A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED)
Thyroid Eye Disease
About this trial
This is an interventional treatment trial for Thyroid Eye Disease focused on measuring Graves, Thyroid Eye Disease, Thyroid-Associated Ophthalmopathy, Dysthyroid Ophthalmopathy, Graves Eye Disease, Graves Orbitopathy, Myopathic Ophthalmopathy, Congestive Ophthalmopathy, Edematous Ophthalmopathy, Infiltrative Ophthalmopathy
Eligibility Criteria
Inclusion Criteria: Must have moderate to severe chronic TED with documented evidence of ocular symptoms or signs that began > 15 months prior to screening Must have Clinical Activity Score (CAS) of (0-7) item scale for the study (more proptotic) eye Must agree to use highly effective contraception as specified in the protocol Female TED participants must have a negative serum pregnancy test Key Exclusion Criteria: Must not have received prior treatment with another anti-IGF-1R monoclonal antibody Must not have used oral corticosteroids 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 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 inflammatory bowel disease Must not have a history or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing l loss Must not have received an investigational agent for any condition Female TED participants must not be pregnant or lactating
Sites / Locations
- Eye Wellness Center- Neuro-Eye Clinical Trials, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
VRDN-001 10 mg/kg
Placebo Drug
Drug: 5 Infusions of VRDN-001 10 mg/kg
Placebo Drug: 5 Infusions of placebo