Disease (TED)
Conditions
Brief summary
Proptosis responder rate at Week 24.
Detailed description
Change from Baseline to Week 24 in proptosis measurement in the primary study eye., Overall responder rate in Clinical Activity Scale (CAS) or proptosis in the contralateral non-study eye at Week 24., Percentage of subjects with a CAS value of 0 or 1 at Week 24 in the primary study eye., Mean change from Baseline to Week 24 in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score.
Interventions
DRUGplacebo 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 Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to Week 24 in proptosis measurement in the primary study eye., Overall responder rate in Clinical Activity Scale (CAS) or proptosis in the contralateral non-study eye at Week 24., Percentage of subjects with a CAS value of 0 or 1 at Week 24 in the primary study eye., Mean change from Baseline to Week 24 in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score. | — |
Countries
Italy, Spain
Outcome results
None listed