Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIa Study to Investigate Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacogenomics of Multiple Intravenous Doses of BI 655130 in Patients With Palmoplantar Pustulosis (PPP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 18
- 主要终点
- Number of Participants With Drug-related Adverse Events (AEs)
研究概览
简要总结
The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 18 to 65 years of age at screening.
- •Palmoplantar Pustulosis
- •Further inclusion criteria apply
排除标准
- •Presence or known history of anti- Tumor necrosis factor (TNF)-induced Palmoplantar Pustulosis (PPP)-like disease.
- •Active or latent tuberculosis
- •Further exclusion criteria apply
研究组 & 干预措施
Spesolimab (low dose)
干预措施: Spesolimab (low dose) (Drug)
Spesolimab (high dose)
干预措施: Spesolimab (high dose) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Drug-related Adverse Events (AEs)
时间窗: From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.
Number of participants with drug-related AEs are presented.
Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16
时间窗: Week 16
Percentage of participants who achieved 50% reduction in ppPASI score was assessed by ppPASI50. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): \[(E+P+D) x A x 0.2 (right palm)\] + \[(E+P+D) x A x 0.2 (left palm)\] + \[(E+P+D) x A x 0.3 (right sole)\] + \[(E+P+D) x A x 0.3 (left sole)\].
次要结局
- Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16(Week 16)
- Percent Change From Baseline in the ppPASI at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16(Week 16)
