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

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

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called VRDN-003 to see how effective, safe, and tolerable it is for people with active Thyroid Eye Disease (TED), a condition that can cause swelling and discomfort around the eyes. If you or someone you know has moderate to severe TED with noticeable symptoms that started within the last 15 months, and a specific score indicating the activity of the disease, you might be eligible to participate. The trial is open to individuals aged 18 and older, regardless of gender, who can meet certain health criteria.

Participants in this trial can expect to receive the study drug and will be monitored closely for any side effects or changes in their condition. It's important to note that there are specific requirements for joining, such as not having received certain treatments for TED or other health conditions in recent weeks. Additionally, female participants must not be pregnant or breastfeeding. Overall, this trial aims to find better treatments for TED and help improve the quality of life for those affected by this condition.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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 a 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
• 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 who 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.