A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome
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
- 21
- 主要终点
- Change from baseline in ESSDAI score 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 primary Sjögren's syndrome.
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 —（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 primary Sjögren's syndrome according to the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
- •Evidence of active disease at screening
- •Willing and able to provide written informed consent
排除标准
- •Secondary Sjögren's syndrome or other clinically significant autoimmune or inflammatory diseases
- •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
ESG206 Low Dose
ESG206 Low Dose Injection administered by intravenous infusion
干预措施: ESG206 (Drug)
ESG206 High Dose
ESG206 High Dose Injection administered by intravenous infusion
干预措施: ESG206 (Drug)
Placebo
Placebo Injection administered by intravenous infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in ESSDAI score compared with placebo.
时间窗: Up to approximately 25 weeks
ESSDAI is a validated clinical disease activity index for Sjögren's syndrome. It includes 12 organ-specific domains, each scored by the investigator according to severity using 3- or 4-level scales. Weighted domain scores are summed to generate a total score (maximum score: 123). Domains include constitutional, lymphadenopathy, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral nervous system, central nervous system, hematological, and biological domains. Higher scores on the ESSDAI scale are associated with poorer health states.
次要结局
未报告次要终点