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

Completed · Phase 3

Conditions studied: Thyroid Eye Disease

In brief

The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.

Key facts

Study ID

NCT06384547

Run by

Viridian Therapeutics, Inc.

People needed

231

Starts

2024-05-23

Expected to finish

2026-01-19

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• United Medical Research Institute — Inglewood, California, United States
• Advancing Research International, LLC — Los Angeles, California, United States
• Stanford Byers Eye Institute — Palo Alto, California, United States
• Cockerham Eye Consultants, PC — San Diego, California, United States
• FOMAT Medical Research — Santa Maria, California, United States
• University of Colorado - Dept of Ophthalmology — Aurora, Colorado, United States
• Sina Medical Center LLC — Homestead, Florida, United States
• Med-Care Research Inc. — Miami, Florida, United States
• Edward Jenner Research Group Center LLC — Plantation, Florida, United States
• Sarasota Retina Institute — 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
• Advancing 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) - Ophthalmology — 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

Full record on ClinicalTrials.gov

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