Thyroid Eye Disease
Conditions
Interventions
Experimental group:The treatment period will commence on Day 1 and continue through Week 24. Throughout this period, subjects will return to the study site at 3-week intervals for a total of 8 schedul
Control group:Receipt of other treatment regimens (e.g., glucocorticoids, tocilizumab, other immunosuppressants, ± radiotherapy)
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Comply with the trial protocol and voluntarily sign the informed consent form. 2. Male or female subjects aged 18-80 years (inclusive) at screening. 3. Body weight between 45-100 kg (inclusive). 4. At screening and baseline, have at least one eye with CAS = 2 of the following manifestations: eyelid retraction >= 2 mm, moderate or severe soft tissue involvement, exophthalmos >= upper limit of normal (ULN) +3 mm, intermittent or constant diplopia. 6. Female subjects must either be of non-childbearing potential or have a negative blood pregnancy test at screening and agree to use contraception from screening until 180 days after the last dose; male subjects must agree to use contraception from screening until 180 days after the last dose.
Exclusion criteria
Exclusion criteria: 1. During screening, based on the subject's chief complaint or medical records, the time from the first onset of active TED symptoms is > 2 years; 2. Decreased best-corrected visual acuity due to optic neuropathy (defined as a decrease in best-corrected visual acuity of >= 2 lines due to optic neuropathy within the past 30 days), new visual field defects, or color vision impairment secondary to optic nerve involvement; 3. Corneal ulcer without resolution after treatment, as determined by the investigator; 4. Poorly controlled thyroid function, defined as free triiodothyronine (FT3) or free thyroxine (FT4) levels at screening that deviate by more than 50% from the local central laboratory's normal reference range; 5. Presence of any other pre-existing disease, metabolic disorder, abnormal physical examination, or abnormal clinical laboratory findings that reasonably suggest a disease or condition that may contraindicate the use of the investigational drug, affect the interpretation of study results, or place the subject at high risk for treatment complications, including but not limited to: confirmed or clinically suspected diagnosis of inflammatory bowel disease, coagulation disorders, history of acute cardiovascular or cerebrovascular disease or treatment within 180 days prior to screening (including but not limited to: cerebrovascular accident, transient ischemic attack, acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention [excluding diagnostic angiography], severe arrhythmias, etc.), history of treated or untreated malignancy within the past 5 years (excluding successfully resected skin squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ with no evidence of metastasis), severe systemic infection, proptosis not caused by TED, etc.; 6. History of tinnitus or other hearing impairment in either ear; 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 8 × ULN, or total bilirubin (TBIL) > 5 × ULN; 8. Glomerular filtration rate (GFR) = 9.0% at screening); 10. Use of oral or intravenous corticosteroids within the past 14 days for the treatment of TED, or peribulbar/orbital corticosteroid injections within the past 14 days; 11. Use of corticosteroids within the past 14 days for reasons other than TED, with the exception of topical use (cutaneous, intranasal, inhaled); 12. Received interleukin-6 antibody therapy within the past 90 days; 13. Received anti-CD20 antibody therapy within the past 180 days; 14. Previously received Teprotumumab therapy; 15. Oral or intravenous use of any other immunosuppressant within the past 14 days; 16. Participation in other interventional clinical trials within the past 90 days (or within 5 half-lives of the investigational drug, whichever is longer; vitamins and minerals excluded), or attempted participation in other clinical trials during the study period; 17. Female subjects who are pregnant or lactating; 18. Known allergy to the investigational drug or placebo components, or a history of allergy to other monoclonal antibodies; 19. Other reasons deemed by the investigator as making the subject unsuitable for participation in this
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proptosis response rate of the study eye at Weeks 12 and 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the study eye's CAS value at Weeks 12 and 24;Change from baseline in proptosis of the study eye at Weeks 12 and 24;Diplopia response rate at Weeks 12 and 24;The incidence, relationship to the investigational product, and severity of ocular and systemic adverse events, treatment-emergent adverse events, and serious adverse events;Change from baseline in proptosis as measured by MRI at Weeks 12 and 24;Change from baseline in extraocular muscle volume and maximum thickness as measured by MRI at Weeks 12 and 24;Change from baseline in orbital fat tissue volume and maximum thickness as measured by MRI at Weeks 12 and 24;Change from baseline in lacrimal gland volume and maximum thickness as measured by MRI at Weeks 12 and 24;Change from baseline in orbital tissue signal intensity as measured by MRI at Weeks 12 and 24;Change from baseline in palpebral fissure width (height) at Weeks 12 and 24;Change from baseline in ocular motility limitation at Weeks 12 and 24;Proportion of subjects diagnosed by the investigator with Thyroid Eye Disease-associated optic neuropathy at Weeks 12 and 24;Proportion of subjects diagnosed by the investigator with exposure keratopathy at Weeks 12 and 24;Change from baseline in the total score of the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire at Weeks 12 and 24; | — |
Countries
China
Contacts
Public ContactHaixia Guan
Guangdong Provincial People's Hospital
Outcome results
None listed