A 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Systemic Immunosuppression in Patients With Quiescent, Non-infectious Intermediate, Posterior or Panuveitis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline
研究概览
简要总结
This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression
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
- Triple (Participant, 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
- •Patients who have completed the entire treatment period of the 24 week core study
排除标准
- •Inability or unwillingness to undergo repeated subcutaneous injections; inability to comply with study or follow-up procedures; any medical or psychiatric condition which, in the investigator's opinion wouldpreclude the participant from adhering to the protocol or completing the study per protocol.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
AIN457 300mg every 2 weeks
AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks
干预措施: AIN457 (Drug)
AIN457 300 mg every 4 weeks
AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
干预措施: AIN457 (Drug)
AIN457 150 mg every 4 weeks
AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
干预措施: AIN457 (Drug)
Placebo
Placebo s.c. every 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline
时间窗: Baseline to 52 weeks
Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension
次要结局
- Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value(Baseline to 52 weeks)
- Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies(Baseline to 52 weeks)
- Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension(Baseline to 52 weeks)
- Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension(Baseline to 52 weeks)