Effectiveness and Safety of Xeligekimab in Adult Patients with Moderate to Severe Plaque Psoriasis: a Multicenter, Prospective, Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12
研究概览
简要总结
Xeligekimab Injection was approved in China on August 20, 2024, for treating adults with moderate to severe plaque psoriasis who are candidates for systemic treatment or phototherapy. Despite the promising efficacy and safety shown in the phase III clinical trial, real-world data is needed to further support clinical decisions for this patient group. This study aims to evaluate the effectiveness and safety of xeligekimab in real-world clinical settings for adults with moderate to severe plaque psoriasis.
详细描述
This multicenter, prospective, real-world study will consecutively enroll moderate to severe plaque psoriasis adult patients who are anticipated to receive xeligekimab for the first time. All patients will receive routine clinical care. The study will evaluate the treatment's effectiveness and safety and observe treatment patterns for up to 52 weeks.
Objectives:
Primary Objective:
To evaluate the effectiveness and safety of xeligekimab in adult patients with moderate to severe plaque psoriasis in clinical practice.
Secondary Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients who meet all the following criteria will be included in this study:
- •Patients 18 years of age or older;
- •Patients with a confirmed clinical diagnosis of moderate to severe plaque psoriasis at the time of screening;
- •Patients who are deemed suitable for xeligekimab therapy by a clinician and are anticipated to receive xeligekimab treatment for the first time;
- •Patients who are willing to sign the informed consent form.
排除标准
- •Patients who meet any of the following exclusion criteria will be excluded from this study:
- •Patients with drug-induced psoriasis (such as new-onset or exacerbated psoriasis caused by β-blockers, calcium channel blockers, or lithium);
- •Patients with hypersensitivity to the active ingredient or any excipient in xeligekimab injection solution;
- •Patients with other contraindications specified in the prescribing information;
- •Patients concurrently participating in other clinical studies;
- •Patients under other conditions or circumstances that investigators do not consider appropriate to include.
研究组 & 干预措施
Xeligekimab
Patients who are anticipated to receive xeligekimab for the first time
干预措施: Xeligekimab injection (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index 90 (PASI90) response rate at Week 12
时间窗: Week 12
The proportion of patients achieving a ≥90% improvement in PASI score at Week 12 compared to the baseline.
次要结局
- PASI90 response rates at Weeks 4, 24, 36, and 52(Weeks 4, 24, 36, and 52)
- PASI75 and PASI100 response rates at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36, and 52)
- Physician's Global Assessment (PGA) 0/1 response rates at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36, and 52)
- Dermatology Life Quality Index (DLQI) 0/1 response rates at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36, and 52)
- Treatment patterns: treatment statuses(Weeks 12, 24, 36, and 52)
- Treatment patterns: reasons for non-persistence, discontinuation, switching, and re-initiation of therapy(Weeks 12, 24, 36, and 52)
- Treatment patterns: treatment regimens after switching(Weeks 12, 24, 36, and 52)
- Adverse Events (AEs)(Week 52)