This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Placebo group: 10 mg/kg of placebo on Day 1, followed by 20 mg/kg, q3W of placebo for the following 3 infusions.10 mg/kg of IBI311 at Week 12, followed by 20 mg/kg, q3W of IBI311 for the remaining 3 infusions.
IBI311 group: 10 mg/kg of IBI311 on Day 1, followed by 20 mg/kg, q3W of IBI311 for the remaining 7 infusions; .
Peking University People's Hospital
Beijing, Beijing Municipality, China
The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye.
Proptosis assessment: proptosis of the study eye as measured by Hertel exophthalmometer.
Time frame: Week 12
Overall responder rate in proptosis of the study eye.
Proptosis assessment: proptosis of the study eye as measured by Hertel exophthalmometer.
Time frame: Weeks 12 and 24
Percentage of subjects with a CAS value of 0 or 1
CAS Assessment Form
Time frame: Weeks 12 and 24
Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia)
Gorman subjective diplopia score.
Time frame: Weeks 12 and 24
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