Uplizna ( DrugBank: - )
2 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 11 | 重症筋無力症 | 2 |
| 300 | IgG4関連疾患 | 4 |
11. 重症筋無力症
臨床試験数 : 315 / 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
| 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 | EUCTR2020-000949-14-DE (EUCTR) | 30/07/2021 | 08/12/2020 | Inebilizumab efficacy and safety in adults with myasthenia gravis | A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) | Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Uplizna Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 2 | EUCTR2020-000949-14-DK (EUCTR) | 24/02/2021 | 24/11/2020 | Inebilizumab efficacy and safety in adults with myasthenia gravis | A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,PLACEBO-CONTROLLED PHASE 3 STUDY WITHOPEN-LABEL PERIOD TO EVALUATE THE EFFICACYAND SAFETY OF INEBILIZUMAB IN ADULTS WITHMYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) | Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Uplizna Product Name: Inebilizumab INN or Proposed INN: INEBILIZUMAB Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of |
300. IgG4関連疾患
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 |