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A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
Sponsor: Amgen
Summary
This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).
Official title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
135
Start Date
2020-12-04
Completion Date
2028-10-31
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Inebilizumab
Inebilizumab is a monoclonal antibody that depletes B cells.
Placebo
Placebo
Locations (72)
Viela Bio Investigative Site
Palo Alto, California, United States
Viela Bio Investigative Site
Atlanta, Georgia, United States
Viela Bio Investigative Site
Baltimore, Maryland, United States
Viela Bio Investigative Site
Boston, Massachusetts, United States
Viela Bio Investigative Site
Buenos Aires, Argentina
Viela Bio Investigative Site
Mendoza, Argentina
Viela Bio Investigative Site
Auchenflower, Queensland, Australia
Viela Bio Investigative Site
Adelaide, South Australia, Australia
Viela Bio Investigative Site
Fitzroy, Australia
Viela Bio Investigative Site
Sherbrooke, Canada
Viela Bio Investigative Site 1
Toronto, Canada
Viela Bio Investigative Site 2
Toronto, Canada
Viela Bio Investigative Site
Hohhot, Inner Mongolia, China
Viela Bio Investigative Site 1
Beijing, China
Viela Bio Investigative Site 2
Beijing, China
Viela Bio Investigative Site 3
Beijing, China
Viela Bio Investigative Site 4
Beijing, China
Viela Bio Investigative Site 5
Beijing, China
Viela Bio Investigative Site
Guandong, China
Viela Bio Investigative Site
Shang’ai, China
Viela Bio Investigative Site
Shenyang, China
Viela Bio Investigative Site
Wuhan, China
Viela Bio Investigative Site
Clichy, France
Viela Bio Investigative Site
Lille, France
Viela Bio Investigative Site
Marseille, France
Viela Bio Investigative Site
Nantes, France
Viela Bio Investigative Site
Pessac, France
Viela Bio Investigative Site
Berlin, Germany
Viela Bio Investigative Site
Lübeck, Germany
Viela Bio Investigative Site
München, Germany
Viela Bio Investigative Site
Hong Kong, Hong Kong
Viela Bio Investigative Site
Debrecen, Hungary
Viela Bio Investigative Site
Szeged, Hungary
Viela Bio Investigative Site
Bangalore, India
Viela Bio Investigative Site
Cork, Ireland
Viela Bio Investigative Site
Kfar Saba, Israel
Viela Bio Investigative Site
Petah Tikva, Israel
Viela Bio Investigative Site
Tel Aviv, Israel
Viela Bio Investigative Site
Tel Litwinsky, Israel
Viela Bio Investigative Site
Florence, Italy
Viela Bio Investigative Site
Milan, Italy
Viela Bio Investigative Site
Pisa, Italy
Viela Bio Investigative Site
Reggio Emilia, Italy
Viela Bio Investigative Site
Torino, Italy
Viela Bio Investigative Site
Verona, Italy
Viela Bio Investigative Site
Fukuoka, Japan
Viela Bio Investigative Site
Hokkaido, Japan
Viela Bio Investigative Site
Hyōgo, Japan
Viela Bio Investigative Site
Ishikawa, Japan
Viela Bio Investigative Site
Kyoto, Japan
Viela Bio Investigative Site
Niigata, Japan
Viela Bio Investigative Site 2
Osaka, Japan
Viela Bio Investigative Site
Osaka, Japan
Viela Bio Investigative Site
Tokyo, Japan
Viela Bio Investigative Site
Toyama, Japan
Viela Bio Investigative Siite
Tlalpan, Mexico
Viela Bio Investigative Site
Amsterdam, Netherlands
Viela Bio Investigative Site
Rotterdam, Netherlands
Viela Bio Investigative Site
Warsaw, Poland
Viela Bio Investigative Site
Wroclaw, Poland
Viela Bio Investigative Site 2
Barcelona, Spain
Viela Bio Investigative Site
Barcelona, Spain
Viela Bio Investigative Site
Madrid, Spain
Viela Bio Investigative Site
Valencia, Spain
Viela Bio Investigative Site
Gothenburg, Sweden
Viela Bio Investigative Site
Stockholm, Sweden
Viela Bio Investigative Site
Ankara, Turkey (Türkiye)
Viela Bio Investigative Site
Istanbul, Turkey (Türkiye)
Viela Bio Investigative Site
Leeds, United Kingdom
Viela Bio Investigative Site
London, United Kingdom
Viela Bio Investigative Site
Newcastle, United Kingdom
Viela Bio Investigative Site
Oxford, United Kingdom