jRCT2031220439招募中不适用
A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 864
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 and 230LE304) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52.
排除标准
- •Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52).
- •Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52 week treatment period).
- •Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)
- •Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
结局指标
主要结局
-
-Incidence of TEAEs -Incidence of SAEs
次要结局
未报告次要终点
研究者
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