The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
150 mg linsitinib is taken twice daily by mouth for 24 weeks
0 mg placebo taken twice daily by mouth for 24 weeks
Advancing Research International
Las Vegas, Nevada, United States
RECRUITINGMeasure percentage of participants who are Proptosis Responders at Week 24
The proptosis responder rate is the percentage of participants with a ≥ 2 mm reduction of proptosis from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
Time frame: 24 weeks
Mean change from Baseline in Proptosis to Week 24
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in proptosis measurement in the primary study eye.
Time frame: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the overall responder rate at Week 24
Overall responder rate (percentage of participants with ≥ 2-point reduction in 7 point CAS and ≥ 2 mm reduction in proptosis from Baseline in the primary study eye), provided there is no corresponding deterioration (≥ 2-point/mm increase) in CAS or proptosis in the contralateral non-study eye at Week 24.
Time frame: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in the GO-QoL questionnaire overall score.
Mean change from Baseline to Week 24 in the Graves' Orbitopathy Quality of Life questionnaire (GO-QoL) questionnaire overall score (0-100 where higher scores are a better outcome).
Time frame: 24 Weeks
Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.
Percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.
Time frame: 24 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.