An Open-label Study for Non-responders of VRDN-001-101 and VRDN-001-301 (OLE)

Launched by VIRIDIAN THERAPEUTICS, INC. · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with Thyroid Eye Disease (TED) who did not respond to earlier treatments in two previous studies (referred to as THRIVE and THRIVE-2). The goal is to see if this new treatment can help these participants improve their symptoms, particularly the bulging of the eyes, after they have completed at least five treatment infusions.

To be eligible for this trial, participants must have completed the earlier studies and been identified as non-responders at the end of treatment. They should also be willing to use effective contraception during the study and must be female participants with a negative pregnancy test. However, those who have received certain medications or treatments for TED in the past few weeks, or have specific ear health issues, will not be eligible. Participants can expect regular assessments to monitor their progress and will be part of an open-label study, meaning everyone will know what treatment they are receiving.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Be able to understand the study procedures and the risks involved and be willing to provide written informed consent before the first study-related activity
• • 2. Have completed at least 5 IV infusions and assessments required to determine proptosis responder status 3 weeks post the fifth IV infusion (i.e., Week 15) as defined in either the VRDN-001-101 or VRDN-001-301 pivotal studies
• • 3. Been a participant in either the VRDN-001-101 or VRDN-001-301 studies and found to be a non-responder as defined within the VRDN-001-101 or VRDN-001-301 study
• • 4. Not require immediate surgical ophthalmological or orbital surgery in the study eye for any reason
• • 5. Must agree to use highly effective contraception as specified in the protocol
• • ⦁ Female TED participants must have a negative urine pregnancy test at screening
• • 6. Be willing and able to comply with all the requirements of the protocol for the entire duration of the study
• Key Exclusion Criteria:
• Participants must not:
• • 1. Have received prior treatment with another anti-IGF-1R agent
• • 2. Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
• • 3. Have received other immunosuppressive drugs or another investigational agent for any condition, including TED (other than VRDN-001 or placebo associated with the VRDN-001-101 or VRDN-001-301 pivotal studies), or any other therapy for TED, within 8 weeks prior to first dose
• • 4. Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
• • 5. Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit
• • 6. Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor