jRCT2031230262招募中不适用
A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in 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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 474
- 主要终点
- CLA-IGA-R Erythema score 0 or 1
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
- •histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
- •Must have active cutaneous manifestations that meet criteria
- •Must have a CLASI-A score >= 10
- •Must have an active CLE lesion despite an adequate trial of antimalarial treatment
- •NOTE: Other protocol defined Inclusion criteria may apply.
排除标准
- •Any active skin conditions other than CLE that may interfere with the study assessments of CLE
- •Active severe lupus nephritis
- •Active neuropsychiatric SLE
- •Use of intralesional corticosteroids within 1 week prior to Screening and during the study
- •Use of immunosuppressive or disease-modifying treatments for SLE or CLE (via an oral, IV, or SC route) that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose
- •NOTE: Other protocol defined Exclusion criteria may apply.
结局指标
主要结局
CLA-IGA-R Erythema score 0 or 1
时间窗: Week 16
Proportion of participants who achieve a CLA-IGA-R Erythema score of 0 or 1
CLASI 70 response
时间窗: Week 24
Proportion of participants who achieve CLASI 70 response, defined as >= 70% decrease in CLASI-A score from Baseline
次要结局
未报告次要终点
研究者
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