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
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a clinical diagnosis of TED with or without proptosis and with any clinical activity score (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 at screening
Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
You may not be 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.
Female TED participants must not be pregnant or lactating.
Clareo Health | A Randomized, Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED)
