The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Study medication taken twice daily by mouth
Bascom Palmer Eye Institute
Miami, Florida, United States
RECRUITINGWest Virginia University Eye Institute
Morgantown, West Virginia, United States
RECRUITINGPercentage of Subjects who are Proptosis Responders at Week 24
Percentage of subjects with a ≥ 2 mm reduction of proptosis from baseline as determined by exophthalmometer
Time frame: 24 weeks
Change from Baseline in Proptosis to Week 24 (Study Eye)
Change from baseline in reduction of proptosis from baseline as determined by exophthalmometer
Time frame: 24 weeks
Percentage of Subjects who are Overall Responders at Week 24
Percentage of Subjects with a response of ≥ 2 mm reduction of proptosis at Week 24 as determined by exophthalmometer
Time frame: 24 weeks
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)
Time frame: 24 weeks
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24
Time frame: 24 weeks
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