300 mg or matching placebo on Day 15, depending on RCP treatment.
Katayama SotaNULLRecruiting>= 20age oldNot applicableBoth16Phase 3USA;China;Australia;Canada;France;Italy;Germay;Hong Kong;Hungary;Israel;Ireland;Mexico;Netherlands;Poland;Argentina;Spain;UK;Turkey;Ukraine;Sweden;India;Japan
2EUCTR2020-000417-33-SE
(EUCTR)
30/03/202119/11/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Netherlands;Germany;China;Japan;Sweden
3EUCTR2020-000417-33-NL
(EUCTR)
26/02/202129/09/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Germany;Netherlands;China;Japan;Sweden
4EUCTR2020-000417-33-IT
(EUCTR)
16/12/202021/10/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease(short title: MITIGATE – InebilizuMab effIcacy and safeTy in IGg4 relATed disEase) - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Inebilizumab
Product Code: [Inebilizumab]
INN or Proposed INN: Inebilizumab
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Trade Name: PREDNISONE DOC GENERICI - 5 MG COMPRESSE 30 COMPRESSE IN BLISTER PVC-PVDC/ALU
Product Name: Prednisone
Product Code: [Prednisone]
INN or Proposed INN: PREDNISONE
Trade Name: CETIRIZINA SANDOZ - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE IN BLISTER PVC/ALU
Product Name: Cetirizina
Product Code: [Cetirizina]
INN or Proposed INN: CETIRIZINA
Trade Name: PARACETAMOLO NOVA ARGENTIA - 500 MG COMPRESSE 20 COMPRESSE
Product Name: Paracetamolo
Product Code: [Paracetamolo]
INN or Proposed INN: PARACETAMOLO
Trade Name: METILPREDNISOLONE HIKMA - 1000 MG POLVERE PER SOLUZIONE INIETTABILE 10 FLACONCINI IN VETRO
Product Name: Metilprednisolone
Product Code: [Metilprednisolone]
INN or Proposed INN: METILPREDNISOLONE
VIELABIO Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of
5NCT04540497
(ClinicalTrials.gov)
October 26, 20201/9/2020A Study of Inebilizumab Efficacy and Safety in IgG4- Related DiseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related DiseaseIgG4 Related DiseaseDrug: Inebilizumab;Other: PlaceboViela Bio (acquired by Horizon Therapeutics)NULLRecruiting18 YearsN/AAll160Phase 3United States;Argentina;Australia;Canada;China;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;Ukraine;United Kingdom
6EUCTR2020-000417-33-HU
(EUCTR)
06/10/202006/08/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Korea, Republic of
7EUCTR2020-000417-33-DE
(EUCTR)
30/09/202024/06/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Netherlands;Germany;China;Japan;Sweden
8EUCTR2020-000417-33-PL
(EUCTR)
02/09/202030/06/2020Inebilizumab efficacy and safety in IgG4 related diseaseA Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE Immunoglobulin G4-related disease (IgG4-RD)
MedDRA version: 20.0;Level: PT;Classification code 10077271;Term: Immunoglobulin G4 related disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Uplizna
Product Name: Inebilizumab
INN or Proposed INN: INEBILIZUMAB
Other descriptive name: afucosylated IgG1 kappa monoclonal antibody
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Netherlands;Germany;Japan;China;Sweden