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A Safety, Tolerability, and Efficacy Study of Veligrotug (VRDN 001) in Participants With Thyroid Eye Disease (TED)
Sponsor: Viridian Therapeutics, Inc.
Summary
The investigational drug, veligrotug (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 thyroid eye disease (TED). The primary objective of this clinical trial is to establish the safety, tolerability, and efficacy of veligrotug, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of veligrotug in active TED participants who received 10 milligrams (mg)/kilogram (kg).
Official title: A Safety, Tolerability, and Efficacy Study of Veligrotug, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor in Subjects With Thyroid Eye Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
113
Start Date
2022-11-16
Completion Date
2025-03-27
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
Veligrotug
5 IV Infusions of veligrotug 10 mg/kg
Placebo
5 IV Infusions of veligrotug matched placebo
Locations (53)
University of Colorado - Department of Ophthalmology
Aurora, California, United States
The Private Office of Raymond Douglas
Beverly Hills, California, United States
USC Roski Eye Institute
Los Angeles, California, United States
MACRO Trials, Inc.
Los Angeles, California, United States
Amy Patel Jain, MD
Newport Beach, California, United States
Byers Eye Institute/Stanford University
Palo Alto, California, United States
Senta Clinic
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Sina Medical Center
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
Advanced 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 Virgina University Eye Institute
Morgantown, West Virginia, United States
Sydney Eye Hospital
Sydney, Australia
North Shore Eye Surgery
Sydney, Australia
CHU d'Angers
Angers, France
CH Nice
Nice, France
Centre Hospitalier National D'ophtalmologie
Paris, France
AP-HP- Hopital de la Pitie Salpetriere
Paris, France
Universitatsmedizin Gottingen
Göttingen, Germany
Johannes Gutenberg-University Medical Center
Mainz, Germany
NZOZ E-Vita
Bialystok, Poland
Specjakistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, Poland
Santa Familia PTG Lodz
Lodz, Poland
Panstwowy Instytut Medycsny MSWiA
Warsaw, Poland
4 Wojskowy Szpital Kliniczny z Polikinika SP ZOZ
Wroclaw, Poland
Clinica Bonanova de Cirugia Ocular
Barcelona, Spain
Hospital Arruzafa
Córdoba, Spain
Clinica Universidad de Navarra
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Complexo Hospiralario Universitario de Santiago-Hospital Medico-Ciruxico de Conxo
Santiago, Spain
Hospital Universitatio Virgen De La Macarena, Servicio de Oftalmologia
Seville, Spain
Hospital Universitario Miguel Servet, Servicio de Paseo Isabel La Catdlica1
Zaragoza, Spain
Northwick Park Hospital
London, United Kingdon, United Kingdom
Western Eye Hospital Imperial College NHS trust
London, United Kingdon, United Kingdom
Guy's and St. Thomas NHS Trust
London, United Kingdon, United Kingdom