NCT05795621已完成2 期
A Multicenter, Randomized, Double-masked, Placebo-controlled Phase II/III Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Active Thyroid Eye Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- The proptosis responder rate of the study eye (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).
研究概览
简要总结
This is a multicenter, randomized, double-masked, placebo-controlled Phase II/III study in subjects with active thyroid eye disease. Approximately 114 subjects meeting study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by smoking status
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Male or female subject between the ages of 18 and 80 years, inclusive, at Screening.
- •Weight between 45 and 100 kg (inclusive).
- •Clinical diagnosis of Graves' disease associated with active TED with a CAS ≥ 3 for at least one eye at Screening and Baseline.
- •Moderate-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with at least two of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
- •Female Subjects should be fertile women who are sterile or have a negative blood pregnancy test during the screening period and who agree to take contraceptive measures within 120 days from the screening period to the last medication; Male subjects should agree to use contraception from the screening period to 120 days after the last dose.
排除标准
- •Subjects will be ineligible for study participation if they meet any of the following criteria:
- •At the time of screening, according to the subject's chief complaint or medical record, the time of first symptoms of active thyroid eye disease appeared in > 270 days;
- •Optimal corrected vision loss due to optic neuropathy, defined as two lines of vision loss due to optic neuropathy within the past 180 days, new visual field defects, or color vision impairment secondary to optic nerve involvement;
- •Corneal ulcers with no relief after treatment were determined by the investigator;
- •Baseline CAS decreased by more than 2 points compared with screening;
- •At any time prior to baseline or during the study period planned to receive orbital radiation therapy or TED specific surgery, including orbital decompression, strabismus surgery, and eyelid retraction correction;
- •Poor thyroid function control was defined as free triiodothyronine (FT3) or free tetriodothyronine (FT4) deviated more than 50% from the normal reference range of the local research center laboratory during screening;
结局指标
主要结局
The proptosis responder rate of the study eye (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).
时间窗: Week 12 for phase II, Week 24 for phase III
proptosis assessment: amount of protrusion of the eye from the orbital rim measured by Hertel exophthalmometer
次要结局
- Mean change from Baseline in proptosis measurement in the study eye.(Baseline to Week 12 and Week 24 for phase II, Baseline to Week 24 for phase III)
- The proptosis responder rate of the study eye.(Week 24 for phase II)
- The diplopia responder rate of the study eye.(Week12 and Week24 for phase II, Week 24 for phase III)
- Mean Change of the CAS value in the study eye.(Baseline to Week 12 and Week 24 for phase II)
- The overall responder rate in the study eye.(Week12 and Week24 for phase II, Week 24 for phase III)
- Percentage of subjects with a CAS value of 0 or 1 in the study eye.(Week12 and Week24 for phase II, Week 24 for phase III)
研究者
研究点 (1)
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