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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |