A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
- 试验地点
- 92
- 主要终点
- Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
研究概览
简要总结
RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)
详细描述
This study is a Phase 2 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial
- •Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial
- •Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment
排除标准
- •History of an inflammatory joint disease other than Rheumatoid Arthritis
- •Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator
- •History of cancer within the last 5 years (except for some skin cancers)
- •Any known or suspected condition that would compromise immune status
- •Pregnant or breastfeeding women
研究组 & 干预措施
Rosnilimab SC Dose 1
This arm will receive treatment SC
干预措施: Rosnilimab (Drug)
Rosnilimab SC Dose 2
This arm will receive treatment SC
干预措施: Rosnilimab (Drug)
Rosnilimab SC Dose 3
This arm will receive treatment SC
干预措施: Rosnilimab (Drug)
Placebo
This arm will receive Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
时间窗: Baseline to Week 12
The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints
次要结局
- American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12(Baseline to Week 12)
- American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12(Baseline to Week 12)