A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,518
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this SLE study is to evaluate the long-term safety and efficacy of LY2127399 in eligible SLE participants who have completed the core studies (NCT01196091) (NCT01205438).
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
- None
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
- •Have completed 52 weeks of treatment in core studies (NCT01196091) (NCT01205438)
- •Given written informed consent
- •Test negative for pregnancy at the time of enrollment
- •Agree to use a reliable method of birth control
排除标准
- •Unwilling to comply with study procedures
- •Any condition that renders the participants unable to understand the nature and scope and possible consequences of the study
- •Any condition that in the opinion of the investigator poses an unacceptable risk to the participants if study drug would be administered
研究组 & 干预措施
LY 2127399 Q2W
If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.
干预措施: LY2127399 (Drug)
LY 2127399 Q2W
If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks.
干预措施: Placebo (Drug)
LY2127399 Q4W
If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.
干预措施: LY2127399 (Drug)
LY2127399 Q4W
If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Baseline through 4 years
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
次要结局
- Proportion of Participants With Improvement in Lupus Quality of Life(4 years)
- Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response(Week 48)
- Proportion of Participants With a Reduction in Steroid Dose(Baseline through 4 years)
- Change in Anti-double-stranded Deoxyribonucleic Acid Level(Baseline, 4 years)
- Change in SLE Disease Activity Index(Baseline, 4 years)
- Occurrence of New Severe SLE Flares(Baseline through 4 years)