An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED)

Launched by VIRIDIAN THERAPEUTICS, INC. · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called VRDN-003 to see how effective it is, as well as how safe and tolerable it is for people with Chronic Thyroid Eye Disease (TED). TED is a condition that affects the eyes and can cause symptoms like bulging eyes, discomfort, and vision problems. The trial is currently looking for participants aged between 18 and 80 who have moderate to severe TED, with symptoms that started more than 15 months ago. To be eligible, participants need to agree to use effective birth control if they are women, and they must not have had certain other treatments for TED or other significant health conditions recently.

Participants in the trial will receive the study drug and will be monitored closely by the research team to track how well it works and any side effects they may experience. It's important to know that there are specific guidelines about who can join, such as not having had recent treatments for TED or other serious eye issues. This trial aims to improve treatment options for TED, and participants will play a crucial role in helping researchers understand the potential benefits and risks of this new medication.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
• • 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 significant by study doctor
• • Must not have a history of inflammatory bowel disease
• • Female TED participants must not be pregnant or breastfeeding
• • NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.