Overview
A randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001 in participants with chronic thyroid eye disease (TED)
Description
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)
Eligibility
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