Thyroid Eye Disease
Conditions
Brief summary
Proptosis responder rate at Extension study Week 24. The definition of responder rate, unchanged from the main VGN-TED-301 study, is the percentage of subjects with a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
Detailed description
1. Mean change from Baseline through Week 24 in proptosis measurement in the primary study eye. 2. Overall responder rate (percentage of subjects with ≥ 2-point reduction in Clinical Activity Scale (CAS) and ≥ 2mm reduction in proptosis from Baseline, provided there is no corresponding deterioration (≥ 2- point/ mm increase) in CAS or proptosis in the contralateral non-study eye through Week 24.
Interventions
DRUGPlacebo to match 75 mg linsitinib film-coated tablet. Placebo tablets are formulated to match the physical characteristics of the active tablets. The placebo drug product is a tablet formulation compressed from a direct powder blend containing microcrystalline cellulose
Sponsors
Sling Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proptosis responder rate at Extension study Week 24. The definition of responder rate, unchanged from the main VGN-TED-301 study, is the percentage of subjects with a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change from Baseline through Week 24 in proptosis measurement in the primary study eye. 2. Overall responder rate (percentage of subjects with ≥ 2-point reduction in Clinical Activity Scale (CAS) and ≥ 2mm reduction in proptosis from Baseline, provided there is no corresponding deterioration (≥ 2- point/ mm increase) in CAS or proptosis in the contralateral non-study eye through Week 24. | — |
Countries
Italy, Spain
Outcome results
None listed