CTIS2023-504863-17-00招募中1 期
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) - 230LE305
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 347
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants who completed the parent 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), Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations
排除标准
- •Early Part A or Part B parent study (230LE301) 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 extended treatment period (ETP)], Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator., Other protocol defined Exclusion criteria may apply
研究者
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