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An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301
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 thyroid eye disease (TED). The primary objectives of this clinical trial are to provide open-label access to VRDN-001 for participants who were previously non-responders at 3 weeks post the fifth IV infusion (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies and assess the safety and efficacy of VRDN-001 in participants who were previously treated with VRDN-001 or placebo.
Official title: An Open-label Study for Participants Who Are Non-responders at the End of Treatment Assessment on the VRDN-001-101 and VRDN-001-301 Pivotal Studies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
139
Start Date
2024-01-31
Completion Date
2025-06-23
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
Veligrotug
Veligrotug 10 mg/kg (5 infusions of Veligrotug 10 mg/kg)
Locations (45)
Advancing Research International, LLC
Los Angeles, California, United States
USC Eye Institute
Los Angeles, California, United States
Advancing Research International, LLC
Newport Beach, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
Cockerham Eye Consultants, PC
San Diego, California, United States
University of Miami Miller School of Medicine, Bascom Palmer Eye Institute
Miami, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Vision Medical Research
Oak Lawn, Illinois, United States
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, United States
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, United States
Ophthalmic Plastic, Reconstructive, Orbital and Cosmetic Surgery
Las Vegas, Nevada, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
The Center for Eye and Facial Plastic Surgery
Somerset, New Jersey, United States
Hospital of the University of Pennsylvania Perleman Center
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Neuro-Eye Clinical Trials
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Washington Medical Center
Seattle, Washington, United States
Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie
Montpellier, Hérault, France
Centre Hospitalier Universitaire De Nantes G.R. Laenne
Saint-Herblain, Loire-Atlantique, France
CHU Angers
Angers, France
Universitatmedizin Gottingen
Göttingen, Lower Saxony, Germany
Charite - Universitatsmedizin Berlin KoR, Campus Virchow Klinikum, Klinik tor Augenheilkunde
Berlin, Germany
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Universitatsklinikum Essen AoR - Klinik fur Augenheilkunde
Essen, Germany
University Medical Center Freiburg
Freiburg im Breisgau, Germany
Amsterdam UMC
Amsterdam, Netherlands
Centrum Medyczne Piasta
Wałbrzych, Piasta, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, Poland
Centrum Medyczne Pulawska
Piaseczno, Poland
Hospital Arruzafa. Servicio de Oftalmologia
Córdoba, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Virgen de la Macarena
Seville, Spain
Hospital Universitario Miguel Servel
Zaragoza, Spain
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
Gazi University Medical Faculty Hospital
Ankara, Turkey (Türkiye)
Akdeniz University Medical Faculty Hospital
Antalya, Turkey (Türkiye)
Marmara University Faculty of Medicine
Istanbul, Turkey (Türkiye)
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, London, United Kingdom
University Hospital Bristol and Weston NHS Foundation Trust- Bristol Eye Hospital
Bristol, United Kingdom
Imperial College Healthcare NHS Trust Western Eye Hospital
London, United Kingdom
Guy's and St. Thomas Trust
London, United Kingdom
Newcastle Eye Centre
Newcastle, United Kingdom