This is a prospective study designed to evaluate the efficacy and safety of Teprotumumab N01 in patients with Thyroid Eye Disease (TED). Eligible patients will receive Teprotumumab N01 and will be assessed using clinical and imaging parameters before and after treatment, with each patient serving as their own control. The primary endpoint is the overall response rate at Week 24.
Able to comply with the study procedures and voluntarily sign the written informed consent form;
Male or female subjects aged 18-80 years (inclusive) at screening;
Body weight between 45 and 100 kg (inclusive);
Meet internationally recognized diagnostic criteria for TED who are receiving teprotumumab N01 treatment；
Poorly controlled thyroid function, defined as FT3 or FT4 deviating by more than 50% from the normal reference range;
Receipt of radioactive iodine therapy within 3 months prior to screening;
Thyroid dysfunction-related optic neuropathy, defined as any of the following occurring within the past 6 months due to optic nerve involvement: a decrease in best-corrected visual acuity (BCVA) of ≥2 lines, new visual field defects, or secondary color vision impairment;
Corneal ulcer without improvement after treatment, as judged by the investigator;
Peking University Third Hospital
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator