NCT00404885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 Anterior 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
- 108
- 试验地点
- 30
- 主要终点
- anterior chamber cells
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 anterior 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 anterior, anterior and intermediate- or panuveitis
- •Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated.
- •Grade of 2+ or higher for anterior chamber cells at time of enrollment
- •Considered by the investigator to require corticosteroid-sparing therapy.
- •Subjects not planning to undergo elective ocular surgery during the study
排除标准
- •Uveitis of infectious etiology
- •Presence of an ocular toxoplasmosis scar
- •An immune suppression regimen that includes an alkylating agent within the previous 90 days
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
anterior chamber cells
时间窗: 16 and 24 weeks
次要结局
- BCVA(24 weeks)
- macular thickness(16 and 24 weeks)
研究者
研究点 (30)
Loading locations...
相似试验
已完成
3 期
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-UveitisUveitis, PosteriorUveitis, IntermediatePanuveitisNCT00404612Lux Biosciences, Inc.218
已完成
3 期
A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-UveitisUveitis, PosteriorUveitis, IntermediatePanuveitisNCT00404742Lux Biosciences, Inc.232
已完成
2 期
Study of LX4211 in Subjects With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT00962065Lexicon Pharmaceuticals36
终止
3 期
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel ResectionIleusGastro-Intestinal DisorderNCT05470387Palisade Bio23
已完成
1 期
Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy SubjectsHealthyNCT01913002Lexicon Pharmaceuticals63