A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified March 2026 by Viridian Therapeutics, Inc.
Sponsor
Viridian Therapeutics, Inc.
Information Provided by (Responsible Party)
Viridian Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT06384547
Other Study ID Numbers:
VRDN-001-303
First Submitted
April 21, 2024
First Posted
April 24, 2024
Last Update Posted
April 29, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).

Condition or DiseaseIntervention/Treatment
Thyroid Eye Disease
Drug: VRDN-001 10 mg/kgDrug: VRDN-001 3 mg/kg

Study Design

Study TypeInterventional
Actual Enrollment231 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Randomized, Controlled, Safety and Tolerability Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Thyroid Eye Disease (TED)
Study Start DateMay 22, 2024
Actual Primary Completion DateApril 30, 2025
Actual Study Completion DateJanuary 18, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
VRDN-001 10 mg/kg
5 infusions of VRDN-001 10 mg/kg
Drug: VRDN-001 10 mg/kg
5 infusions of VRDN-001 10 mg/kg
5 infusions of VRDN-001 3 mg/kg
5 infusions of VRDN-001 3 mg/kg
Drug: VRDN-001 3 mg/kg
5 infusions of VRDN-001 3 mg/kg

Outcome Measures

Primary Outcome Measures
  1. Treatment Emergent Adverse Event (TEAE) incidence rate
Secondary Outcome Measures
  1. Change from baseline in proptosis in the study eye as measured by exophthalmometer
  2. Treatment Emergent Adverse Event (TEAE) incidence rate

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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 treatment
Must agree to use highly effective contraception method as specified in the protocol
Female TED participants must have a negative serum pregnancy test
Not require immediate ophthalmological or orbital surgery in the study eye for any reason
Exclusion Criteria
Must not have received prior treatment with another anti-IGF-1R therapy
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 within 8 weeks prior to Day 1
Must not have received any other therapy for TED within 8 weeks prior to Day 1
Must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication
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 decompression surgery involving excision of fat for TED in the study eye's orbit
Must not have inflammatory bowel disease
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 received an investigational agent for any condition within 8 weeks prior to Day 1
Female TED participants must not be pregnant or lactating

Contacts and Locations

Sponsors and CollaboratorsViridian Therapeutics, Inc.
Locations
United Medical Research Institute | Inglewood California, United States, 90301Advancing Research International, LLC | Los Angeles California, United States, 90023Stanford Byers Eye Institute | Palo Alto California, United States, 94303Cockerham Eye Consultants, PC | San Diego California, United States, 92108FOMAT Medical Research | Santa Maria California, United States, 93454University of Colorado - Dept of Ophthalmology | Aurora Colorado, United States, 80045Sina Medical Center LLC | Homestead Florida, United States, 33034Med-Care Research Inc. | Miami Florida, United States, 33125Edward Jenner Research Group Center LLC | Plantation Florida, United States, 33317Sarasota Retina Institute | Sarasota Florida, United States, 34231Vision Medical Research Inc. | Orland Park Illinois, United States, 60462University Health Diabetes, Endocrinology & Nephrology Center | Kansas City Kansas, United States, 64108KU Medical Center, University of Kansas | Kansas City Kansas, United States, 66103Massachusetts Eye and Ear | Boston Massachusetts, United States, 02114Ophthalmic Consultants of Boston | Weymouth Massachusetts, United States, 02189Fraser Eye Care Center | Fraser Michigan, United States, 48026Kahana Oculoplastic & Orbital Surgery | Livonia Michigan, United States, 48152University of Minnesota, Department of Ophthalmology and Visual Neurosciences | Minneapolis Minnesota, United States, 55455Advancing Research International, LLC | Las Vegas Nevada, United States, 89144Rutgers- New Jersey Medical School- Newark | Newark New Jersey, United States, 07103New York Eye Ear Infirmary of Mount Sinai | New York New York, United States, 10003Baylor College of Medicine (BCM) - Ophthalmology | Houston Texas, United States, 77030Neuro-Eye Clinical Trials | Houston Texas, United States, 77074Neuro-Ophthalmology of Texas, PLLC | Houston Texas, United States, 77074University of Vermont Medical Center | Burlington Vermont, United States, 05401West Virginia University Eye Institute | Morgantown West Virginia, United States, 26506Sydney Eye Hospital | Sydney , Australia, 2000North Shore Eye Surgery | Sydney , Australia, 2065CHU d'Angers | Angers , France, 49100Centre Hospitalier National D'ophtalmologie | Des Quinze Vingts Paris , France, 75012CH Nice | Nice , France, 06000AP-HP - Hôpital de la Pitié Salpétrière | Paris , France, 75013Universitätsmedizin Göttingen | Göttingen , Germany, 37075Johannes Gutenberg-University Medical Center | Mainz , Germany, 55131NZOZ E-Vita | Bialystok , Poland, 15-879Specjalistyczny Osrodek Okulistyczny Oculomedica | Bydgoszcz , Poland, 85-870Santa Familia PTG Lodz | Lódz , Poland, 90-302Panstwowy Instytut Medyczny MSWiA | Warsaw , Poland, 02-5074 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ | Wroclaw , Poland, 53-114Clinica Bonanova de Cirugia Ocular | Barcelona , Spain, 08022Hospital Arruzafa | Córdoba , Spain, 14012Clínica Universidad de Navarra | Madrid , Spain, 28027Hospital Universitario Ramón y Cajal | Madrid , Spain, 28034Clinica Universidad de Navarra | Pamplona , Spain, 31008Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo | Santiago de Compostela, A Coruña , Spain, 15706Hospital Universitario Virgen De La Macarena, Servicio de Oftalmología | Seville , Spain, 41071Miguel Servet University Hospital, Clinical Trials Unit | Zaragoza , Spain, 50009Northwick Park Hospital | London , United Kingdom, HA1 3UJWestern Eye Hospital, Imperial College NHS Trust | London , United Kingdom, NW1 5QHGuy's and St. Thomas NHS Trust | London , United Kingdom, SE1 7EH