Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis: A Randomised Double-blind Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.
研究概览
简要总结
Study design: A double-blind randomised placebo-controlled trial
Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks.
Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16):
- of patients receiving apremilast compared to placebo;
- within both groups relative to baseline (t=0).
Secondary objectives:
- To prospectively evaluate the clinical efficacy of apremilast.
- To assess the effect of apremilast on patient reported outcomes measures.
- To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.
详细描述
Rationale:
Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease. It is characterized by painful, deep-seated, inflamed boils in the inverse areas of the body, most commonly the axillae, inguinal and anogenital regions.
Systemic therapy with immunosuppressive agents (systemic corticosteroids, dapsone, cyclosporin) has been investigated in the past decades and has shown limited efficacy. The use of the selective immunosuppressant apremilast has not yet been evaluated in HS. The investigators hypothesize a beneficial effect of apremilast in HS patients, similar to the efficacy of apremilast in psoriasis patients. Namely, it has been shown that the immune dysregulation in the pathogenesis of HS shows many similarities with that of psoriasis. Moreover, the TNF-α blocker adalimumab was registered for HS after approval for the treatment in patients with psoriasis.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Apremilast
N=15
干预措施: Apremilast (Drug)
Placebo Oral Tablet
N=5
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.
时间窗: t=16 weeks
measurement by qPCR
Change of expression levels of inflammatory cytokine protein in HS lesional skin.
时间窗: t=16 weeks
measurement by ELISA
次要结局
- Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score(t=0 weeks, t=4 weeks, t=16 weeks)
- Hidradenitis Suppurativa Clinical Response (HiSCR)(t=0 weeks, t=16 weeks)
- Dermatology Life Quality Index (DLQI)(t=0 weeks, t=4 weeks, t=16 weeks)
- Abscesses count(t=0 weeks, t=4 weeks, t=16 weeks)
- Nodule count(t=0 weeks, t=4 weeks, t=16 weeks)
- Numerical Rating Scale (NRS)(t=0 weeks, t=4 weeks, t=16 weeks)
- Incidence of Treatment-Emergent Adverse Events(Multiple time points between t=0 weeks and t=16 weeks)
- Fistula count(t=0 weeks, t=4 weeks, t=16 weeks)
研究者
M.B.A. van Doorn
MD, PhD
Erasmus Medical Center