NCT01747538终止3 期
A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 281
- 主要终点
- Proportion of subjects with an occurrence of uveitic disease through Day 168
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.
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
- •Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
- •Controlled uveitic disease in both eyes
- •Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
- •Effective contraceptive measures
排除标准
- •Infectious uveitis and masquerade syndromes
- •Isolated anterior uveitis
- •Contraindication to mydriatics
- •Active tuberculosis disease
- •History of allergic or anaphylactic reactions to monoclonal antibodies
- •History of recurrent infection or predisposition to infection; active ocular infection
- •Pregnant or nursing women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Dose 1 gevokizumab
Experimental
干预措施: Dose 1 gevokizumab (Drug)
Dose 2 gevokizumab
Experimental
干预措施: Dose 2 gevokizumab (Drug)
结局指标
主要结局
Proportion of subjects with an occurrence of uveitic disease through Day 168
时间窗: Day 0 through Day 168
次要结局
- Time to first occurrence of uveitic disease(Day 0 through Day 168)
研究者
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