NCT06112340招募中2 期
A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses 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
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Percentage of Subjects who are Proptosis Responders at Week 24
研究概览
简要总结
The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.
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
- •Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (< 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301
- •Subject has not received any treatment for TED since Week 24 of VGN-TED-301
- •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 Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial
- •Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study
排除标准
- •The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.
研究组 & 干预措施
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 with a ≥ 2 mm reduction of proptosis from baseline as determined by exophthalmometer
次要结局
- Change from Baseline in Proptosis to 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)
- 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)
研究者
研究点 (2)
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