CD19-directed humanised afucosylated monoclonal antibody ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
11Myasthenia gravis3

11. Myasthenia gravis


Clinical trials : 315 Drugs : 232 - (DrugBank : 77) / Drug target genes : 46 - Drug target pathways : 126
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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
3EUCTR2020-000949-14-FR
(EUCTR)
16/11/202008/10/2020Inebilizumab 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]
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
252Phase 3Ukraine;United States;Belarus;Finland;Spain;Guatemala;Turkey;Russian Federation;Israel;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Japan;China