NCT05055934已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving ACR 20 improvement at week 12
研究概览
简要总结
This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject voluntarily signs an informed consent form before any procedures related to the research start;
- •Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;
- •At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
- •There is active PsA before randomization;
- •Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
排除标准
- •Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
- •Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
- •Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
- •A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
研究组 & 干预措施
SHR-1314 injection
Experimental
干预措施: SHR-1314 injection (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of subjects achieving ACR 20 improvement at week 12
时间窗: at week 12
次要结局
- The proportion of subjects who achieved ACR 50 improvement (week 12)(week 12)
- The proportion of subjects who achieved ACR 70 improvement (week 12)(week 12)
研究者
研究点 (1)
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