An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 108
- 试验地点
- 66
- 主要终点
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study.
The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.
At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial
- •Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation
- •Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial
- •Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
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 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
- •Patients with congestive heart disease, as assessed by the investigator
- •Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal)
- •Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly)
- •Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- •Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
- •Further exclusion criteria apply
研究组 & 干预措施
Treatment group
Up to 260 weeks
干预措施: Spesolimab (Drug)
结局指标
主要结局
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
时间窗: From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
TEAEs were defined as all adverse events (AEs) occurring between start of treatment in this extension trial and the end of its residual effect period. Adverse events that started before first intake of trial medication in the extension trial and deteriorated under treatment during the extension trial were also considered as 'treatment-emergent'.
次要结局
- Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96(Week 48 and Week 96)
- Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96(Week 0 (baseline) and Week 48, Week 96)
- Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96(Week 0 (baseline) and Week 48, Week 96)