MITIGATE
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease
IRAS ID
288140
Contact name
Emma Culver
Contact email
Sponsor organisation
Viela Bio, Inc.
Eudract number
2020-000417-33
Duration of Study in the UK
3 years, 2 months, 26 days
Research summary
Immunoglobulin G4-related disease (IgG4-RD) is a fibro-inflammatory condition that can affect every organ system.
Inebilizumab is being developed as a treatment for Immunoglobulin G4-related disease. Inebilizumab binds to a protein on B-cells, a type of immune cell thought to be part of the cause of IgG4-RD. Binding of Inebilizumab to B-cells causes other parts of the immune system to target them and decrease their numbers. In this clinical trial, participants will be given Inebilizumab or placebo.
Inebilizumab is an investigational new drug. This means it has not yet been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) or any other health or regulatory authority. However, it can be used in this type of research study (known as a clinical trial).
Viela Bio is the Sponsor of this clinical trial and is responsible for the development and oversight of the study. Around 200 participants will take part in this study at medical centres in the United Kingdom, the European Union, the United States, and elsewhere.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0286
Date of REC Opinion
29 Jan 2021
REC opinion
Further Information Favourable Opinion