313
Participants
Start Date
September 16, 2021
Primary Completion Date
January 5, 2026
Study Completion Date
January 5, 2026
Teprotumumab
"Teprotumumab is a fully human anti-IGF-1R mAb. Teprotumumab will be provided in single-dose 20-mL glass vials as a freeze-dried powder containing, in addition to the drug substance, 20 mmol/L histidine-histidine chloride, 250 mmol/L trehalose and 0.01% polysorbate 20 (w/w).~Prior to administration, each vial containing 500 mg teprotumumab freeze-dried powder will be reconstituted with 10 mL of sterile water for injection. The resulting solution will have a concentration of 47.6 mg/mL teprotumumab-trbw antibody. The reconstituted teprotumumab solution must be further diluted in 0.9% (w/v) sodium chloride (NaCl) solution prior to administration"
Placebo
Placebo will consist of a normal saline (0.9% NaCl) solution and will be administered in 100 mL or 250 mL infusion bags, as appropriate, per weight-based dosing volumes.
Hospital La Arruzafa, Córdoba
ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi, Varese
Hopital Jean Minjoz, Besançon
Hospital Universitario Ramon y Cajal, Madrid
University Medicine Göttingen Germany, Göttingen
Hospital Universitario Virgen Macarena, Seville
Universitätsklinikum Essen, Essen
Universitätsklinikum Münster, Münster
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara, Pisa
Hôpital Claude Huriez, Lille
Hospices Civils de Lyon - Hôpital Louis Pradel, Bron
Universitätsklinikum Tübingen, Tübingen
Centre Hospitalier National D'ophtalmologie Des Quinze Vingts, Paris
Azienda Ospedaliera Universitaria Federico II, Napoli
USC Roski Eye Institute - Los Angeles, Los Angeles
ARNAS Garibaldi - PO Garibaldi-Centro, Catania
The Private Practice of Raymond Douglas, MD - Beverly Hills, Beverly Hills
Stanford University, Palo Alto
University of Colorado - Eye Center - PPDS, Aurora
Bascom Palmer Eye Institute, Miami
Mayo Clinic - PPDS, Rochester
Washington University, St Louis
Casey Eye Institute - OHSU, Portland
Moorfields Eye Hospital - PPDS, London
Imperial College Healthcare NHS Trust - PPDS, London
University Hospital of Cardiff, Cardiff
Royal Victoria Infirmary, Newcastle upon Tyne
Southampton University Hospitals NHS Trust, Southampton
Lead Sponsor
Amgen
INDUSTRY