NCT05366855终止3 期
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 67
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).
详细描述
This study will also evaluate the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP
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
- •Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP
- •Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment
排除标准
- •Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study.
研究组 & 干预措施
IV +SC Imsidolimab
Active Comparator
IV loading dose followed by subcutaneous Imsidolimab
干预措施: Imsidolimab (Biological)
SC Imsidolimab
Active Comparator
Subcutaneous Imsidolimab
干预措施: Imsidolimab (Biological)
SC Placebo
Placebo Comparator
Subcutaneous Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of adverse events
时间窗: Week 24
Incidence of adverse events
次要结局
未报告次要终点
研究者
研究点 (67)
Loading locations...
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