NCT05276063已完成2 期
A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 30
- 主要终点
- Percentage of Subjects who are Proptosis Responders at Week 24
研究概览
简要总结
The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline
- •Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more 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.
- •Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine levels [FT3] < 50% above or below the normal limits) at Screening.
- •Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
排除标准
- •Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- •Corneal decompensation unresponsive to medical management.
- •Previous orbital irradiation or orbital surgery.
- •Any glucocorticoid use (intravenous [IV] or oral) with a cumulative dose equivalent to >= 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.
- •Prior IGF-1R inhibitor therapy for any condition.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Arm
干预措施: Placebo (Drug)
Low Dose
Active Comparator
Active Arm Low Dose Linsitinib
干预措施: Linsitinib (Drug)
High Dose
Active Comparator
Active Arm High Dose Linsitinib
干预措施: Linsitinib (Drug)
结局指标
主要结局
Percentage of Subjects who are Proptosis Responders at Week 24
时间窗: 24 weeks
Percentage of Subjects Who Are Proptosis Responders at Week 24
时间窗: 24 weeks
Proptosis response is defined as a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
次要结局
- Percentage of Subjects who are Diplopia Responders at Week 24(24 weeks)
- Percentage of Subjects who are Overall Responders at Week 24(24 weeks)
- Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)(24 weeks)
- Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.(24 weeks)
- Change from Baseline in Proptosis to Week 24 (Study Eye)(24 weeks)
- Percentage of Subjects Who Are Overall Responders at Week 24(24 weeks)
- Percentage of Subjects With a CAS Value of 0 or 1 at Week 24(24 weeks)
- Change From Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.(24 weeks)
研究者
研究点 (30)
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