Active, not recruitingPhase 3
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
Key facts
- Who runs it
- Viridian Therapeutics, Inc.
- Where
- Asheville, Atlanta, Canoga Park, Cape Coral, Durham, East Weymouth, Fraser, Houston, Huntington Beach, Inglewood, Kansas City, Kissimmee, Las Vegas, Livonia, Los Angeles, Lynwood, Miami, Morgantown, Newark, Newport Beach, Orland Park, Palo Alto, Pasadena, San Diego, Sarasota, Scottsdale, Seattle, and Sparks, United StatesSee the 34 sitesAlso in 4 other countries, 14 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 132 people enrolled
- Started
- 27 Aug 2024
- Expected to end
- 15 Nov 2026
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- VRDN-003
- Placebo
- Record updated
- 18 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 14 criteriaShow less
Who can take part
- 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 a 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
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 who must not be pregnant or breastfeeding; NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol
Where in United States
Also in 4 other countries, 14 sites
- Asheville Clinical ResearchAsheville, United StatesNo longer taking part
- Agile Clinical Research Trials, LLCAtlanta, United StatesNo longer taking part
- Alliance Research Institute, Canoga ParkCanoga Park, United StatesNo longer taking part
- C&A Clinical Trials CorpCape Coral, United StatesNo longer taking part
- Duke Eye CenterDurham, United StatesNo longer taking part
- Opthalmic Consultants of BostonEast Weymouth, United StatesNo longer taking part
- Fraser Eye Care CenterFraser, United StatesNo longer taking part
- Baylor College of Medicine, Alkek Eye CenterHouston, United StatesNo longer taking part
- Gulf Coast Clinical TrialsHouston, United StatesNo longer taking part
- Neuro-Eye Clinical TrialsHouston, United StatesNo longer taking part
- Marvel Clinical ResearchHuntington Beach, United StatesNo longer taking part
- United medical research instituteInglewood, United StatesNo longer taking part
- University HealthKansas City, United StatesNo longer taking part
- Ilumina Medical ResearchKissimmee, United StatesNo longer taking part
- S.L. OfficeLas Vegas, United StatesNo longer taking part
- Kahana Oculoplastic & Orbital SurgeryLivonia, United StatesNo longer taking part
- Advancing Research International, LLCLos Angeles, United StatesNo longer taking part
- Roski Eye Institute, Keck School of Medicine, USCLos Angeles, United StatesNo longer taking part
- Alliance Research Institute, LynwoodLynwood, United StatesNo longer taking part
- Anmed Health Services LLCMiami, United StatesNo longer taking part
- Continental Clinical ResearchMiami, United StatesNo longer taking part
- Hype Clinical Research LLCMiami, United StatesNo longer taking part
- Med-Care ResearchMiami, United StatesNo longer taking part
- West Virginia University Eye InstituteMorgantown, United StatesNo longer taking part
- Rutgers New Jersey Medical SchoolNewark, United StatesNo longer taking part
- A.P.J. OfficeNewport Beach, United StatesNo longer taking part
- Vision Medical ResearchOrland Park, United StatesNo longer taking part
- Byers Eye Institute at Stanford UniversityPalo Alto, United StatesNo longer taking part
- Pasadena Clinical TrialsPasadena, United StatesNo longer taking part
- Cockerham Eye Consultants, PCSan Diego, United StatesNo longer taking part
- Sarasota Retina InstituteSarasota, United StatesNo longer taking part
- Scottsdale Clinical TrialsScottsdale, United StatesNo longer taking part
- University of Washington Eye InstituteSeattle, United StatesNo longer taking part
- Vector Clinical TrialsSparks, 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, VRDN-003, in participants with active Thyroid Eye Disease (TED).
The 3 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
- Placebo every 4 weeksPlacebo, for comparison
6 subcutaneous administrations of placebo
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- REVEAL-1 - A Phase 3, Randomized, Double-masked, Placebo-controlled, Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
- Record updated
- 18 August 2026