NCT07219420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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 96
- 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
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age inclusive, at the time of signing the informed consent form (ICF)
- •Have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit
- •Have PPPASI ≥12 at the Screening Visit and Baseline Visit
- •Have PPP-IGA ≥3 at the Screening Visit and Baseline Visit
- •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 and having more than 5 active pustules
- •Participant must be a candidate for systemic therapy or phototherapy
排除标准
- •Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score
- •Has the following: palmoplantar PSO (plaque PSO on palms/soles), guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema or chronic hand eczema.
- •Has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or tumor necrosis factor [TNF] inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis)
- •Has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP
- •Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit
- •Is taking or has ever taken an interleukin (IL)-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study
研究组 & 干预措施
Bimekizumab
Experimental
Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.
干预措施: Bimekizumab (Drug)
Placebo
Placebo Comparator
Subjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16
时间窗: At Week 16
PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP. The Investigator will assess the overall severity of PPP using the following 5-point scale: 0 = Clear; 1 = Almost clear; 2 = Mild ; 3 = Moderate; 4 = Severe.
次要结局
- Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period(From Baseline (Day 1) until Safety Follow-Up (up to Week 112))
- Incidence of serious TEAEs from Baseline to the end of the SFU Period(From Baseline (Day 1) until Safety Follow-Up (up to Week 112))
- Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period(From Baseline (Day 1) until Safety Follow-Up (up to Week 112))
- Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period(From Baseline (Day 1) until Safety Follow-Up (up to Week 117))
- Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16(At Week 16)
- PPPASI75 response at Week 16(At Week 16)
- PPPASI90 response at Week 16(At Week 16)
- PPPASI50 response at Week 8(At Week 8)
- PPP-IGA 0/1 response at Week 8(At Week 8)
- Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16(From Baseline to Week 16)
- Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16(From Baseline to Week 16)
- Incidence of serious TEAEs from Baseline to the end of the SFU Period(From Baseline (Day 1) until Safety Follow-Up (up to Week 117))
- Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period(From Baseline (Day 1) until Safety Follow-Up (up to Week 117))
研究者
研究点 (96)
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