300. IgG4関連疾患 IgG4-related disease Clinical trials / Disease details
臨床試験数 : 36 / 薬物数 : 49 - (DrugBank : 22) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 98
| 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 | JPRN-jRCT2071210001 | 18/08/2021 | 01/04/2021 | A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease | A Phase 3, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease - VIB0551.P3.S2 | IgG4-Related Disease | RCP: 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 Sota | NULL | Recruiting | >= 20age old | Not applicable | Both | 16 | Phase 3 | USA;China;Australia;Canada;France;Italy;Germay;Hong Kong;Hungary;Israel;Ireland;Mexico;Netherlands;Poland;Argentina;Spain;UK;Turkey;Ukraine;Sweden;India;Japan |
| 2 | EUCTR2020-000417-33-SE (EUCTR) | 30/03/2021 | 19/11/2020 | Inebilizumab efficacy and safety in IgG4 related disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Sweden;Japan;China;Germany;Netherlands;Australia;Poland;Argentina;Canada;Mexico;Hungary;France;India;Italy;United Kingdom;Israel;Turkey;Ireland;Ukraine;Spain;Hong Kong;United States | ||
| 3 | EUCTR2020-000417-33-NL (EUCTR) | 26/02/2021 | 29/09/2020 | Inebilizumab efficacy and safety in IgG4 related disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Germany;Netherlands;China;Japan;Sweden | ||
| 4 | EUCTR2020-000417-33-IT (EUCTR) | 16/12/2020 | 21/10/2020 | Inebilizumab efficacy and safety in IgG4 related disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 5 | NCT04540497 (ClinicalTrials.gov) | October 26, 2020 | 1/9/2020 | A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease | A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease | IgG4 Related Disease | Drug: Inebilizumab;Other: Placebo | Viela Bio | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | United States;Argentina;Australia;Canada;China;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;Ukraine;United Kingdom |
| 6 | EUCTR2020-000417-33-HU (EUCTR) | 06/10/2020 | 06/08/2020 | Inebilizumab efficacy and safety in IgG4 related disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Ukraine;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Australia;Germany;Netherlands;China;Japan;Korea, Republic of | ||
| 7 | EUCTR2020-000417-33-DE (EUCTR) | 30/09/2020 | 24/06/2020 | A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease - MITIGATE | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Netherlands;Germany;Japan;China;Sweden | ||
| 8 | EUCTR2020-000417-33-PL (EUCTR) | 02/09/2020 | 30/06/2020 | Inebilizumab efficacy and safety in IgG4 related disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Hong Kong;Spain;Ukraine;Ireland;Turkey;Israel;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;Netherlands;Germany;Japan;China;Sweden |