A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease

Exclusion Criteria

• •Subjects will be ineligible for study participation if they meet any of the following criteria:
• •1. Baseline CAS decreased by ≥ 2 points, or baseline proptosis decreased by ≥ 2 mm as compared with screening.
• •2. Visual function impairment due to optic neuropathy, defined as ≥ 2 lines of vision loss, new visual field defect, or color vision impairment secondary to optic nerve involvement within the past 180 days;
• •3. Corneal ulcers with no relief after treatment as determined by the investigator;
• •4. TED patients who need immediate corticosteroid therapy, orbital radiotherapy, or orbital decompression;
• •5. At any time prior to baseline or during the study period planned to receive orbital radiation therapy or TED surgery, including orbital decompression, strabismus surgery, and eyelid retraction correction;
• •6. Poorly controlled thyroid function, which was defined as free triiodothyronine (FT3) or free tetraiodothyronine (FT4) deviated more than 50% from the normal reference range of the local research center laboratory at screening.
• •7. Either ear had a history of tinnitus or other hearing impairment; or abnormal pure tone audiometry (defined as mean bone conduction threshold \[0.5, 1, 2, 4 kHz\] ≥25 dB or any bone conduction threshold ≥ 40 dB);
• •8. Poorly controlled diabetes at screening, defined as HbA1C ≥ 9.0% at screening, or any new medication for diabetes within 60 days prior to screening, or any dose adjustment for diabetes drugs \> 10%);
• •9. Systemic use of glucocorticoids ≤ 30 days prior to screening;
• •10. Periorbital use of glucocorticoids ≤ 90 days prior to screening;
• •11. Systemic use of immunosuppressants ≤ 90 days prior to screening;
• •12. Use glucocorticoid eye drops or immunosuppressive eye drops ≤ 30 days prior to screening
• •12\. Use IBI311 or TEPEZZA at any time prior to screening; 13 Use CD20 antibody ≤ 1 year prior to screening, or IL-6R antibody ≤ 180 days prior to screening; 14. Subjects had participated in other interventional clinical trials ≤ 90 days prior to screening, or attempting to participate in other clinical trials during the study period.