Active, not recruitingPhase 3
A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
Key facts
- Who runs it
- Viridian Therapeutics, Inc.
- Where
- Cape Coral, Carrollton, Coral Gables, Davie, Doral, East Weymouth, Fort Myers, Fraser, Homestead, Houston, Inglewood, Jackson, Jacksonville, Kansas City, Miami, Newark, Newport Beach, Orland Park, Pasadena, Pismo Beach, Plantation, Rochester, San Antonio, Santa Monica, Sarasota, Seabrook, Torrance, and Tuscon, United StatesSee the 32 sitesAlso in 6 other countries, 32 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 320 people enrolled
- Started
- 3 Feb 2025
- Ended
- Oct 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- VRDN-003
- Placebo
- Record updated
- 22 May 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 14 criteriaShow less
Who can take part
- Have a clinical diagnosis of TED with or without proptosis and with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003
- Not require immediate ophthalmological or orbital surgery in the study eye for any reason
- 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 or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose
- Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose
- Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) 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 which in the study doctor's opinion, would interfere with interpretation of study results
- Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
- Must not have a history of inflammatory bowel disease
- Female TED participants must not be pregnant or breastfeeding
Where in United States
Also in 6 other countries, 32 sites
- C A Clinical Trial Corp.Cape Coral, United StatesNo longer taking part
- DFW Clinical TrialsCarrollton, United StatesNo longer taking part
- Herco Medical and Research CenterCoral Gables, United StatesNo longer taking part
- Alfa Medical ResearchDavie, United StatesNo longer taking part
- D&H Doral Research CenterDoral, United StatesNo longer taking part
- Ophthalmic Consultants of BostonEast Weymouth, United StatesNo longer taking part
- Eye Centers of FloridaFort Myers, United StatesNo longer taking part
- Fraser Eye Care CenterFraser, United StatesNo longer taking part
- Sina Medical CenterHomestead, United StatesNo longer taking part
- Neuro-Eye Clinical TrialsHouston, United StatesNo longer taking part
- Pioneer Research Solutions, Inc.Houston, United StatesNo longer taking part
- United medical research instituteInglewood, United StatesNo longer taking part
- Jackson ClinicJackson, United StatesNo longer taking part
- East Coast Institute for Research, LLCJacksonville, United StatesNo longer taking part
- University of Missouri-Kansas CityKansas City, United StatesNo longer taking part
- Continental Clinical ResearchMiami, United StatesNo longer taking part
- Retreat Medical ResearchMiami, United StatesNo longer taking part
- Southern Clinical Research LLCMiami, United StatesNo longer taking part
- Rutgers New Jersey Medical SchoolNewark, United StatesNo longer taking part
- Orbital PlasticsNewport Beach, United StatesNo longer taking part
- Advanced Quality Medical ResearchOrland Park, United StatesNo longer taking part
- California Eye Specialists Medical Group, Inc.Pasadena, United StatesNo longer taking part
- FOMAT Medical ResearchPismo Beach, United StatesNo longer taking part
- Edward Jenner Research Group LLCPlantation, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesNo longer taking part
- EyeplastxSan Antonio, United StatesNo longer taking part
- San Antonio Clinical TrialsSan Antonio, United StatesNo longer taking part
- Pacific Neuroscience InstituteSanta Monica, United StatesNo longer taking part
- Sarasota Retina InstituteSarasota, United StatesNo longer taking part
- Elevate Clinical ResearchSeabrook, United StatesNo longer taking part
- Pacific Neuroscience Institute at Saint John's Physician PartnersTorrance, United StatesNo longer taking part
- Catalina Eye CareTuscon, United StatesNo longer taking part
About the trial
What the trial wants to find out
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).
The 2 groups in the trial
- VRDN-003 every 4 weeksTreatment being tested
6 subcutaneous administrations of VRDN-003
Treatment: VRDN-003
- VRDN-003 every 8 weeksTreatment being tested
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
Treatment: VRDN-003 and Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Double-masked, Controlled, Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
- Record updated
- 22 May 2026