Thyroid Associated Ophthalmopathy
Conditions
Interventions
Experimental drug group 10mg/kg:Intravenously administered once every 3 weeks (Q3W)
Experimental drug group 20mg/kg:Intravenously administered once every 3 weeks (Q3W)
placebo group:Intravenously administered once every 3 weeks (Q3W)
Sponsors
Shanghai Ninth people's Hospital,Shanghai jiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled: 1. Male or female between the ages of 18 and 75 (including the threshold value) at the time of signing the informed consent; 2.40 kg= weight =100 kg; 3. According to the Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Related Eye Diseases (2022), TED was diagnosed as moderate to severe, requiring the study eyes (eyes with more severe exophthalmia) to have an exophthalmia = normal +3 mm (=18 mm) with any of the following manifestations: eyelid retraction =2 mm, moderate or severe soft tissue involvement, intermittent or persistent diplopia; 4. TED requirements during the active period: CAS score of the study eye =3 (7 points in total), and according to the subject's chief complaint or medical records, the time of first onset of TED symptoms =9 months after screening; 5. TED requirements in inactive period: CAS score of the eyes of the study was 1 year after screening; 6. If the subject is female, it should be a fertile woman who is infertile or whose blood pregnancy test during the screening period is negative and who has agreed to use contraception within 90 days from the screening period to the last dose; Male subjects should agree to use contraception from the screening period to 90 days after the last dose; 7.Can comply with the requirements during the trial, can perform all physical and laboratory tests as specified in the trial protocol, and can report subjective symptoms.
Exclusion criteria
Exclusion criteria: Subjects will not be admitted to the study if they meet any of the following exclusions: 1. Best corrected vision loss due to optic neuropathy (defined as a loss of two lines of vision or a new visual field defect within the last 180 days); 2. Corneal involvement in the study did not improve after medical intervention; 3. Active TED: CAS in the study eyes before initial administration decreased by =2 points compared with screening; 4. The exophthalmia of the study eye before initial administration was reduced by =2 mm compared with that during screening. 5. The eyes studied had received orbital radiotherapy or surgery due to TED; 6. Immediate eye surgical intervention is required; 7. Active TED: The cumulative use of glucocorticoids equivalent to =1 g methylprednisolone was used to treat TED[if glucocorticoids of lower cumulative dose (3 times the upper limit of normal value (ULN); Aspartate aminotransferase (AST) >3 times ULN; Serum creatinine (Cr) =1.5 ULN; 16. The presence of poorly controlled diabetes at the time of screening (defined as =9.0% HBA1c at the time of screening or >10% change in dosage of a new diabetes drug or currently prescribed diabetes drug within 60 days prior to screening); 17. Poor thyroid function control was defined as free trii
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of exophthalmos response of the study eye;Mass Cytometry; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of exophthalmos response of the study eye;The mean change in the exophthalmos of the study eye from baseline;Percentage of subjects with active TED with a study eye CAS value of 0 or 1;Mean change from baseline in investigational eye CAS values in active TED patients;Diplopia response rate in study eye of TED patients;Incidence of adverse events (AES) and serious adverse events (SAE);laboratory examination;physical examination;vital signs;12-lead electrocardiogram (ECG);pharmacokinetic parameters;immunogenicity; | — |
Countries
China
Contacts
Public ContactXianqun Fan
Shanghai Ninth people's Hospital,Shanghai jiaoTong University School of Medicine
Outcome results
None listed