A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (NCT06812325) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
United States321 participantsStarted 2025-02-03
Plain-language summary
This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with Thyroid Eye Disease (TED).
Who can participate
Age range18 Years – 75 Years
SexALL
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Key Inclusion Criteria:
* 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 VRDN-003
* Not require immediate ophthalmological or orbital surgery in the study eye for any reason.
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening
Key Exclusion Criteria:
* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose.
* Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose
* Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
* Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
* Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
* Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
* Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered si…
What they're measuring
1
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24