A Safety, Tolerability, and Efficacy Study of Veligrotug (VRDN 001) in Participants With Thyroid Eye Disease (TED)
Key facts
- Where
- Aurora, Beverly Hills, Boston, Burlington, Fraser, Homestead, Houston, Kansas City, Las Vegas, Livonia, Los Angeles, Miami, Minneapolis, Morgantown, New York, Newark, Newport Beach, Orland Park, Palo Alto, Plantation, San Diego, San Francisco, Sarasota, and Weymouth, United StatesSee the 29 sites
- Phase
- Phase 3
Where in United States
- University of ColoradoAurora, United StatesNo longer taking part
- University of Colorado - Department of OphthalmologyAurora, United StatesNo longer taking part
- The Private Office of Raymond DouglasBeverly Hills, United StatesNo longer taking part
- Massachusetts Eye and EarBoston, United StatesNo longer taking part
- University of Vermont Medical CenterBurlington, United StatesNo longer taking part
- Fraser Eye Care CenterFraser, United StatesNo longer taking part
- Sina Medical CenterHomestead, United StatesNo longer taking part
- Baylor College of Medicine (BCM)-OphthalmologyHouston, United StatesNo longer taking part
- Neuro-Eye Clinical TrialsHouston, United StatesNo longer taking part
- Neuro-Ophthalmology of Texas PLLCHouston, United StatesNo longer taking part
- KU Medical Center, University of KansasKansas City, United StatesNo longer taking part
- University Health Diabetes, Endocrinology & Nephrology CenterKansas City, United StatesNo longer taking part
- Advanced Research International, LLCLas Vegas, United StatesNo longer taking part
- Kahana Oculoplastic & Orbital SurgeryLivonia, United StatesNo longer taking part
- MACRO Trials, Inc.Los Angeles, United StatesNo longer taking part
- USC Roski Eye InstituteLos Angeles, United StatesNo longer taking part
- Med-Care Research Inc.Miami, United StatesNo longer taking part
- University of Minnesota, Department of Ophthalmology and Visual NeurosciencesMinneapolis, United StatesNo longer taking part
- West Virgina University Eye InstituteMorgantown, United StatesNo longer taking part
- New York Eye Ear Infirmary of Mount SinaiNew York, United StatesNo longer taking part
- Rutgers-New Jersey Medical School-NewarkNewark, United StatesNo longer taking part
- Amy Patel Jain, MDNewport Beach, United StatesNo longer taking part
- Vision Medical Research Inc.Orland Park, United StatesNo longer taking part
- Byers Eye Institute, Stanford UniversityPalo Alto, United StatesNo longer taking part
- Edward Jenner Research Group Center LLCPlantation, United StatesNo longer taking part
- Senta ClinicSan Diego, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
- Sarasota Retina InstituteSarasota, United StatesNo longer taking part
- Ophthalmic Consultants of BostonWeymouth, United StatesNo longer taking part
Trial details
- Who runs it
- Viridian Therapeutics, Inc.
- Trial code
- NCT05176639
- Record updated
- 13 August 2026
- Original description
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).Read full original descriptionShow less
A Safety, Tolerability, and Efficacy Study of Veligrotug, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor in Subjects With Thyroid Eye Disease
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).
Inclusion: Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening; Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye; Must agree to use highly effective contraception as specified in the protocol; Female TED participants must have a negative serum pregnancy test at screening.
Exclusion: Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED; Must not have used systemic corticosteroids or selenium within 2 weeks prior to Day 1; Must not have received rituximab, tocilizumab or other immunosuppressive agents or any other therapy for TED within 8 weeks prior to Day 1; Must not have received an investigational agent for any condition within 8 weeks prior to Day 1; Must not have had previous orbital irradiation or surgery for TED in the study eye; Female TED participants must not be pregnant or lactating; Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions; Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results; Must not have a history of inflammatory bowel disease; Must not have a history of or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss.