Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of subjects reach to PASI 75 response at 16 weeks
研究概览
简要总结
This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults
详细描述
This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.
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
- •Inclusion Criteria:
- •Provide written informed consent before any study assessment is performed.
- •Male or female at least 18 years of age at screening.
- •Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis.
- •Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- •The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening.
排除标准
- •Diagnosis of psoriasis at screening is not chronic plaque psoriasis
- •Severe infection or systemic infection before baseline
- •There are other skin problems that researchers believe will hinder the evaluation of psoriasis.
- •Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis.
- •The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study.
- •Those who are allergic to the study ingredients or excipients, or who are allergic to other biological agents.
- •There is evidence that hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) confirmation test is positive.
- •Subject's medical history, symptoms and examination results suggest active tuberculosis or latent tuberculosis.
- •Laboratory tests have clinical implications at screening, and the investigators believe that participation in the study may pose unacceptable risks to the subject or impede data analysis.
- •Women who are pregnant or breastfeeding at screening or at baseline
- •The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol.
研究组 & 干预措施
Treatment group C
SHR-1314 high dose short intervals of subcutaneous injection
干预措施: Placebos (Biological)
Treatment group A
SHR-1314 low dose short intervals of subcutaneous injection
干预措施: IL-17A Antagonist (Biological)
Treatment group B
SHR-1314 high dose long intervals of subcutaneous injection
干预措施: IL-17A Antagonist (Biological)
Treatment group B
SHR-1314 high dose long intervals of subcutaneous injection
干预措施: Placebos (Biological)
Treatment group C
SHR-1314 high dose short intervals of subcutaneous injection
干预措施: IL-17A Antagonist (Biological)
Placebo group
Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
干预措施: IL-17A Antagonist (Biological)
Placebo group
Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
干预措施: Placebos (Biological)
结局指标
主要结局
Proportion of subjects reach to PASI 75 response at 16 weeks
时间窗: 16 week
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 16
次要结局
- Proportion of subjects achieving PASI 90 response at week 16(16 week)