Status:
COMPLETED
An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301
Lead Sponsor:
Viridian Therapeutics, Inc.
Conditions:
Thyroid Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- Participants must not:
- Have received prior treatment with another anti-IGF-1R agent
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2025
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT06179875
Start Date
February 1 2023
End Date
June 23 2025
Last Update
August 1 2025
Active Locations (45)
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1
Advancing Research International, LLC
Los Angeles, California, United States, 90023
2
USC Eye Institute
Los Angeles, California, United States, 90033
3
Advancing Research International, LLC
Newport Beach, California, United States, 90023
4
Stanford Byers Eye Institute
Palo Alto, California, United States, 94303