NCT07753603招募中3 期
A Phase 3, Randomized, Double-mask, Placebo-controlled Study With Open-label Extension to Evaluate the Efficacy and Safety of Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Measure percentage of participants who are Proptosis Responders at Week 24
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participants must be ≥ 18 years of age at Screening
- •Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye (primary study eye) at Screening and Baseline.
- •Moderate to severe active TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 15 months prior to the Screening visit and usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
- •Participants 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 of the central laboratory) 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
- •Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator.
- •Corneal decompensation unresponsive to medical management.
- •Previous orbital irradiation or orbital surgery in either eye.
- •Any glucocorticoid use (IV or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone or equivalent for the treatment of TED within 8 weeks of Screening.
- •Prior IGF-1R inhibitor therapy for any condition.
研究组 & 干预措施
Double-mask Placebo Arm
Placebo Comparator
Participants receive placebo 0 mg twice daily for 24 weeks.
干预措施: Placebo (Drug)
Double-mask Treatment Arm
Experimental
Participants receive linsitinib 150 mg twice daily for 24 weeks.
干预措施: linsitinib (Drug)
Open-label Extension Treatment Arm
Experimental
Proptosis non-responders/relapsed proptosis responders receive linsitinib 150 mg twice daily for 24 weeks.
干预措施: linsitinib (Drug)
结局指标
主要结局
Measure percentage of participants who are Proptosis Responders at Week 24
时间窗: 24 weeks
The proptosis responder rate is the percentage of participants with a ≥ 2 mm reduction of proptosis from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
次要结局
- Mean change from Baseline in Proptosis to Week 24(24 Weeks)
- Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the overall responder rate at Week 24(24 Weeks)
- Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.(24 Weeks)
- Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in the GO-QoL questionnaire overall score.(24 Weeks)
研究者
研究点 (1)
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