NCT00404612已完成3 期
A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 40
- 主要终点
- vitreous haze
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis
- •Current uveitis therapy must conform to one of the following:
- •Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
- •Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
- •Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
- •Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
- •Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy
- •Grade of 2+ or higher for vitreous haze at time of enrollment
- •Considered by the investigator to require immunomodulatory therapy.
- •Not planning to undergo elective ocular surgery during the study
排除标准
- •Uveitis of infectious etiology
- •Clinically suspected or confirmed central nervous system or ocular lymphoma
- •Primary diagnosis of anterior uveitis
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
LX211, 0.2 mg/kg
Active Comparator
干预措施: LX211 (Drug)
LX211, 0.4 mg/kg
Active Comparator
干预措施: LX211 (Drug)
LX211, 0.6 mg/kg
Active Comparator
干预措施: LX211 (Drug)
结局指标
主要结局
vitreous haze
时间窗: 16 and 24 weeks
次要结局
- BCVA(24 weeks)
研究者
研究点 (40)
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