jRCT2031240075进行中（未招募）不适用
Lunsayil LTE: An extension trial assessing long-term spesolimab treatment in patients with Hidradenitis Suppurativa (HS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
- 主要终点
- treatment emergent adverse events (TEAE)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
- •Participants who have completed treatment in the parent HS spesolimab trial without premature discontinuation and are willing and able to continue treatment in this trial. etc.
排除标准
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
- •Participants who require/ intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial. etc.
结局指标
主要结局
treatment emergent adverse events (TEAE)
时间窗: 16 weeks after the last study treatment
The occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including REP
次要结局
未报告次要终点
研究者
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