A Safety, Tolerability and Efficacy Study of Veligrotug (VRDN 001) in Healthy Volunteers and Participants With Thyroid Eye Disease (TED) ( THRIVE )
NCT ID: NCT05176639
Last Updated: 2025-07-18
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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COMPLETED
PHASE3
113 participants
INTERVENTIONAL
2021-12-03
2025-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Phase 3 Cohort (THRIVE) veligrotug (VRDN-001)
Participants with TED will be randomized to either veligrotug (VRDN-001) 10mg/kg or placebo.
VRDN-001 Phase 3 Cohort (THRIVE)
5 IV Infusions of veligrotug (VRDN-001) 10mg/kg
Phase 3 Cohort (THRIVE) VRDN-001 Placebo
Participants with TED will be randomized to either veligrotug (VRDN-001) 10mg/kg or placebo.
VRDN-001 Placebo
5 IV Infusions of veligrotug (VRDN-001) placebo
Interventions
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VRDN-001 Phase 3 Cohort (THRIVE)
5 IV Infusions of veligrotug (VRDN-001) 10mg/kg
VRDN-001 Placebo
5 IV Infusions of veligrotug (VRDN-001) placebo
Eligibility Criteria
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Inclusion Criteria
* Must have 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 used systemic corticosteroids or selenium within 2 weeks prior to Day 1
* Must not have received rituximab, tocilizumab or other immunosuppressive agents or any other therapy for TED within 8 weeks prior to Day 1
* Must not have received an investigational agent for any condition with 8 weeks prior to Day 1
* Must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the Investigator would confound interpretation of the study results
* Must not have had previous orbital irradiation or surgery for TED in the study eye
* Must not have a history of inflammatory bowel disease
* Must not have a history of or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
* Female TED participants must not be pregnant or lactating
Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions.
18 Years
ALL
Yes
Sponsors
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Viridian Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Colorado - Department of Ophthalmology
Aurora, California, United States
The Private Office of Raymond Douglas
Beverly Hills, California, United States
USC Roski Eye Institute
Los Angeles, California, United States
MACRO Trials, Inc.
Los Angeles, California, United States
Amy Patel Jain, MD
Newport Beach, California, United States
Byers Eye Institute/Stanford University
Palo Alto, California, United States
Senta Clinic
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Sina Medical Center
Homestead, Florida, United States
Med-Care Research Inc.
Miami, Florida, United States
Edward Jenner Research Group Center LLC
Plantation, Florida, United States
Sarasota Retina Institue
Sarasota, Florida, United States
Vision Medical Research Inc.
Orland Park, Illinois, United States
University Health Diabetes, Endocrinology & Nephrology Center
Kansas City, Kansas, United States
KU Medical Center, University of Kansas
Kansas City, Kansas, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
Weymouth, Massachusetts, United States
Fraser Eye Care Center
Fraser, Michigan, United States
Kahana Oculoplastic & Orbital Surgery
Livonia, Michigan, United States
University of Minnesota, Department of Ophthalmology and Visual Neurosciences
Minneapolis, Minnesota, United States
Advanced Research International, LLC
Las Vegas, Nevada, United States
Rutgers-New Jersey Medical School-Newark
Newark, New Jersey, United States
New York Eye Ear Infirmary of Mount Sinai
New York, New York, United States
Baylor College of Medicine (BCM)-Opthalmology
Houston, Texas, United States
Neuro-Eye Clinical Trials
Houston, Texas, United States
Neuro-Ophthalmology of Texas PLLC
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
West Virgina University Eye Insitute
Morgantown, West Virginia, United States
Sydney Eye Hospital
Sydney, , Australia
North Shore Eye Surgery
Sydney, , Australia
CHU d'Angers
Angers, , France
CH Nice
Nice, , France
Centre Hospitalier National D'ophtalmologie
Paris, , France
AP-HP- Hopital de la Pitie Salpetriere
Paris, , France
Universitatsmedizin Gottingen
Göttingen, , Germany
Johannes Gutenberg-University Medical Center
Mainz, , Germany
NZOZ E-Vita
Bialystok, , Poland
Specjakistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, , Poland
Santa Familia PTG Lodz
Lodz, , Poland
Panstwowy Instytut Medycsny MSWiA
Warsaw, , Poland
4 Wojskowy Szpital Kliniczny z Polikinika SP ZOZ
Wroclaw, , Poland
Clinica Bonanova de Cirugia Ocular
Barcelona, , Spain
Hospital Arruzafa
Córdoba, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Complexo Hospiralario Universitario de Santiago-Hospital Medico-Ciruxico de Conxo
Santiago, , Spain
Hospital Universitatio Virgen De La Macarena, Servicio de Oftalmologia
Seville, , Spain
Hospital Universitario Miguel Servet, Servicio de Paseo Isabel La Catdlica1
Zaragoza, , Spain
Northwick Park Hospital
London, United Kingdon, United Kingdom
Western Eye Hospital Imperial College NHS trust
London, United Kingdon, United Kingdom
Guy's and St. Thomas NHS Trust
London, United Kingdon, United Kingdom
Countries
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Other Identifiers
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VRDN-001-101
Identifier Type: -
Identifier Source: org_study_id
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