A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)

Launched by VIRIDIAN THERAPEUTICS, INC. · Jan 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called VRDN-003 to see how safe it is and how well people with Thyroid Eye Disease (TED) can tolerate it. TED is a condition that affects the eyes and can cause symptoms like bulging eyes or discomfort. The trial is currently looking for participants aged 18 to 80 who have been diagnosed with TED. To join, they should not need any immediate eye surgery and must agree to use effective birth control if they are women.

Participants in this trial can expect to receive the investigational drug and will be monitored closely by doctors throughout the study to check for any side effects or issues. It’s important to note that certain people, such as those who have recently received other specific treatments for TED or related conditions, may not be eligible to participate. This study aims to gather valuable information that could help improve future treatments for TED, so if you or someone you know is dealing with this condition, it could be a great opportunity to consider.

Gender

ALL

Eligibility criteria

• 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
• Exclusion Criteria:
• • Must not have received prior treatment with another anti-IGF-1R therapy
• • Must not have received systemic corticosteroids 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 8 weeks prior to first dose
• • Must not have received an investigational agent for any condition, including TED, within 8 weeks 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 significant by study doctor
• • Must not have a history of inflammatory bowel disease
• • Female TED participants must not be pregnant or breastfeeding