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 objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED.
A randomized, controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
5 infusions of VRDN-001 10 mg/kg
5 infusions of VRDN-001 3 mg/kg
Treatment Emergent Adverse Event (TEAE) incidence rate
Time frame: Week 15
Change from baseline in proptosis in the study eye as measured by exophthalmometer
Time frame: Week 15
Treatment Emergent Adverse Event (TEAE) incidence rate
Time frame: Week 52
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