Multi-centre, Open-label, Expanded Access Trial of Spesolimab i.v. 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
- 11
- 试验地点
- 9
- 主要终点
- Occurrence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This Expanded Access trial in Japan 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.
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 to 6 times. 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
- Na
- 干预模型
- Single Group
- 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
干预措施: spesolimab (Drug)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events (TEAEs)
时间窗: From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.
Number of patients with any treatment emergent adverse events (TEAEs) is reported. An adverse events (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.
次要结局
- Occurrence of Treatment Emergent Serious Adverse Events (SAEs)(From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.)
- Occurrence of Treatment Emergent Adverse Events of Special Interest (AESIs)(From first administration of study drug until last administration of study drug + 16 weeks of follow up, up to 6.3 months.)