Multi-centre, Open-label, Expanded Access Program of 900mg Intravenous (i.v.) Spesolimab in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 12
- 主要终点
- Occurrence of Treatment Emergent Adverse Events (AEs)
研究概览
简要总结
This Expanded Access Program in China is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to people with a GPP flare-up who have no alternative treatment options. This means that no therapy exists and participation in a clinical study is not possible.
Participants get a single infusion of spesolimab into a vein. They can get another spesolimab infusion one week after the first infusion if the doctors think it is helpful.
Participants are in the program for about 4 months and visit the study site about 5 times. Participants who benefit from the treatment during that time may repeat the treatment in case they experience a new GPP flare-up. The doctors regularly check participants' health and take note of any unwanted effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Spesolimab single dose treatment
Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab.
干预措施: spesolimab (Drug)
Spesolimab double dose treatment
Patients with Generalized Pustular Psoriasis (GPP) presenting a flare received a single intravenous dose of 900 milligrams of spesolimab. One week after the initial dose, patients received a second intravenous single dose of 900 mg of spesolimab due to persistence of flare symptoms.
干预措施: spesolimab (Drug)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events (AEs)
时间窗: From initial drug administration to: end of study treatment + residual effect period or end of study visit. Up to 16 weeks for the single dose group and up to 17 weeks for the double dose group.
This outcome measured the number of patients with any treatment-emergent adverse event (AE). Treatment-emergent AEs are untoward medical events that appear or worsen during treatment.
次要结局
- Occurrence of Treatment Emergent Serious Adverse Events (SAEs)(From initial drug administration to: end of study treatment + residual effect period or end of study visit. Up to 16 weeks for the single dose group and up to 17 weeks for the double dose group.)
- Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)(From initial drug administration to: end of study treatment + residual effect period or end of study visit. Up to 16 weeks for the single dose group and up to 17 weeks for the double dose group.)