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
Proptosis response is defined as a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
Time frame: 24 weeks
Percentage of Subjects Who Are Overall Responders at Week 24
Overall response is defined as a \>= 2-point reduction from baseline CAS and \>= 2 mm reduction in proptosis in the primary study eye at week 24 without deterioration (\>= 2-point increase) in CAS or deterioration (\>= 2 mm increase) of proptosis in the contralateral non-study eye. In the event of death, the latest CAS/proptosis observations will be carried forward. Missing values of CAS and proptosis measurement in the primary study eye and contralateral non-study eye at week 24 are multiple imputed by using all available prior CAS/proptosis measures, smoking status and treatment group.
Time frame: 24 weeks
Percentage of Subjects With a CAS Value of 0 or 1 at Week 24
A CAS value of 0 or 1 in primary study eye at week 24. In the event of death, the latest CAS observation will be carried forward. Missing values of CAS at week 24 are multiple imputed by using all available prior CAS measures, smoking status and treatment group
Time frame: 24 weeks
Change From Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.
Change from baseline to week 24 in Graves' Ophthalmology Quality of Life (GO-QoL) overall score or to last assessed value in case of death. Missing values of GO-QoL overall score up to week 24 are multiple imputed by using all available prior GO-QoL overall score measures, smoking status and treatment group. Overall scale was measured from 0 minimum to 100 maximum (0 is worse health state and 100 is best health state)
Time frame: 24 weeks
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