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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
Sponsor: Hoffmann-La Roche
Summary
The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).
Official title: A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2023-10-26
Completion Date
2026-07-01
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
Satralizumab
Satralizumab will be administered by SC injection.
Placebo
Placebo will be administered by SC injection
Locations (46)
Thrive Health Research LLC
Beverly Hills, California, United States
UCSD Shiley Eye Center
La Jolla, California, United States
Grene Vision Group, LLC
Wichita, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, United States
Great Lakes Eye Care
Saint Joseph, Michigan, United States
'Northwell Health Physician Partners Ophthalmology
Great Neck, New York, United States
EyeHealth Northwest
Portland, Oregon, United States
Austin Retina Associates
Austin, Texas, United States
Eyelid Center of Utah
Salt Lake City, Utah, United States
WVU Eye Institute
Morgantown, West Virginia, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
Centro Oftalmologico Dr. Charles S.A.
Capital Federal, Argentina
Oftalmos
Capital Federal, Argentina
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, Argentina
Centrovision Mendoza
Mendoza, Argentina
Grupo Laser Vision
Rosario, Argentina
Sydney Eye Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Medizinische Universitat Wien
Vienna, Austria
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, Germany
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, Germany
Universitatsklinikum Munster
Münster, Germany
Universitäts-Augenklinik Tübingen
Tübingen, Germany
Hong Kong Eye Hospital
Mong Kok, Hong Kong
Budapest Retina Associates Kft.
Budapest, Hungary
A.O. U. Federico II
Naples, Campania, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Aichi Medical University Hospital
Aichi, Japan
Kyushu University Hospital
Fukuoka, Japan
Social Medical Corporation Tenjinkai Shinkoga Hospital
Fukuoka, Japan
Hokkaido University Hospital
Hokkaido, Japan
Kobe Kaisei Hospital Medical foundation
Hyōgo, Japan
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Olympia Eye Hospital
Tokyo, Japan
National University Hospital
Singapore, Singapore
Singapore Eye Research Institute
Singapore, Singapore