NCT07684157尚未招募2 期
A Phase Randomized, Double-blind, Placebo-controlled Evaluate the Efficacy and Safety IIa Study of JAB-8263 in Patients With Active Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Evaluate the overall safety and tolerability of JAB-8263
研究概览
简要总结
This study is an open-label, multi-center Phase IIa study. The study is divided into two phases. The first phase is a safety exploration phase. Participants with active rheumatoid arthritis were enrolled and treated with JAB-8263 alone for 4 weeks. The purpose is to evaluate the safety, PK/PD characteristics and preliminary effectiveness of JAB-8263 in participants with active RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years old and <75 years old at the time of signing the informed consent form, regardless of gender;
- •Active rheumatoid arthritis, ESR or C-reactive protein> upper limit of normal
- •Meets the 2010 American College of Rheumatology ACR/EULAR RA classification standards
- •Participants have recovered from adverse reactions to previous antirheumatic treatment.
排除标准
- •Use of topical glucocorticoids within 2 weeks before the first dose of investigational product or have received epidural, intraarticular, intramuscular, oral or intravenous glucocorticoids within 4 weeks, and do not use adrenocorticotropin;
- •Use of NSAIDs within 1 week before first dose of investigational product
- •Known or suspected allergies to the investigational product or any of its components;
- •Current active shingles virus infection, including shingles or herpes simplex types 1 and 2 (confirmed by physical examination and medical history); participants had a history of severe herpes infection, including any disseminated disease, shingles in multiple skin areas, herpes encephalitis, ocular herpes, or recurrent shingles (2 episodes greater than or equal to 2 episodes within 2 years);
- •Have evidence of active tuberculosis (TB) or have previously had evidence of active TB and have not received appropriate documented treatment;
结局指标
主要结局
Evaluate the overall safety and tolerability of JAB-8263
时间窗: Up to approximately 12week
Safety assessments including but not limited to TEAEs, SAEs, deaths and changes in clinical laboratory measures
次要结局
- American College of Rheumatology 20 Response Rate (ACR20 Response Rate)(Up to approximately 12week)
- American College of Rheumatology 50 Response Rate (ACR50 Response Rate)(Up to approximately 12week)
- American College of Rheumatology 70 Response Rate (ACR70 Response Rate)(Up to approximately 12week)
- Clinical Disease Activity Index Good Response Rate (CDAI Good Response Rate)(Up to approximately 12week)
- Simplified Disease Activity Index Good Response Rate (SDAI Good Response Rate)(Up to approximately 12week)
研究者
研究点 (1)
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