A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of a Humanized MG-K10 Mab Injection in Subjects With Prurigo Nodularis.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportions of subjects achieving WI-NRS
研究概览
简要总结
A phase III clinical study to evaluate the efficacy and safety of a humanized MG-K10 mab injection in subjects with prurigo nodularis.administered every 4 weeks for 56 weeks.
详细描述
The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 160 adults with prurigo nodularis were scheduled to receive multiple subcutaneous injections (every 4 weeks for 56 weeks). The study was divided into a screening period (1-4 weeks), a double-blind treatment period (24 weeks), a maintenance treatment period (24 weeks), and a follow-up period (8 weeks).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MG-K10 Humanized Monoclonal Antibody Injection
Every four weeks, subcutaneous injection ，total of 56W
干预措施: Placebo (Drug)
placebo
Every four weeks, subcutaneous injection，Switch to MG-K10 treatment after 24 weeks of administration
干预措施: Placebo (Drug)
结局指标
主要结局
Proportions of subjects achieving WI-NRS
时间窗: week 24
In the experimental group, the weekly mean value of WI-NRS at week 24 was compared with baseline.Proportion of subjects who improved (decreased) by ≥ 4 points
次要结局
- Proportions of subjects achieving IGA PN-S score of 0/1 point(week 24)
- The proportion of subjects whose weekly mean WI-NRS decreased by ≥ 4 from baseline at each evaluation visit(From baseline to week 56)
- The absolute value and percentage change of weekly mean WI-NRS from baseline at each evaluation visit;(From baseline to week 56)
- Duration of onset of response to pruritus(From baseline to week 56)
- the first response to pruritus occurred.(from baseline to the week 24)
- The time when the first intergroup response difference in pruritus occurred(From baseline to week 24)
- The duration of the difference in persistent response to pruritus between groups(From baseline to week 24)
- Proportion of subjects with an IGA PN-S score of 0/1(From baseline to week 56)
- Changes in IGA PN-S scores(From baseline to week 56)
- Proportion of subjects with an IGA PN-A score of 0/1(From baseline to week 56)
- Changes in IGA PN-A scores from baseline(From baseline to week 56)
- Proportion of subjects wit weekly WI-NRS improvement (decrease) of ≥ 4 points and IGA PN-S of 0/1(From baseline to week 56)
- Changes in DLQI scores from baseline(From baseline to week 56)
- Changes in HADS from baseline(From baseline to week 56)
- safety(From baseline to week 56)
- pharmacokinetics(From baseline to week 56)
- pharmacodynamics(From baseline to week 56)
- immunogenicity(From baseline to week 56)