EUCTR2020-005587-55-NO进行中（未招募）1 期
An open-label, long-term extension trial of spesolimab treatment in adult patients with Hidradenitis Suppurativa (HS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients who have completed treatment in the parent HS spesolimab trial (1368-0052) without premature discontinuation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •- Patients who experienced study treatment-limiting adverse events during the 1368-0052 parent trial.
- •- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- •- Any condition which in the opinion of the investigator affects the safety of the patient, the patient’s ability to participate in this trial or could compromise the quality of data.
- •- Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour).
- •- Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months (i.e. active suicidal thoughts with method and intent but without specific plan, or active suicidal thoughts with method, intent and plan).
研究者
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