A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
NCT ID: NCT06812325
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
321 participants
INTERVENTIONAL
2025-02-03
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VRDN-003 every 4 weeks
6 subcutaneous administrations of VRDN-003
VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
VRDN-003 every 8 weeks
3 subcutaneous administrations of VRDN-003 and 3 subcutaneous administrations of placebo
VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Placebo
Placebo injections that appear identical to VRDN-003 injections but have no active drug.
Interventions
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VRDN-003
VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).
Placebo
Placebo injections that appear identical to VRDN-003 injections but have no active drug.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Viridian Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Catalina Eye Care
Tuscon, Arizona, United States
United Medical Research Institute
Inglewood, California, United States
Orbital Plastics
Newport Beach, California, United States
California Eye Specialists Medical Group INC
Pasadena, California, United States
FOMAT Medical Research
Pismo Beach, California, United States
Pacific Neuroscience Institute
Santa Monica, California, United States
Pacific Neuroscience Institute at Saint John's Physician Partners
Torrance, California, United States
C A Clinical Trial Corp.
Cape Coral, Florida, United States
Herco Medical and Research Center
Coral Gables, Florida, United States
Alfa Medical Research
Davie, Florida, United States
D H Doral Research Center
Doral, Florida, United States
Eye Centers of Florida
Fort Myers, Florida, United States
Sina Medical Center
Homestead, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Southern Clinical Research LLC
Miami, Florida, United States
Retreat Medical Research
Miami, Florida, United States
Continental Clinical Research
Miami, Florida, United States
Edward Jenner Research Group LLC
Plantation, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Advanced Quality Medical Research
Orland Park, Illinois, United States
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, United States
Fraser Eye Care Center
Fraser, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Missouri Kansas City
Kansas City, Missouri, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Jackson Clinic
Jackson, Tennessee, United States
DFW Clinical Trials
Carrollton, Texas, United States
Neuro Eye Clinical Trials
Houston, Texas, United States
Pioneer Research Solutions Inc.
Houston, Texas, United States
San Antonio Clinical Trials
San Antonio, Texas, United States
Eyeplastx
San Antonio, Texas, United States
Elevate Clinical Research
Seabrook, Texas, United States
Servicde d'Endocrinologie, Diabetologieet Nutrition Centre Hospitalier Universitaire d'Angers
Angers, , France
Abeillon du Payrat
Bron, , France
Hôpital La Pitiélsalpêtrière
Paris, , France
Charite Universitatsmeizin Berlin KoR Campus Virchow Klinikum
Berlin, , Germany
Universitatsklinikum Essen
Essen, , Germany
Universitaetsmedizin Goettingen
Göttingen, , Germany
Johannes Gutenberg University Medical Center Department of Medicine 1
Mainz, , Germany
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Okulistyki, Centrum Badań Klinicznych
Bialystok, , Poland
Optimum Profesorskie Centrum Okulistyki Sp. z o. o.
Gdansk, , Poland
Centrum Medyczne Pratia Gdynia
Gdynia, , Poland
Santa Familia PTG Lodz
Lodz, , Poland
ETG Lublin
Lublin, , Poland
Centrum Medyczne Pulawska Sp. z o.o.
Piaseczno, , Poland
Warszawski Szpital Okulistyczny
Warsaw, , Poland
Polimedica PTG
Warsaw, , Poland
Hospital Provincial de Conxo
A Coruña, , Spain
Institut Català de Retina
Barcelona, , Spain
Hospital La Arruzafa
Córdoba, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Clinica Universidad de Navarre
Navarrés, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Miguel Servet Consultas de Oftalmologia
Zaragoza, , Spain
Gazi University Medical Faculty Hospital
Ankara, , Turkey (Türkiye)
Hacettepe Univeristy Medical Fculty Hospital
Ankara, , Turkey (Türkiye)
Akdeniz Üniversitesi Tıp Fakültesi Göz Hastalıkları Anabilim Dalı
Antalya, , Turkey (Türkiye)
Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi Göz Hastalıkları Kliniği
Istanbul, , Turkey (Türkiye)
University Hospitals Bristol and Weston NHS Foundation Trust Clinical Research Unit
Bristol, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Moorefields Eye Hospital NHS Foundation Trust
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Countries
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Other Identifiers
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VRDN-003-303
Identifier Type: -
Identifier Source: org_study_id