A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 598
- 试验地点
- 2
- 主要终点
- • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
研究概览
简要总结
This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
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
- Triple (Participant, 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
- •Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.
排除标准
- •Patients with hypersensitivity to ustekinumab or any of the product excipients.
研究组 & 干预措施
DMB-3115
Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment
干预措施: DMB-3115 (Drug)
Stelara
Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115
干预措施: DMB-3115 (Drug)
Stelara
Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115
干预措施: Stelara (Drug)
结局指标
主要结局
• To Evaluate Efficacy of DMB-3115 in Comparison With Stelara
时间窗: Week 8 (For EMA) and 12 (For FDA)
Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction.
次要结局
未报告次要终点