NCT07760155尚未招募2 期
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Systemic Lupus Erythematosus
Shanghai Escugen Biotechnology Co., Ltd20 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 20
- 主要终点
- SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with Systemic Lupus Erythematosus (SLE).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years of age) with a confirmed diagnosis of Systemic Lupus Erythematosus
- •Evidence of active disease at screening
- •Willing and able to provide written informed consent
排除标准
- •Have other autoimmune diseases that may interfere with the assessment of SLE
- •Prior or recent use of prohibited immunomodulatory therapies
- •Clinically significant infections, malignancies, or uncontrolled medical conditions
- •Pregnancy or breastfeeding
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ESG206 High Dose
Experimental
干预措施: ESG206 (Drug)
ESG206 Low Dose
Experimental
干预措施: ESG206 (Drug)
结局指标
主要结局
SLE Responder Index (SRI)-4 response rate at Week 25 compared with placebo
时间窗: Up to approximately 25 weeks
次要结局
未报告次要终点
研究者
研究点 (20)
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