CompletedPhase 3
An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED)
Key facts
- Who runs it
- Viridian Therapeutics, Inc.
- Where
- Boston, Burlington, Chicago, East Lansing, Houston, Las Vegas, Livonia, Los Angeles, Miami, Newark, Newport Beach, Oak Lawn, Palo Alto, Philadelphia, San Diego, Sarasota, Seattle, Somerset, and St Louis, United StatesSee the 23 sitesAlso in 8 other countries, 34 sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 188 people enrolled
- Started
- 1 Nov 2023
- Ended
- 25 Jul 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Veligrotug
- Placebo
- Record updated
- 13 August 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
- Must have had a clinical diagnosis of TED, with any CAS (0-7)
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
Who cannot take part
- Must not have received prior treatment with another anti-IGF-1R therapy
- Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
- Must not have received other immunosuppressive drugs or another investigational agent for any condition, including TED, or any other therapy for TED, within 8 weeks prior to first dose
- Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
- Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
- Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results
- Must not have inflammatory bowel disease
- Must not have abnormal baseline audiometry Pure Tone Average (PTA) assessment or history of significant (as determined by the Investigator) ear pathology, relevant ear surgery or hearing loss
- Female TED participants must not be pregnant or lactating
Where in United States
Also in 8 other countries, 34 sites
- Massachusetts Eye and EarBoston, United StatesNo longer taking part
- Ophthalmic Consultants of BostonBoston, United StatesNo longer taking part
- University of Vermont Medical CenterBurlington, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Michigan State University Department of NeurologyEast Lansing, 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
- Steven Leibowitz, MD.Las Vegas, United StatesNo longer taking part
- Kahana Oculoplastic and Orbital SurgeryLivonia, United StatesNo longer taking part
- Advancing Research International, LLCLos Angeles, United StatesNo longer taking part
- USC Roski Eye InstituteLos Angeles, United StatesNo longer taking part
- Bascom Palmer Eye Institute - Ophthalmology - MiamiMiami, United StatesNo longer taking part
- Rutgers New Jersey Medical SchoolNewark, United StatesNo longer taking part
- Amy Patel Jain, MDNewport Beach, United StatesNo longer taking part
- Family Eye Physicians, LtdOak Lawn, United StatesNo longer taking part
- Stanford Byers Eye InstitutePalo Alto, United StatesNo longer taking part
- Department of Ophthalmology, University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Wills Eye HospitalPhiladelphia, United StatesNo longer taking part
- Cockerham Eye Consultants, PCSan Diego, United StatesNo longer taking part
- Sarasota Retina InstituteSarasota, United StatesNo longer taking part
- Harborview Medical CenterSeattle, United StatesNo longer taking part
- The Center for Eye and Facial Plastic SurgerySomerset, United StatesNo longer taking part
- Washington University School of Medicine in St Louis - OphthalmologySt Louis, United StatesNo longer taking part
About the trial
What the trial wants to find out
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).
The 2 groups in the trial
- VeligrotugTreatment being tested
Participants will receive veligrotug 10 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.
- PlaceboTreatment being tested
Participants will receive placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
- Record updated
- 13 August 2026