A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.
CAS of both eyes ≤ 2 points during the screening period and baseline;
According to the subject's medical history, CAS of both eyes ≤ 2 points at least 6 months before screening, or according to the subject's chief complaint or medical history, with all of the following characteristics: no progression of proptosis and no new diplopia caused by TED at least 6 months before screening or no progression of diplopia caused by TED and no new inflammatory TED symptoms;
According to the subject's chief complaint or medical history, the first TED diagnosis before screening was ≥ 2 years and < 10 years.
At baseline, the eyeball protrusion of the study eye decreased by ≥2 mm compared with the screening period;
Subjects who have been previously diagnosed with DON, or who are determined by the investigator to have DON during screening (defined as: orbital MRI/CT showing orbital apex crowding or optic nerve compression, and at least 2 of the following ophthalmological examination abnormalities that cannot be explained by other reasons: ① best corrected visual acuity [BCVA] < 0.8 or BCVA decreased by ≥ 2 lines compared with before the onset; ② abnormal pupillary light reflex or relative pupillary afferent disorder; ③ color vision abnormalities; ④ optic disc edema and optic disc pallor on fundus examination; ⑤ visual field loss; ⑥ visual evoked potential with prolonged latency and/or decreased amplitude);
Patients with corneal ulcers that are judged by the researchers to have no relief after treatment;
Planned to receive orbital radiotherapy or surgical treatment for TED (including orbital decompression, strabismus correction, eyelid correction, etc.) at any time before baseline or during the study period;
Parallel
IBI311
DrugTeprotumumab N01 injection (code name IBI311)
Placebo
DrugPlacebo
Proptosis response rate of the study eye
Proptosis response rate (i.e., percentage of participants with a ≥ 2 mm decrease from baseline in proptosis in the study eye and without a ≥ 2 mm increase of proptosis in the fellow eye) of the study eye at Week 24
Change from baseline of proptosis in the study eye
The Change from baseline of proptosis in the study eye at Week 24
Time to first achieve proptosis response in the study eye
Time to first proptosis response in the study eye at Week 24.
Change from baseline in CAS in the study eye
Change from baseline in CAS in the study eye at Week 24.
Diplopia responder rate
Diplopia responder rate (percentage of subjects with ≥ 1-grade improvement in diplopia) at Week 24.
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