An Open-label Study (OLE) for Non-responders of VRDN-001-101 (NCT05176639) and VRDN-001-301 (NCT0… (NCT06179875) | Clinical Trial Compass
CompletedPhase 3
An Open-label Study (OLE) for Non-responders of VRDN-001-101 (NCT05176639) and VRDN-001-301 (NCT06021054)
United States143 participantsStarted 2024-01-31
Plain-language summary
The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objectives of this clinical trial are to provide open-label access to VRDN-001 for participants who were previously non-responders at 3 weeks post the fifth IV infusion (i.e., 15 weeks) in the VRDN-001-101 (THRIVE) and VRDN-001-301 (THRIVE-2) pivotal studies and assess the safety and efficacy of VRDN-001 in participants who were previously treated with VRDN-001 or placebo.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
✓. 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
✓. Not require immediate surgical 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 urine pregnancy test at screening
✓. Be willing and able to comply with all the requirements of the protocol for the entire duration of the study
Exclusion criteria
✕. Have received prior treatment with another anti-IGF-1R agent
What they're measuring
1
Proptosis Responder Rate in the most proptotic eye
✕. Have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose
✕. 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
✕. Have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
✕. Have had previous orbital irradiation or decompression surgery involving excision of fat for TED to the study eye's orbit
✕. Have abnormal hearing test before first dose. Have a history of ear conditions considered significant by study doctor