Active, moderate-to-severe TED
Conditions
Brief summary
TED Proptosis 1. Primary endpoints: Change in proptosis from Baseline to Week 24 in the trial eye using the Hertel exophthalmometer
Detailed description
Pharmacokinetics 1. Secondary endpoints: - exposure to Lu AG22515 as observed: Cmax, tmax, Ctrough - exposure to Lu AG22515 as modelled: AUC, CL, V, and t½; Safety 1. TEAEs 2. changes from Baseline in clinical safety laboratory test values, vital signs, weight, and ECG parameter values 3. PCS clinical safety laboratory test values, vital signs, weight changes, and ECG parameter values; Immunogenicity 1. presence of anti-Lu AG22515 antibodies (ADAs)
Interventions
None listed
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TED Proptosis 1. Primary endpoints: Change in proptosis from Baseline to Week 24 in the trial eye using the Hertel exophthalmometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics 1. Secondary endpoints: - exposure to Lu AG22515 as observed: Cmax, tmax, Ctrough - exposure to Lu AG22515 as modelled: AUC, CL, V, and t½; Safety 1. TEAEs 2. changes from Baseline in clinical safety laboratory test values, vital signs, weight, and ECG parameter values 3. PCS clinical safety laboratory test values, vital signs, weight changes, and ECG parameter values; Immunogenicity 1. presence of anti-Lu AG22515 antibodies (ADAs) | — |
Countries
Bulgaria, Germany, Poland, Spain
Outcome results
None listed