A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease
This is a multicenter, open-label outreach study. Participants who have previously participated in and completed CIBI311A201 double-blind treatment can enter this study after signing informed consent. The study included an observation period and an open treatment period. Observation period: From weeks D0 to 24, all subjects will return to the research center every 8 weeks for disease evaluation. If the investigator determines that treatment is required based on predefined criteria, they will enter the open treatment period to receive IBI311 treatment; Otherwise, subjects will continue to be visited every 8 weeks until week 24. Open Treatment period: Subjects entering the open treatment period will receive 8 infusions of IBI311 (initial dose of 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
The first dose was 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The response rate of exophthalmos was studied.
To evaluate the effect of IBI311 on the exophthalmos response rate in the study eye (defined as the percentage of subjects with an exophthalmos reduction of ≥2 mm from baseline in the study eye without an increase of ≥2 mm in the contralaterial eye).
Time frame: After receiving IBI311 treatment for 24 weeks
Overall responder rate (i.e., percentage of subjects with a ≥ 2-point decrease in Clinical Activity Score [CAS] and a ≥ 2 mm decrease from baseline in proptosis in the study eye, and without corresponding deterioration in the fellow eye in the study eye
Total ocular response rate in the study eyes after 4 /8 IBI311 treatments.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on ocular CAS score.
Percentage of subjects with a CAS value of 0 or 1 after 4 /8 IBI311 treatments.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on exophthalmos.
Mean change in exophthalmia from baseline in study eyes after 4 /8 IBI311 treatments.Efficacy of investigational eye therapy after 4 /8 IBI311 treatments
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the efficacy of IBI311 in improving contralateral eye.
After 4 /8 treatments with IBI311,The response rate of exophthalmos in the improving contralateral eye.
Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the efficacy of IBI311 in improving diplopia.
Diplopia response rate after four/eight IBI311 treatments (defined as the percentage of subjects with diplopia at baseline with grade 1 reduction).
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Time frame: After receiving IBI311 treatment for 24 weeks
To evaluate the effects of IBI311 on Graves' ophthalmopathy-specificquality of life (GO-QOL) scores.
Mean change in total GO-QOL questionnaire scores from baseline after 4/8 IBI311 treatments;
Time frame: After receiving IBI311 treatment for 24 weeks
The rate of TED recurrence after discontinuation of IBI311 treatment was assessed
Proportion of subjects entering open treatment due to relapse.
Time frame: After receiving IBI311 treatment for 24 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, association with the study drug and severity of ocular and systemic adverse events (AE), treatment-emergent adverse events (TEAE), and serious adverse events (SAE)
Time frame: After receiving IBI311 treatment for 24 weeks