Uplizna ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
11Myasthenia gravis2
300IgG4-related disease4

11. Myasthenia gravis


Clinical trials : 332 Drugs : 234 - (DrugBank : 81) / Drug target genes : 45 - Drug target pathways : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000949-14-DE
(EUCTR)
30/07/202108/12/2020Inebilizumab efficacy and safety in adults with myasthenia gravisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United States;Belarus;Taiwan;Spain;Ukraine;Turkey;Israel;Russian Federation;Italy;India;France;Canada;Argentina;Poland;Brazil;Denmark;Germany;China;Japan;Korea, Republic of
2EUCTR2020-000949-14-DK
(EUCTR)
24/02/202124/11/2020Inebilizumab efficacy and safety in adults with myasthenia gravisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United 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-related disease


Clinical trials : 40 Drugs : 47 - (DrugBank : 21) / Drug target genes : 18 - Drug target pathways : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000417-33-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
2EUCTR2020-000417-33-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
3EUCTR2020-000417-33-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
4EUCTR2020-000417-33-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