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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
VRDN-001 10 mg/kg (5 infusions of VRDN-001 10 mg/kg)
Advancing Research International, LLC
Los Angeles, California, United States
USC Eye Institute
Los Angeles, California, United States
Advancing Research International, LLC
Newport Beach, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
Cockerham Eye Consultants, PC
San Diego, California, United States
Proptosis Responder Rate in the most proptotic eye
Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥ 2 mm from baseline \[without a corresponding increase of ≥ 2 mm in the other eye\]) as measured by exophthalmometer
Time frame: Week 15
Change from Baseline in proptosis in the most proptotic eye
Change from Baseline in proptosis in the most proptotic eye as measured by exophthalmometer
Time frame: Week 15
Proptosis Responder Rate in the most proptotic eye
Proptosis Responder Rate in the most proptotic eye as measured by MRI/CT
Time frame: Week 15
Change from baseline in proptosis in the most proptotic eye
Change from baseline in proptosis in the most proptotic eye as measured by MRI/CT
Time frame: Week 15
Clinical Activity Responder Rate in the most proptotic eye
Clinical Activity Responder Rate in the most proptotic eye as measured by exophthalmometer
Time frame: Week 15
Overall Responder Rate in the most proptotic eye
Overall Responder Rate in the most proptotic eye as measured by exophthalmometer and Clinical Activity Responder Rate in the most proptotic eye as measured by exophthalmometer
Time frame: Week 15
Diplopia Responder Rate
Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0).
Time frame: Week 15
Diplopia Resolution Rate
Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0).
Time frame: Week 15
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