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A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
Sponsor: Viridian Therapeutics, Inc.
Summary
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.
Official title: A Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Thyroid Eye Disease (TED)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
231
Start Date
2024-05-23
Completion Date
2026-01-19
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
Veligrotug
5 infusions of veligrotug
Locations (50)
United Medical Research Institute
Inglewood, California, United States
Advancing Research International, LLC
Los Angeles, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
Cockerham Eye Consultants, PC
San Diego, California, United States
FOMAT Medical Research
Santa Maria, California, United States
University of Colorado - Dept of Ophthalmology
Aurora, Colorado, United States
Sina Medical Center LLC
Homestead, Florida, United States
Med-Care Research Inc.
Miami, Florida, United States
Edward Jenner Research Group Center LLC
Plantation, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Vision Medical Research Inc.
Orland Park, Illinois, United States
University Health Diabetes, Endocrinology & Nephrology Center
Kansas City, Kansas, United States
KU Medical Center, University of Kansas
Kansas City, Kansas, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
Weymouth, Massachusetts, United States
Fraser Eye Care Center
Fraser, Michigan, United States
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, United States
University of Minnesota, Department of Ophthalmology and Visual Neurosciences
Minneapolis, Minnesota, United States
Advancing Research International, LLC
Las Vegas, Nevada, United States
Rutgers- New Jersey Medical School- Newark
Newark, New Jersey, United States
New York Eye Ear Infirmary of Mount Sinai
New York, New York, United States
Baylor College of Medicine (BCM) - Ophthalmology
Houston, Texas, United States
Neuro-Eye Clinical Trials
Houston, Texas, United States
Neuro-Ophthalmology of Texas, PLLC
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Sydney Eye Hospital
Sydney, Australia
North Shore Eye Surgery
Sydney, Australia
CHU d'Angers
Angers, France
Centre Hospitalier National D'ophtalmologie
Des Quinze Vingts Paris, France
CH Nice
Nice, France
AP-HP - Hôpital de la Pitié Salpétrière
Paris, France
Universitätsmedizin Göttingen
Göttingen, Germany
Johannes Gutenberg-University Medical Center
Mainz, Germany
NZOZ E-Vita
Bialystok, Poland
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, Poland
Santa Familia PTG Lodz
Lódz, Poland
Panstwowy Instytut Medyczny MSWiA
Warsaw, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Wroclaw, Poland
Clinica Bonanova de Cirugia Ocular
Barcelona, Spain
Hospital Arruzafa
Córdoba, Spain
Clínica Universidad de Navarra
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo
Santiago de Compostela, A Coruña, Spain
Hospital Universitario Virgen De La Macarena, Servicio de Oftalmología
Seville, Spain
Miguel Servet University Hospital, Clinical Trials Unit
Zaragoza, Spain
Northwick Park Hospital
London, United Kingdom
Western Eye Hospital, Imperial College NHS Trust
London, United Kingdom
Guy's and St. Thomas NHS Trust
London, United Kingdom