A Prospective, Single-arm, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Vunakizumab in Adults With Moderate-to-severe Plaque Psoriasis Who Have Not Previously Received Biologics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,516
- 试验地点
- 1
- 主要终点
- The overall clinical clearance rate of skin lesions
研究概览
简要总结
This is a multicenter, prospective, observational study of 1516 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe chronic plaque psoriasis. Approximately 50-100 clinical trial centers are planned to participate in the study. The study consisted of a 7-day screening period, a 52-week treatment period and an 8-week safety follow-up period.
The recommended dose of vunakizumab is 240 mg (120 mg in two injections), with subcutaneous injection at week 0, 2, and 4, followed by a dose every 4 weeks and a final injection at week 48 (the actual treatment regimen is based on the clinician's recommendation). After the corresponding assessment at 52 weeks, an 8-week safety follow-up period was entered until the end of the study.
详细描述
The vunakizumab is a humanized IL-17A inhibitor with innovative binding epitopes, which accurately binds to IL-17A, the core pathogenic factor of psoriasis. However, there is still a lack of efficacy and safety data in a large sample size of the Chinese population after marketing. Therefore, this study is intended to observe the efficacy and safety of vunachizumab in a larger population. The clinical efficacy of vunakizumab on special sites and the influence of comorbidity on the treatment of psoriasis are also paid attention to. At the same time, the improvement effect of vunakizumab on the quality of life and mental health of psoriasis patients is explored through patient-reported outcome (PRO) and patient satisfaction survey, so as to develop a clinical program that can benefit psoriasis patients physically and mentally.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age ≥18 years old at the time of signing the informed consent, regardless of gender;
- •Moderate to severe plaque psoriasis was diagnosed;
- •Plan to receive vunakizumab therapy as assessed by the investigator;
- •The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study; Patients voluntarily sign informed consent forms.
排除标准
- •Previous treatment with biological agents: including but not limited to anti-tumor necrosis factor-α (TNF-α), anti-IL-17, anti-IL-17 receptor, anti-IL-12 /IL-23 or IL-23p19 antibody drugs;
- •Severe hypersensitivity to vunakizumab active ingredient or any excipients;
- •Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
- •Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after last receiving the study drug;
- •Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
结局指标
主要结局
The overall clinical clearance rate of skin lesions
时间窗: Three months
1. The proportion of subjects who achieved at least a 90% improvement from baseline in PASI scores by week 12 (PASI 90). (PASI: Psoriasis Area and Severity Index, 0 ≤ PASI ≤ 72, where a higher score indicates a greater extent of the disease and more severe skin lesion severity.) 2. Proportion of subjects achieving sPGA 0/1 response at week 12. (sPGA 0/1 response is defined as an sPGA score of 0 (clear) or 1 (almost clear))
次要结局
- The overall clinical clearance rate of skin lesions(One month， Three months，Twelve months)
- The time when subjects reached PASI 75 and PASI 90 within 12 weeks(Three months)
- The time when subjects reached PASI 75, PASI 90, PASI 100 at 52 weeks.(Twelve months)
- Changes in PASI scores relative to baseline at each visit point during 52 weeks.(Twelve months)
- Response rates of ACR (American College of Rheumatology) 20, ACR50 and ACR70 at week 4, 12, 24 and 52.(One month， Three months， Six months，Twelve months)
- Weeks 12 and 52 Treatment Satisfaction Questionnaire for Medication (TSQM) survey questionnaire.(Three months，Twelve months)
研究者
Gao Xinghua
Distinguished Professor of Cheung Kong Scholars；Vice President, First Affiliated Hospital of China Medical University
First Hospital of China Medical University