This is a single-arm, prospective, open-label, Phase II study that explored the efficacy and safety of SHR-1314 in active moderate to severe Graves' Orbitopathy. The study consists of a 6-week screening period, a 16-week treatment period, and a 12-week follow-up period. Eighteen adult patients with active moderate to severe Graves' Orbitopathy will be enrolled. Eligible subjects will receive SHR-1314 subcutaneously. The primary endpoint was the proptosis responder rate and will be evaluated at 16weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
SHR-1314 subcutaneously
Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medical
Shanghai, Shanghai Municipality, China
the proptosis responder rate
Proptosis responder is defined as a ≥ 2 mm reduction from Baseline in proptosis in the study eye, without deterioration \[≥ 2 mm increase\] of proptosis in the fellow eye)
Time frame: week 16
Proportion of patients achieving response in reduction of clinical activity score(CAS)
reduction of CAS is defined as reduction of ≥ 2 points of CAS from Baseline to Week16.
Time frame: week 16
Overall responder rate
Overall responder rate is defined as percentage of subjects with≥ 2-point reduction in CAS AND ≥ 2 mm reduction in proptosis from Baseline, provided there is no corresponding deterioration \[≥ 2-point/mm increase\] in CAS or proptosis in the fellow eye at Week 16
Time frame: week 16
The percentage of subjects with a CAS value of 0 or 1 in the study eye
the clinical activity score of subject is 0 or 1.
Time frame: week 16
The mean change from Baseline to Week 16 in proptosis measurement in the study eye
Average change in proptosis in study eye.
Time frame: week 16
Diplopia response rate at Week16
Proportion of participants with Baseline diplopia \> 0 and a reduction of ≥ 1 grade with no corresponding deterioration (≥ 1 grade worsening) in the fellow eye at Week 16.
Time frame: week 16
The mean change from Baseline to Week 16 in the GO-QoL score
Average change in the Graves' ophthalmopathy quality of life questionnaire (GO-QOL) score. The GO-QoL contains 8 questions on visual functioning and 8 questions on appearance; answers on each subscale are transformed to scores ranging from 0 (worst) to 100 (best).
Time frame: week 16
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