Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)
研究概览
简要总结
Lichen planopilaris (LPP) is a primary lymphocytic cicatricial alopecia characterized by progressive, permanent hair loss and scalp symptoms such as pruritus and burning. Current treatments-including topical and intralesional corticosteroids, hydroxychloroquine, and immunosuppressants-are often inadequate, with limited evidence for efficacy and frequent treatment switching or discontinuation due to side effects or lack of response.1,2 Recent systematic reviews and meta-analyses highlight the need for new, targeted therapies. 3,4 Nemolizumab, an IL-31 receptor antagonist, FDA-approved for prurigo nodularis and atopic dermatitis, has demonstrated efficacy in pruritic and fibrosing dermatoses, making it a rational candidate for LPP.
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
- •Age ≥18 years.
- •Clinical and/or histopathologic diagnosis of LPP.
- •Presence of scalp pruritus.
- •Average Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4 in the 7 days prior to Day
- •Ability and willingness to provide written informed consent and comply with study procedures.
- •Willingness to undergo optional scalp biopsy for research purposes.
排除标准
- •Other forms of alopecia that may interfere with study assessments.
- •Any systemic disease associated with hair loss.
- •Inflammatory or infectious scalp disease that may interfere with the study.
- •Any other conditions associated with pruritus.
- •Prior use of nemolizumab.
- •Current treatment with systemic or topical JAK inhibitors or biologics (unless appropriate washout period completed; minimum 12 weeks).
- •Current treatment with DMARDs (unless appropriate washout period completed; minimum 12 weeks).
- •Prior treatment failure of scarring alopecia with systemic or topical JAK inhibitors or
- •biologics.
- •Current treatment with topical or intralesional corticosteroids (unless appropriate washout period completed; minimum 4 weeks).
- •Any other current treatments for hair loss (e.g., oral/topical minoxidil, PRP) unless stable for at least 6 months or 3 months washout completed.
- •Allergy or hypersensitivity to nemolizumab or any excipients.
- •Pregnancy or unwillingness to use highly effective contraception.
- •Any medical condition that, in the opinion of the investigator, may interfere with study participation or interpretation of results.
研究组 & 干预措施
Patients receive nemolizumab injections every 4 weeks, weight based dosing
干预措施: Nemolizumab (Drug)
结局指标
主要结局
Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)
时间窗: 24 weeks
Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)
时间窗: 24 weeks
次要结局
- Change from baseline at 24 weeks in Peak Pruritus NRS.(24 weeks)