Thyroid Eye Disease
Conditions
Brief summary
Change from baseline at week 9999 in proptosis measurement by an exophthalmometer in the study eye
Detailed description
Subject incidence of treatment-emergent adverse events, including serious adverse events, PK parameters including but not limited to maximum observed concentration (Cmax), time to maximum observed concentration (Tmax), area under the concentration time curve (AUC) over the dosing interval, accumulation following multiple dosing, and if feasible, half-life (t1/2) as data permits., Subject incidence of antidrug antibodies (ADAs), Proptosis response status in the study eye 9999 proptosis in the fellow eye) at week 9999, Mean change from Baseline at Week 9999 in the GO-QoL Visual Functioning (VF) subscale score, Mean change from Baseline at Week 9999 in the GO-QoL Appearance (A) subscale score
Interventions
DRUGAMG 732
DRUGPlacebo for AMG 732 will consist of site-sourced normal saline in sterile single-use vials or ampoules
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at week 9999 in proptosis measurement by an exophthalmometer in the study eye | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject incidence of treatment-emergent adverse events, including serious adverse events, PK parameters including but not limited to maximum observed concentration (Cmax), time to maximum observed concentration (Tmax), area under the concentration time curve (AUC) over the dosing interval, accumulation following multiple dosing, and if feasible, half-life (t1/2) as data permits., Subject incidence of antidrug antibodies (ADAs), Proptosis response status in the study eye 9999 proptosis in the fellow eye) at week 9999, Mean change from Baseline at Week 9999 in the GO-QoL Visual Functioning (VF) subscale score, Mean change from Baseline at Week 9999 in the GO-QoL Appearance (A) subscale score | — |
Countries
France, Germany, Greece, Italy, Poland, Spain
Outcome results
None listed