jRCT2041240127招募中不适用
A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST LTE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 322
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants who completed the parent study (Study 230LE301, Part A or Part B) on
- •study treatment (received treatment through Week 48 and attended the last study
- •assessment visit at Week 52)
排除标准
- •Early Part A or Part B parent study treatment terminators (participants who discontinued
- •study treatment before Week 48).
- •Early Part A or Part B parent study terminators (participants who withdrew from parent
- •study participation before Week 52 and did not complete the parent study ETP).
- •Participants who have developed any other medical diseases, conditions, or
- •abnormalities, rendering their participation in the LTE study unsuitable in the opinion of
- •the Investigator.
- •NOTE: Other protocol defined Exclusion criteria may apply.
研究者
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