Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Viridian Therapeutics, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have moderate to severe active TED with documented evidence of ocular symptoms or signs that began within 15 months prior to screening
Must have Clinical Activity Score (CAS) of ≥ 3 on the 7-item scale for the study eye
Must agree to use highly effective contraception as specified in the protocol
Female TED participants must have a negative serum pregnancy test at screening
You may not be if
Must not have received prior treatment with another anti-IGF-1R therapy or any investigational agent for TED
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 or 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 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 of inflammatory bowel disease
Must not have a history of or screening audiometry assessment of clinically significant (as determined by investigator) ear pathology, relevant ear surgery, or hearing loss
Female TED participants must not be pregnant or lactating
Note: Prior thyroidectomy, radioactive iodine (RAI) treatment, or orbital decompression surgery limited to bone only are NOT exclusions.
Clareo Health | A Safety, Tolerability, and Efficacy Study of Veligrotug (VRDN 001) in Participants With Thyroid Eye Disease (TED)
