An Open-label Study (OLE) for Non-responders of VRDN-001-101 (NCT05176639) and VRDN-001-301 (NCT06021054)
Completed · Phase 3
Conditions studied: Thyroid Eye Disease
In brief
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 patients 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.
Key facts
- Study ID
- NCT06179875
- Run by
- Viridian Therapeutics, Inc.
- People needed
- 143
- Starts
- 2024-01-31
- Expected to finish
- 2025-06-23
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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