Interventional, Open-label, Single-group, Long-term Follow-up Trial of Lu AG22515 in Patients With Moderate-to-severe Thyroid Eye Disease
This trial will evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease (TED). TED is an autoimmune condition closely related to Graves' Disease. In people with TED, the healthy tissue behind and around the eye becomes inflamed and swollen. One of the key symptoms of TED is proptosis (bulging eyes). The main goal of this trial is to learn whether treatment with Lu AG22515 improves proptosis in participants with moderate-to-severe TED.
• The participant has Graves' disease associated Thyroid Eye Disease (TED) symptoms characterized by:
• ophthalmologic symptom onset \<12 months prior to the Baseline Visit
• proptosis ≥3 millimeter (mm) above normal for race and sex measured using the Hertel exophthalmometer (at the Screening Visit and the Baseline Visit) in the most severe eye
• Clinical Activity Score (CAS) ≥3 in the most severe eye at the Screening Visit.
• The participants must be euthyroid or have mild hypo- or hyperthyroidism (defined as free thyroxin \[FT4\] and/or free triiodothyronine \[FT3\] levels not exceeding the normal limits +/-50%) at the Screening Visit.