The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Study medication taken twice daily by mouth
Placebo taken twice daily by mouth
Thrive Health Research
Beverly Hills, California, United States
UC San Diego Health
La Jolla, California, United States
UCLA
Los Angeles, California, United States
Byers Eye Institute - Stanford University
Palo Alto, California, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Percentage of Subjects who are Proptosis Responders at Week 24
Time frame: 24 weeks
Change from Baseline in Proptosis to Week 24 (Study Eye)
Time frame: 24 weeks
Percentage of Subjects who are Diplopia Responders at Week 24
Time frame: 24 weeks
Percentage of Subjects who are Overall Responders at Week 24
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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