Ireland
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Active, not recruiting Phase 3

A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

NCT06812325 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2025-02-03
Last updated
2026-05-22

Condition(s) studied

Thyroid Eye Disease (TED)

Investigational drug(s) / intervention(s)

VRDN-003 →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.

Study summary

This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key 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 VRDN-003 * 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 Key Exclusion Criteria: * 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 must not be pregnant or breastfeeding

Primary outcome measure(s)

  • Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24 — Week 24
    Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24

Trial sites (64)

FacilityCityRegionStatus
Catalina Eye Care Tuscon Arizona
United Medical Research Institute Inglewood California
Orbital Plastics Newport Beach California
California Eye Specialists Medical Group INC Pasadena California
FOMAT Medical Research Pismo Beach California
Pacific Neuroscience Institute Santa Monica California
Pacific Neuroscience Institute at Saint John's Physician Partners Torrance California
C A Clinical Trial Corp. Cape Coral Florida
Herco Medical and Research Center Coral Gables Florida
Alfa Medical Research Davie Florida
D H Doral Research Center Doral Florida
Eye Centers of Florida Fort Myers Florida
Sina Medical Center Homestead Florida
East Coast Institute for Research, LLC Jacksonville Florida
Southern Clinical Research LLC Miami Florida
Retreat Medical Research Miami Florida
Continental Clinical Research Miami Florida
Edward Jenner Research Group LLC Plantation Florida
Sarasota Retina Institute Sarasota Florida
Advanced Quality Medical Research Orland Park Illinois
Ophthalmic Consultants of Boston East Weymouth Massachusetts
Fraser Eye Care Center Fraser Michigan
Mayo Clinic Rochester Rochester Minnesota
University of Missouri Kansas City Kansas City Missouri
Rutgers New Jersey Medical School Newark New Jersey
Jackson Clinic Jackson Tennessee
DFW Clinical Trials Carrollton Texas
Neuro Eye Clinical Trials Houston Texas
Pioneer Research Solutions Inc. Houston Texas
San Antonio Clinical Trials San Antonio Texas
Eyeplastx San Antonio Texas
Elevate Clinical Research Seabrook Texas
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

+ 24 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06812325 on ClinicalTrials.gov ↗ ← All trials in Spain