2024-520337-80-00招募中3 期
A phase 3, randomized, double-blind, placebo-controlled, multicenter study with open-label extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 10
- 主要终点
- Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16
研究概览
简要总结
To evaluate the efficacy of bimekizumab compared with placebo in participants with PPP at Week 16.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
- •Participant must have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit.
- •Participant must have Palmoplantar Pustulosis Area Severity Index (PPPASI) ≥12 at the Screening Visit and Baseline Visit.
- •Participant must have palmoplantar pustulosis- Investigator Global Assessment (PPP-IGA) ≥3 at the Screening Visit and Baseline Visit.
- •Participant must have pustules on the palms of the hands and/or soles of the feet (at the Screening Visit and Baseline Visit), defined as pustule severity ≥2 in at least 1 region and having more than 5 active white- yellow pustules across all regions.
- •Participant must be a candidate for systemic therapy or phototherapy.
排除标准
- •Participant has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score.
- •Participant has palmoplantar PSO (plaque PSO on palms/soles).
- •Participant has the following: guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema, chronic hand eczema, or folliculitis.
- •Participant has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or TNF inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis).
- •Participant has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP.
- •Participant is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit.
- •Participant is taking or has ever taken an IL-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study.
结局指标
主要结局
Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16
Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16
次要结局
- Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16
- PPPASI75 response at Week 16
- PPPASI90 response at Week 16
- PPPASI50 response at Week 8
- PPP-IGA 0/1 response at Week 8
- Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16
- Change from Baseline in Numerical Rating Scale (NRS) – PPP Pain score in the palmoplantar areas at Week 16
- Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period
- Incidence of serious TEAEs from Baseline to the end of the SFU Period
- Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (10)
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