An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED)
NCT ID: NCT06625411
Last Updated: 2025-09-30
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
117 participants
INTERVENTIONAL
2024-08-27
2026-11-15
Brief Summary
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Detailed Description
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Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.
Conditions
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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
All participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections.
Placebo every 4 weeks
6 subcutaneous administrations of placebo
Placebo
All participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections.
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
All participants will receive the same number of injections to maintain masking. Masking will be maintained by the use of placebo injections that appear identical to VRDN-003 injections.
Eligibility Criteria
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Inclusion Criteria
* 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
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 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.
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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Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Alliance Research Institute - Canoga Park
Canoga Park, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
United Medical Research Institute
Inglewood, California, United States
Advancing Research International, LLC
Los Angeles, California, United States
Roski Eye Institute, Keck School of Medicine, USC
Los Angeles, California, United States
Alliance Research Institute - Lynwood
Lynwood, California, United States
A.P.J. Office
Newport Beach, California, United States
Byers Eye Institute at Stanford University
Palo Alto, California, United States
Pasadena Clinical Trials
Pasadena, California, United States
Senta Clinic
San Diego, California, United States
C&A Clinical Trials Corp
Cape Coral, Florida, United States
Ilumina Medical Research
Kissimmee, Florida, United States
Med-Care Research
Miami, Florida, United States
Continental Clinical Research
Miami, Florida, United States
Hype Clinical Research LLC
Miami, Florida, United States
Anmed Health Services LLC
Miami, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Vision Medical Research
Orland Park, Illinois, United States
Opthalmic Consultants of Boston
East Weymouth, Massachusetts, United States
Fraser Eye Care Center
Fraser, Michigan, United States
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, United States
University Health
Kansas City, Missouri, United States
S.L. Office
Las Vegas, Nevada, United States
Vector Clinical Trials
Sparks, Nevada, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Asheville Clinical Research
Asheville, North Carolina, United States
Duke Eye Center
Durham, North Carolina, United States
Baylor College of Medicine/Alkek Eye Center
Houston, Texas, United States
Gulf Coast Clinical Trials
Houston, Texas, United States
Neuro-Eye Clinical Trials
Houston, Texas, United States
University of Washington, Eye institute
Seattle, Washington, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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VRDN-003-301
Identifier Type: -
Identifier Source: org_study_id
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